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..
Reported: November 23, 2022 Initiated: September 30, 2022 #Z-0228-2023
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.
Details
- Recalling Firm
- LeMaitre Vascular, Inc.
- Units Affected
- 72 (OUS only)
- Distribution
- No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.
- Location
- Burlington, MA
Frequently Asked Questions
What product was recalled? ▼
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... Recalled by LeMaitre Vascular, Inc.. Units affected: 72 (OUS only).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2022. Severity: Moderate. Recall number: Z-0228-2023.
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