TufTex Embolectomy Catheter recall
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer.…
Why was TufTex Embolectomy Catheter recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots XSL0097, XSL0098, and XSL0099
- 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.…
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 72 (OUS only)
- Distribution
- No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
- Recall date
- November 23, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)