Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurat

FDA device recall Z-1589-2026 · posted 2026-03-31 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

Increased risk of purge leaks with Generation 1 purge cassettes.

Action taken

Abiomed notified consignees on about 02/18/2026 via UPS next day airmailed letter titled "URGENT MEDICAL DEVICE RECALL (REMOVAL)." Consignees were instructed to identify and quarantine any affected Purge Cassettes in inventory, utilize the provided return shipment label to initiate return of affected cassettes, and complete and return the business reply form provided. Abiomed will provide a credit memo for returned units. Consignees were also encouraged to follow their standard process when ordering their Generation 2 Purge Cassettes, forward the notification to anyone within the facility needing to be aware as well as any customers if the product was further distributed, and to post the notification in a visible area for awareness.

Root cause

Device Design

Status

Open, Classified

Product code

OZD

Quantity affected

33,107 units

Distribution

Worldwide distribution.

Date initiated

2026-02-18

Date posted

2026-03-31

Location

Danvers, MA