Z-0228-2023 Class II Ongoing
FDA device recall Z-0228-2023 was initiated by LeMaitre Vascular, Inc. on September 30, 2022 and is designated Class II. Reason for recall: Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the… The recall status is ongoing. Affected quantity: 72 (OUS only).
Recall Details
- Product Type
- Devices
- Report Date
- November 23, 2022
- Initiation Date
- September 30, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 (OUS only)
Product Description
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
Reason for Recall
Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.
Distribution Pattern
No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
Code Information
Lots XSL0097, XSL0098, and XSL0099