LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: OTW3080 OTW3080¿ OTW3081¿ OTW3083¿ OTW3100¿
- 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:
- LeMaitre Vascular, Inc.
- Reason for Recall:
- Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
Product Codes/Lot Numbers:
Lot Numbers: OTW3080 OTW3080¿ OTW3081¿ OTW3083¿ OTW3100¿
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0379-2016
Related Recalls
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
LeMaitre Vascular
The device was incorrectly packed in the wrong size labeled outer packaging.
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.