Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

FDA device recall Z-2457-2026 · posted 2026-06-18 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Action taken

Johnson & Johnson MedTech/Abiomed Issued an URGETN MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 05/18/2026 via UPS 1-day air delivery. The notice explained the reason for notification and potential patient impact Consignees were instructed to review all Impella CP Sets within inventory and quarantine affected units on hand, return all affected units using the provided return shipment label from Sedgwick, and complete and return the provided business response form. Upon receipt of returned product and completed BRF, Abiomed will provide a copy of a credit memo for the amount returned. Consignees were also instructed to forward the notification to anyone in each facility that needs to be informed and to post a copy of the notification in a visible area for awareness. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OZD

Quantity affected

10 units

Distribution

US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan

Date initiated

2026-05-18

Date posted

2026-06-18

Location

Danvers, MA