TufTex Embolectomy Catheters Recalled Due to Incomplete Sterile Barrier Seals
LeMaitre Vascular is recalling TufTex Over-the-Wire Embolectomy Catheters due to incomplete sterile barrier seals discovered during internal testing. Affected catheters may allow contamination during medical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with incomplete sterile seals posing contamination risk. No illnesses or injuries reported; classified as risk-of-harm product without reported injury per Score 3 criterion.
Plain-English summary
LeMaitre Vascular, Inc. is recalling all TufTex Over-the-Wire Embolectomy Catheters due to incomplete seals on the sterile packaging discovered during internal product testing. These catheters are used in vascular procedures to remove blood clots and other obstructions from blood vessels.
During internal testing, the company identified that some units had incomplete seals on their sterile barrier packaging. An incomplete seal could allow the packaged device to become contaminated before use, potentially compromising patient safety during vascular procedures.
Approximately 237,611 units have been distributed nationwide and internationally across 77 countries. The recall affects multiple catalog numbers and product variants, with affected lots identified by specific prefixes (OTW, QOT, XOT, COT).
Patients and healthcare providers should contact LeMaitre Vascular regarding their specific devices and appropriate next steps for replacement or management.
The recalled product
- Product
- TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1
- Manufacturer
- LeMaitre Vascular, Inc.
- Hazard
- incomplete-seal
- sterile-barrier-compromise
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00840663100651
- 00840663100668
- 00840663100675
- 00840663100682
- 00840663100699
- 00840663100705
- 00840663100712
- 00840663100729
- 00840663107551
- 00840663100736
- 00840663100743
- 00840663100750
- 00840663100767
- 00840663100774
- 00840663100781
- 00840663100798
- 00840663100804
- 00840663100811
- 00840663100828
- 00840663100835
Distribution
Distributed nationwide across the United States.
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