Device product
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..
Z-0228-2023
Product summary
- Event
- Event 91006
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 72 (OUS only)
- Official record key
device-enforcement:Z-0228-2023
Official wording
Reason: 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.
Code information: Lots XSL0097, XSL0098, and XSL0099
Distribution pattern: No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
Derived failure modes
-
Unknown
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.