[pending] TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48,
Pending LLM rewrite. Source: FDA_DEVICE Z-1750-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
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.
- Category
- Medical Device — Devices
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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