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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93746

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

Open FDA event record

Event summary

Timeline bucket
December 27, 2023
Product types
Device
Classifications
Class II
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 catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 100080 and 0048-0045 - Impella CP with SmartAssist -- ***Added 2/20/24*** (10) 4413 and 004413 - Impella 2.5 Set (11) 5040 and 005040 - Impella 2.5 IMC Pump Set EU (12) 5060 and 005060 - Impella 5.0 IMC Pump Set EU (13) 5064 and 005064 - Impella 5.0 IMC Pump Set Canada (14) 1000115 - Impella CP Pump set, APAC (15) 1000211 - Impella 5.5 Smart Assist Set, JP (16) 1000302 - Impella CP with SmartAssist APAC (17) 1000361 - Impella 5.5 Set AU (18) 1000402 - Impella CP Smart Assist Set (19) 0046-0011 - Impella RP Pump Set, EU (20) 0046-0026 - Impella 5.0 Pump Set ROW (21) 0046-0037 - Impella 5.0 Pump Set APAC (22) 0046-0039 - Impella RP Set APAC (23) 004690-AU - Impella 5.0 Pump Set AU (24) 0048-0002 - Impella CP Pump Set, EU (25) 0048-0002-BR - Impella CP Pump Set BR (26) 0048-0004 - Impella CP Pump Set, Canada (27) 0048-0014 - Impella Smart Assist Set, EU (28) 0048-0024-JP - Impella CP Smart Assist Set, JP (29) 0048-0044 - Impella CP Smart Assist Set, Canada (30) 0048-0047- Impella CP Smart Assist Set APAC (31) 005048-JP - Impella 2.5 Pump Set, Japan (32) 005066-JP - Impella 5.0 Pump Set, Japan (33) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (34) 0550-0004 - Impella 5.5 with SmartAssist Set, CA

Z-1074-2024
Recall number
Z-1074-2024
Initiated
December 27, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Abiomed, Inc.
Quantity
92515

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.

Code information

UDI-DI (1) 00813502011081 (2) 00813502011180 (3) 00813502011227 (4) 00813502011029 (5) 00813502011869 (6) 00813502012811 (7) 00813502011531 and 00813502012828 (8) 00813502011388 (9) 00813502012279 and 00813502011876 All products are affected by IFU Update ***Added 2/20/24*** (10) 813502010947 (11) 4260113630136 (12) 4260113630174 (13) 813502011197 (14) 813502010473 (15) 813502012453 (16) 813502012767 (17) 813502012927 (18) 813502012873 (19) 4260113630273 (20) 813502011821 (21) 813502011937 (22) 813502011951 (23) N/A (24) 4260113630242 (25) 813502011777 (26) 813502011265 (27) 4260113630280 (28) 813502011609 (29) 813502012200 (30) 813502011944 (31) 813502010046 (32) 813502010053 (33) 813502011630 (34) 813502010466

Distribution pattern

Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.