Z-2968-2024Class II

Impella 5.5 Set AU

Name: Z-2968-2024 Impella 5.5 Set AU
Creator: Abiomed, Inc.
Published: 2024-08-05
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2024-08-05 / Open, Classified / root cause: labeling and UDI

FDA source

Abiomed, Inc. began a recall of Impella 5.5 Set AU; Product Code: 1000361 on 2024-08-05. FDA classified it as Class II and gives the reason as "A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential...". 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-2968-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-05
Posted: 2024-09-04
Recalling firm: Abiomed, Inc.
Product: Impella 5.5 Set AU; Product Code: 1000361;
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Reason for recall: A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On August 5, 2024 URGENT MEDICAL DEVICE CORRECTION (NOTIFICATION) letters were sent to consignees. ACTIONS TO BE TAKEN BY CUSTOMER/USER: " Product is NOT being removed from the field and does not need to be returned. " Review, complete all fields, sign, and return the attached business response form (BRF) (refer to Attachment 2) to [email protected]. " Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). " If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. " Post a copy of this notice in a visible area for awareness of this field safety notice. " As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA s MedWatch Adverse Event Reporting Program using the link below: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda At Abiomed, our priority is to our customers and their patients, and that includes the safe and effective use of our products. If you have questions or concerns regarding this notice, please contact your local clinical field staff. Thank you for your cooperation.
Quantity in commerce: 20 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.
Product codes and lots: Product Code: 1000361; UDI-DI: 00813502012927; Serial Numbers: 425570 425332 425331 463954 463955 476358 476357 481131 481130 481129 485279 485278 485280 480079 483437 466172A 491829 491830 491831 491832; Batch Numbers: 2024286281 2024286289 2024286292 2024375505 2024375511 2024398832 2024398833 2024413728 2024413879 2024413882 2024431078 2024431158 2024431171 2024431175 2024431650 2024431652 2024431653 2024431656 2024431673 2024431720;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2968-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2954-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2955-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2956-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2957-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2958-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2959-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2960-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2961-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2962-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2963-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2964-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2965-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2966-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2967-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2968-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2969-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2970-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2971-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04

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)