Abiomed, Inc.: Impella LD intravascular micro axial blood pump, Product Number 005082

Recall number

Z-2113-2023

Recalling firm

Abiomed, Inc.

Product

Impella LD intravascular micro axial blood pump, Product Number 005082

Status

Open, Classified

Initiated

2023-06-14

Posted

2023-07-14

Terminated

not on file

Reason

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.

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

9252 units

Distribution

Worldwide distribution - US Nationwide.

Lot, serial or model codes

UDI-DI: 00813502011227;

510(k) numbers

not on file

PMA numbers

not on file

Product code

OZD

Firm FEI

1220648

Firm city

Danvers

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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