Z-2113-2023Class I

Impella LD intravascular micro axial blood pump, Product Number 005082

Name: Z-2113-2023 Impella LD intravascular micro axial blood pump, Product Number 005082
Creator: Abiomed, Inc.
Published: 2023-06-14
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2023-06-14 / Open, Classified

FDA source

Abiomed, Inc. began a recall of Impella LD intravascular micro axial blood pump, Product Number 005082 on 2023-06-14. FDA classified it as Class I and gives the reason as "There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2113-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-06-14
Posted: 2023-07-14
Recalling firm: Abiomed, Inc.
Product: Impella LD intravascular micro axial blood pump, Product Number 005082
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Reason for recall: There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
FDA root cause: Under Investigation by firm
Action: An URGENT: MEDICAL DEVICE CORRECTION (NOTIFICATION) dated 6/14/23 was sent to customers. RECOMMENDATIONS: Clinicians are cautioned to position the Impella system carefully in patients with TAVR, and to be aware of this potential interaction. In this situation, clinicians should avoid repositioning while the device is spinning and should turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity to the valve stent structures. If there is low flow observed in a patient implanted with a TAVR while on Impella heart pump support, you should consider damage of the impeller and replace the Impella pump as soon as possible. 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) on the last page of this letter to the Recall Coordinator identified in this document. " 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 (Shashi Thoutam) directly at +1(734) 262-6255 and/or your local clinical field staff. Thank you for your cooperation. Th
Quantity in commerce: 9252 units
Distribution: Worldwide distribution - US Nationwide.
Product codes and lots: UDI-DI: 00813502011227;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2113-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2111-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-14
Z-2112-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-14
Z-2113-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-14
Z-2114-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-14
Z-2115-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-14
Z-2116-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)