Recall Z-2685-2026
Abiomed, Inc. · initiated June 11, 2026
Class I – dangerous or defective products that could cause serious health problems or death
Product
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
Codes / lots: Pump Set Code 0052-0038; Introducer Product Code 0052-3052. GTIN: 00813502011708, 00813502012729. All current batches in field.
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2685-2026
- Initiated
- June 11, 2026
- Posted by FDA
- July 10, 2026
- Product code
- DYB – Introducer, Catheter
- Quantity
- 1,540 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)…
- Recalling firm
- Abiomed, Inc., Danvers, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2681-2026 Class I | ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2682-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2683-2026 Class I | ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2684-2026 Class I | ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2686-2026 Class I | ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2687-2026 Class I | ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2688-2026 Class I | ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2689-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2690-2026 Class I | ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2691-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2692-2026 Class I | ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |
| Z-2693-2026 Class I | ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | 06/11/2026Open, Classified |