FDA Device recall Z-2682-2026
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart…
- FDA Device
- Class I
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class I recall of ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart… by Abiomed, citing 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 visu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2682-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-06-11 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Abiomed |
| Distribution | US |
Product
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
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.
Identifiers
| code_info | Pump Set Code 0048-0003; Introducer Product Code 0052-3046. GTIN: 00813502012279, 00813502011876. All current batches in field. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2682-2026%22
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