Official recall record
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter in
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-07
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Abiomed, Inc.
What the authority reported
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-09-18 · US FDA — Medical Devices
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-base - 2026-09-18 · US FDA — Medical Devices
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-base - 2026-09-18 · US FDA — Medical Devices
Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-bas
All 38 official recall notices naming Abiomed, Inc. on this site →
ProductGuru Recalls republishes official safety information with attribution. We are not
the issuing authority and this page is not advice. If this product is a medical device or
medication, speak to a doctor or pharmacist. Found an error?
Report it — corrections are published.