Z-1074-2024Class II

Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1)...

Name: Z-1074-2024 Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1)...
Creator: Abiomed, Inc.
Published: 2023-12-27
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2023-12-27 / Open, Classified / root cause: labeling and UDI

FDA source

Abiomed, Inc. began a recall of Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code... on 2023-12-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1074-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-27
Posted: 2024-02-12
Recalling firm: Abiomed, Inc.
Product: 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
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On December 27, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE CORRECTION letters. Customers were informed of the IFU update, which included a New Warning: "To reduce the possibility of fibers being drawn into the Impella, customers should avoid exposing the inlet and cannula section of the Impella Heart Pumps to any surfaces or fluid baths where the device can come into contact with loose or floating fibers." The IFU udpate also includes updates to Potential Adverse Events and Warnings to add potential of cardiac or vascular injury. That part of the recall is classified and tracked under RES 93749. Customers should review the IFU updates and send their response form to the recalling firm. Please forward the recall notice to all impacted parties at your facility as well as any facilities to whom subject product has been forwarded. Post a copy of the notice in a visible area for awareness. Customers with questions may contact [email protected].
Quantity in commerce: 92515
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1074-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1074-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-12

Product code OZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)