Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection Systems due to a potential for arterial sheath tip separation or partial tip separation during use.
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: The recall involves a medical device with a structural defect (tip separation) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS, which is a percutaneous catheter. The recall involves 115,458 units distributed worldwide, including the United States, Australia, Canada, China, and Jamaica.
The recall is being issued because of a potential for arterial sheath tip separation or partial tip separation during use. This defect could occur while the device is being used in a medical procedure.
Healthcare providers and facilities that have received these devices should stop using them and contact Boston Scientific for further instructions. Consumers should not attempt to use these medical devices themselves.
The recalled product
- Product
- Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Affected units
- 115,458
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)
- GTIN 00811311020829
- Lot Numbers: 200832
- 200850
- 201057
- 201070
- 201087
- 201113
- 201128
- 201143
- 201157
- 201177
- 201190
- 201220
- 201235
- 201312
- 201333
- 201351
- 201379
- 201407
- 201422
Distribution
Distributed nationwide across the United States.
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