FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
- Recall number
- Z-2457-2026
- Recalling firm
- Abiomed, Inc.
- Product
- Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
- Status
- Open, Classified
- Initiated
- 2026-05-18
- Posted
- 2026-06-18
- Terminated
- not on file
- Reason
- 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.
- 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
- 10 units
- Distribution
- US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
- Lot, serial or model codes
- GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).
- 510(k) numbers
- not on file
- PMA numbers
- ["P140003"]
- Product code
- OZD
- Firm FEI
- 1220648
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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