FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
- Recall number
- Z-2689-2026
- Recalling firm
- Abiomed, Inc.
- Product
- ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
- Status
- Open, Classified
- Initiated
- 2026-06-11
- Posted
- 2026-07-10
- Terminated
- not on file
- Reason
- A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Root cause
- Under Investigation by firm
- Action
- An URGENT MEDICAL DEVICE RECALL (CORRECTION) notice dated 06/10/2026 was mailed to consignees. The notice directs consignees to maintain awareness of this recall among practitioners and use appropriate clinical awareness, monitoring, and patient support as needed. Further clinical direction is provided in the notice. The notification is to be forwarded to users and to facilities where product was further distributed. The notice should be visible for awareness. Consignees with any questions can contact OneMD-Field_Actions@its.jnj.com.
- Quantity
- 35,430 units
- Distribution
- Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (JP), Kuwait (KW), Luxembourg (LU), Malaysia (MY), Mexico (MX), Netherlands (NL), Norway (NO), Panama (PA), Poland (PL), Saudi Arabia (SA), Serbia (RS), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), United Arab Emirates (AE), and United Kingdom (GB).
- Lot, serial or model codes
- Pump Set Code 0048-0014; Introducer Product Code 0052-3046. GTIN: 00813502012873, 00813502013344, 00813502013368, 04260113630280. All current batches in field.
- 510(k) numbers
- ["K192769","K201116"]
- PMA numbers
- not on file
- Product code
- DYB
- 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