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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential for arterial sheath tip separation or partial tip separation during use."
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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