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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79887

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 23, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Tandem Diabetes Care Inc

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

1 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 1

t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.

Z-2471-2018
Recall number
Z-2471-2018
Initiated
April 23, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Tandem Diabetes Care Inc
Quantity
55

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways: A) by triggering a Malfunction 4 Alarm, or B) by triggering a succession of notifications prior to the pump shutting off, including Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low). The alarms in both scenarios notify the user that the pump has stopped delivering insulin.

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 fuel gauge, the component that reads and reports the battery parameters to the pump, could provide inaccurate readings, which present to the user in one of two ways: A) by triggering a Malfunction 4 Alarm, or B) by triggering a succession of notifications prior to the pump shutting off, including Alert 2 (Battery Low), Alert 3 (Battery Very Low) and Alarm 12 (Battery Very Low). The alarms in both scenarios notify the user that the pump has stopped delivering insulin.

Code information

Serial Numbers: 483731, 483930, 483992, 484013, 492055, 492368, 501157, 501177, 501178, 501187, 501191, 501200, 501202, 501205, 501207, 501268, 501285, 501364, 501368, 501370, 501376, 501385, 501386, 501387, 501432, 501435, 501440, 501443, 501444, 501445, 501466, 501479, 501488, 501490, 501491, 501495, 501503, 501508, 501509, 501519, 501522, 501523, 501526, 501535, 501560, 504522, 504531, 504535, 504540, 504753, 504972, 504990, 505025, 90472671, 90488584

Distribution pattern

U.S. Consignees: IN, AZ, UT, TX, NY, NJ, MD, MN, IL, CO, AL, WI, CA, PA, OH, OR, MS, FL, NM, ID, NV, KY, VA,

Field note

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