TufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier
LeMaitre Vascular is recalling TufTex Over-the-Wire Embolectomy Catheters due to incomplete seals on some packages that compromise the sterile barrier. Affected units were distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard—compromised sterile barrier on a device used in invasive vascular procedures—carries risk of infection or complications if the device is used, and a Class II recall meets the "Severe" threshold per the rubric.
Plain-English summary
LeMaitre Vascular, Inc. is recalling TufTex Over-the-Wire Embolectomy Catheters due to incomplete seals (sterile barrier) observed during internal product testing on some packages. The affected product is a medical device used in vascular procedures.
The recall affects 237,611 units with multiple 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, 1651-88J). Lots not expired with prefixes OTW, QOT, XOT, or COT are affected. The products were distributed nationwide and internationally.
If you have received this product, contact LeMaitre Vascular, Inc. for instructions on the recall and replacement options. Do not use units with incomplete sterile packaging, as they may not maintain sterility and could pose a risk during medical procedures.
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…
- Manufacturer
- LeMaitre Vascular, Inc.
- Affected units
- 237,611
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.
Part of a larger recall action
This product is one of 3 recalled by LeMaitre Vascular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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