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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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
Related recalls
Same hazard · device detachment
See all →- SevereElekta Geneva Brachytherapy Applicator Intrauterine Tube Detachment Risk
FDA (Devices) · 2026-07-15
- SevereFletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled
FDA (Devices) · 2026-07-15
- SevereBrachytherapy Applicator Advanced Gynecological Applicator Tip Detachment
FDA (Devices) · 2026-07-15
- SevereMedtronic Harmony Delivery Catheter System Distal Tip Detachment Risk
FDA (Devices) · 2026-07-08
- HighOlympus Thunderbeat II Shears Ultrasonic Mode distal tip detachment risk
FDA (Devices) · 2026-04-29
Similar recalls
- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- SevereSlick Set Endotracheal Tubes recalled for connector disconnection risk
FDA (Devices) · 2023-07-05
- SevereEndotracheal Tube Connector Disconnection Risk Prompts Medical Device Recall
FDA (Devices) · 2023-07-05
- SevereSlick Set Uncuffed Endotracheal Tube Connector Disconnection Risk
FDA (Devices) · 2023-07-05
- SevereSlick Set Uncuffed Endotracheal Tubes recalled for connector disconnection risk
FDA (Devices) · 2023-07-05