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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91363

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

Open FDA event record

Event summary

Timeline bucket
December 22, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Maquet Cardiovascular, LLC

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

2 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 2

Hemopro 2 with Vasoshield, Model VH-4001

Z-0995-2023
Recall number
Z-0995-2023
Initiated
December 22, 2022
Classification
Class II
Status
Ongoing
Quantity
9817 devices

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.

Code information

UDI-DI: 00607567700901; Serial Numbers: 25152107, 25152204, 25152293, 25152463, 25152771, 25153153, 25153273, 25153366, 25153585, 25153847, 25153960, 25154066, 25154880, 25155262, 25155326, 25155785, 25156245, 25156642, 25157016, 25157085, 25157244, 25157700, 25157898, 25158066, 25158152, 25158374, 25158822, 25158965, 25159100, 25159335, 25159572, 25159695, 25159791, 25160255, 25160398, 25160498, 25160712, 25160961, 25161193, 25161423, 25161672, 25162202, 25162407, 25162505, 25163168, 25163281, 25163367, 3000236928, 3000251969

Distribution pattern

US Nationwide. Japan, Germany.

device · product 2 of 2

Vasoshield Syringe Packs, Model VH-5001

Z-0996-2023
Recall number
Z-0996-2023
Initiated
December 22, 2022
Classification
Class II
Status
Ongoing
Quantity
530 units US, 215 units OUS

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.

Code information

UDI-DI: 00607567700468; Serial Numbers: 25147126, 25151632, 25152389, 25152964, 25163138, 25162077

Distribution pattern

US Nationwide. Japan, Germany.

Field note

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