medical HIGH RISK Updated 2026-07-22

Oscor Inc. recalls Abiomed REF: 0052-3006, Introducer Kit for Impella Hemosta

See all recalls from Oscor Inc. →

Recalled Product

Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.

Issued by

FDA

Affected States: MA
Lot/Code Info: All Lots within Expiry/GTIN:00885672009755/00813502011609

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Abiomed REF: 0052-3006, Introducer →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

Abiomed, Inc. recalls ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441,

2026-07-22 · 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.

Argon Medical Devices, Inc recalls Bone Marrow Tray, REF: CB0033TL; CB0355TLA

2026-07-22 · Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Abiomed, Inc. recalls ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-

2026-07-22 · 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.

Abiomed, Inc. recalls ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set C

2026-07-22 · 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.