🔍 RecallPedia

Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

Class I - Dangerous
🏥 Medical Devices Recalled: May 26, 2023 Abiomed Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Abiomed, Inc.
Reason for Recall:
There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

Product Codes/Lot Numbers:

UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2128-2023

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Abiomed

Class I - Dangerous

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Abiomed

Class I - Dangerous

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

Feb 16, 2026 Other Medical Devices View Details →