Silk Road Medical Recalls ENROUTE Transcarotid Stent Systems Due to Detachment Risk
Silk Road Medical is recalling 455 ENROUTE Transcarotid Stent Systems because the tip/nose cone may detach from the device.
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 (detachment) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Silk Road Medical Inc is recalling 455 units of the ENROUTE Transcarotid Stent System (REF SR-XXYY-CS). The recall was initiated due to complaints that the tip/nose cone may detach from the Transcarotid Stent System.
The affected products are distributed across 41 U.S. states and the District of Columbia. The source text does not specify the number of patients affected or report any injuries or illnesses associated with this defect.
Healthcare providers and patients should contact Silk Road Medical for instructions on how to proceed with the recall and replacement of the affected devices.
The recalled product
- Product
- ENROUTE Transcarotid Stent System REF SR-XXYY-CS
- Manufacturer
- Silk Road Medical Inc
- Hazard
- Affected units
- 455
Distribution
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