🔍 RecallPedia

0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO

Class I - Dangerous
🏥 Medical Devices Recalled: December 4, 2019 Argon Medical Devices Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602.
  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:
Argon Medical Devices, Inc
Reason for Recall:
The stiffness of the soft end of the guidewire caused tissue perforation.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO

Product Codes/Lot Numbers:

Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602.

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1791-2020

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