Oscor Intro Catheter Introducer Kit: Compromised Sterile Barrier
Abiomed is recalling Oscor Intro Introducer Kits due to holes in the outer pouch that may compromise the sterile barrier, potentially exposing patients to harmful bacteria and infections including bacteremia and sepsis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for serious infection (bacteremia, sepsis) resulting from sterile barrier compromise. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3 (High).
Plain-English summary
Abiomed, Inc. is recalling the Oscor Intro Catheter Introducer Kit (Part Number 0052-3025), which is used to guide the Impella Catheter into blood vessels during heart procedures. The kits are available in both trayed and non-trayed versions and have been distributed nationwide and internationally.
The recall was initiated because holes have been found in the outer protective pouch of the Introducer Kits. These holes can compromise the sterile barrier that keeps the product free from bacteria and other harmful micro-organisms. If the sterile barrier is breached, patients are at risk of microbial contamination.
When a sterile product is contaminated with bacteria or other micro-organisms, it can cause serious infections. Specifically, contamination introduced into blood vessels or the access site could lead to bacteremia (infection in the bloodstream) or sepsis (a severe, potentially life-threatening infection).
Patients and healthcare providers with Oscor Intro Introducer Kits should contact their healthcare provider or Abiomed for guidance. Healthcare facilities should check inventory for affected units and follow the manufacturer's instructions for return, replacement, or further management.
The recalled product
- Product
- Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
- Manufacturer
- Abiomed, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: N/A
Distribution
Part of a larger recall action
This product is one of 10 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Abiomed, Inc.
See all →- HighAbiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects
FDA (Devices) · 2026-09-30
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Flag Component Failure
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22
Same hazard · sterile barrier compromise
See all →- HighBARD Dynamic Tip Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- ModerateDisposable Mixing Bowls with Spatula recalled for compromised sterile barrier
FDA (Devices) · 2026-05-06
- SevereTufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier
FDA (Devices) · 2025-05-21
- HighIntroducer Needle REF NDL-107-04 Sterile Packaging Recall
FDA (Devices) · 2025-05-14
- HighGalt Medical Introducer Kit Coaxial Dilator recalled for packaging seal issue
FDA (Devices) · 2025-05-14
Similar recalls
- SevereAbiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella Introducer Kit Recalled Due to Potential Leakage
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
FDA (Devices) · 2026-07-22
- SevereABIOMED Intro Kit Heart Pump Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22