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?

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