ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Tap
FDA device recall Z-2686-2026 · posted 2026-07-10 · Open, Classified
Recall details
- Recalling firm
- Abiomed, Inc.
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DYB
- Quantity affected
- 1,223 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), Fra
- Date initiated
- 2026-06-11
- Date posted
- 2026-07-10
- Location
- Danvers, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Abiomed 23 Fr Sheath (K201116) | Abiomed, Inc. | 2020-06-15 |
| Impella CP Introducer (K192769) | Abiomed, Inc. | 2019-11-18 |