Z-0980-2024Class I

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

Name: Z-0980-2024 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 I and gives the reason as "IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling". 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-0980-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-12-27
Posted: 2024-02-09
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 (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist ***Updated February 2024*** (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.0 Pump Set ROW (13) 0046-0037 - Impella 5.0 Pump Set APAC (15) 004680-AU - 5.0 Pump Set AU (16) 0048-0002 - Impella CP Pump Set, EU (17) 0048-0002-BR - Impella CP Pump Set BR (18) 0048-0004 - Impella CP Pump Set, Canada (19) 0048-0014 - Impella CP Smart Assist Set, EU (20) 0048-0024-JP - Impella CP Smart Assist Set, JP (21) 0048-0044 - Impella CP Smart Assist Set, Canada (22) 0048-0047 - Impella CP Smart Assist Set APAC (23) 005040 - Impella 2.5 IMC Pump Set EU (24) 005048-JP - Impella 2.5 Pump Set, Japan (25) 005060 - Impella 5.0 IMC Pump Set EU (26) 005064 - Impella 5.0 IMC Pump Set Canada (27) 005066-JP - Impella 5.0 Pump Set, Japan (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA (30) 1000115 - Impella CP Pump set, APAC (31) 1000211 - Impella 5.5 SmartAssist Set, JP (32) 1000302 - Impella CP with SmartAssist APAC (33) 1000361 - Impella 5.5 Set AU (34) 1000402 - Impella CP Smart Assist Set ***Updated March 15, 2024*** The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation: (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (11) 0046-0011 - Impella RP Pump Set, EU (14) 0046-0039 - Impella RP Set APAC
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Reason for recall: IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Firm notified affected consignees of the updated warnings in the IFU beginning on December 27, 2023. Customers were provided with details of the IFU modifications. Customers should notify everyone at their facility who needs to be informed of this correction. If products have been forwarded to another facility, please notify that facility of the updated IFUs. Post a copy of the recall notice in a visible area for awareness. If you have questions or concerns regarding this notice, please contact [email protected] and/or your local clinical field staff.
Quantity in commerce: 91,914 (65,857 US; 26,075 OUS)
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 (7) 00813502011531 and 00813502012828 (8) 00813502011388 (9) 00813502012279 and 00813502011876 All product IFUs include the Update ***Added February 2024*** (10) 813502010947 (12) 813502011821 (13) 813502011937 (15) N/A (16) 4260113630242 (17) 813502011777 (18) 813502011265 (19) 4260113630280 (20) 813502011609 (21) 813502012200 (22) 813502011944 (23) 4260113630136 (24) 813502010046 (25) 4260113630174 (26) 813502011197 (27) 813502010053 (28) 813502011630 (29) 813502010466 (30) 813502010473 (31) 813502012453 (32) 813502012767 (33) 813502012873 (34) 813502012873 ***Removed from scope March 15, 2024*** (4) 00813502011029 (5) 00813502011869 (6) 00813502012811 (11) 4260113630273 (14) 813502011951

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0980-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0980-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09

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)