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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92411

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

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Event summary

Timeline bucket
June 29, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Abiomed, 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

Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

Z-2281-2023
Recall number
Z-2281-2023
Initiated
June 29, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
166 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis

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

A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis

Code information

UDI-DI: 00813502012811; Serial Numbers: 409541 409542 409544 411379 416645 416646 416647 416649 418933 418939 418940 419489 421953 421955 422974 422978 423999 425596 428726 428730 429616 429617 429623 429646 429648 429649 429650 429651 429652 429654 430363 430365 430366 430367 430923 430929 430931 431099 431106 431532 431535 431844 431846 431847 431848 431850 431868 431869 431870 432394 432395 432396 432397 432398 432400 432401 432402 432643 432644 432645 432648 432651 433755 433756 434540

Distribution pattern

US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI.