Z-2457-2026Class I

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

Name: Z-2457-2026 Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP
Creator: Abiomed, Inc.
Published: 2026-05-18
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2026-05-18 / Open, Classified

FDA source

Abiomed, Inc. began a recall of Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP on 2026-05-18. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2457-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-05-18
Posted: 2026-06-18
Recalling firm: Abiomed, Inc.
Product: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Product code: OZD Temporary Non-Roller Type Left Heart Support Blood Pump
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 10 units
Distribution: US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
Product codes and lots: GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2457-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2457-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-18

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)