Z-2962-2024Class II

Impella 5.5 with SmartAssist Set, CA

Name: Z-2962-2024 Impella 5.5 with SmartAssist Set, CA
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 with SmartAssist Set, CA; Product Code: 0550-0004 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-2962-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-05
Posted: 2024-09-04
Recalling firm: Abiomed, Inc.
Product: Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
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: 21 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: 0550-0004; UDI-DI: 00813502010466; Serial Numbers: 439898 437211A 437204A 440938 439938 439939 453784 453785 476355 476356 470678 493496 493497 491749 491752 491751 478569A 483483A 491750 485277A 485281A; Batch Numbers: 2024337828 2024338391 2024338394 2024340273 2024341579 2024341586 2024356969 2024356971 2024397878 2024397886 2024399646 2025440057 2025440061 2025448005 2025452639 2025452668 2025484262 2025484276 2025448006 2025500661 2025500668;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2962-2024
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)