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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83433

16 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 27, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic MiniMed

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

16 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 16

MiniMed Insulin Pump, model # MMT-508

Z-1581-2020
Recall number
Z-1581-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
64,174 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All Software Versions

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 2 of 16

MiniMed Paradigm Model 511 Insulin Pump

Z-1582-2020
Recall number
Z-1582-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
30,479

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All Software Versions

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 3 of 16

MiniMed Paradigm 512 Insulin pump

Z-1583-2020
Recall number
Z-1583-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
34,777

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All Software Versions

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 4 of 16

MiniMed Paradigm Insulin pump, model number MMT-712

Z-1584-2020
Recall number
Z-1584-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
74,496

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All software Versions

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 5 of 16

Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E

Z-1585-2020
Recall number
Z-1585-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
36,143

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All software Versions Available outside the US only.

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 6 of 16

Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715

Z-1586-2020
Recall number
Z-1586-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
73,028

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All software versions

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 7 of 16

Medtronic MiniMed Paradigm Insulin pump, model number MMT-522

Z-1587-2020
Recall number
Z-1587-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
88,243

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All software versions

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 8 of 16

Medtronic MiniMed Paradigm Insulin pump, model number MMT-722

Z-1588-2020
Recall number
Z-1588-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
225,498

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All software Versions

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 9 of 16

Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K

Z-1589-2020
Recall number
Z-1589-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
38

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All Software Versions

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 10 of 16

Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K

Z-1590-2020
Recall number
Z-1590-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
17

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All Software versions

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 11 of 16

Medtronic MiniMed Paradigm Insulin pump, model number MMT-523

Z-1591-2020
Recall number
Z-1591-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
23,221

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All software versions 2.4A or lower

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 12 of 16

Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K

Z-1592-2020
Recall number
Z-1592-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
27

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All software versions 2.4A or lower

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 13 of 16

Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K

Z-1593-2020
Recall number
Z-1593-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
10

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All software versions 2.4A or lower

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 14 of 16

Medtronic MiniMed Paradigm Insulin pump, model number MMT-723

Z-1594-2020
Recall number
Z-1594-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
72,850

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All software versions 2.4A or lower

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 15 of 16

Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754

Z-1595-2020
Recall number
Z-1595-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
68,598

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All software versions 2.6A or lower. Available outside the US only.

Distribution pattern

US nationwide distribution including Puerto Rico.

device · product 16 of 16

Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CM

Z-1596-2020
Recall number
Z-1596-2020
Initiated
June 27, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic MiniMed
Quantity
2,322

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
cybersecurity vulnerabilities

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information

All software versions 2.7A or lower. Available outside the US only.

Distribution pattern

US nationwide distribution including Puerto Rico.

Field note

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