Official recall notice
FDA DeviceClass INotable
FDA Recall: ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer
- Recall date
- 2026-07-22
- Brand
- Abiomed, Inc.
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
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.
Product description
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.
Affected products
Pump Set Code 1000323; introducer Product Code 2000342. GTIN 00813502012811. All current batches in field.