Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection System Plus catheters due to a potential for arterial sheath 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 potential for mechanical failure (tip separation) during use, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling the ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS, which is a percutaneous catheter. The recall involves 49,229 units distributed worldwide, including the United States and foreign countries such as Australia, Canada, China, and Jamaica.
The recall was initiated 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 patients should stop using the affected devices and contact Boston Scientific Corporation for further instructions or a replacement. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Affected units
- 49,229
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 00811311021062
- Lot Numbers: 305737
- 305738
- 305913
- 305929
- 305940
- 306079
- 306085
- 306093
- 306097
- 306115
- 306168
- 306178
- 306187
- 306195
- 306200
- 306207
- 306219
- 306232
- 306242
Distribution
Distributed nationwide across the United States.
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