Silk Road Medical Inc: ENROUTE Transcarotid Stent System REF SR-XXYY-CS

Is my product affected?

ENROUTE Transcarotid Stent System REF SR-XXYY-CS

• UPC 00811311020492
• UPC 00811311020522
• UPC 00811311020539
• UPC 00811311020508

Check against the official notice below — it lists the full affected range.

What happened

Silk Road Medical Inc is recalling 455 ENROUTE Transcarotid Stent Systems distributed across 40 U.S. states due to complaints that the tip or nose cone may detach from the device. The affected systems have specific catalog numbers (SR0930CS, SR0940CS, SR1030CS, and SR1040CS) and lot numbers, including lot numbers 17917092, 17923717, 17929776, 17931107, and 301576.

The recall notice does not specify a remedy or instructions for what consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.

Details from the source

Reason for recall: Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System. Distribution: U.S.: AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: None Quantity: Total = 455 systems Lot/code info: Catalog Number: SR0930CS UDI Code: (01)00811311020492(17)211130(10)17917092 Lot Number: 17917092 Catalog Number: SR0930CS UDI Code: (01)00811311020492(17)211231(10)17923717 Lot Number: 17923717 Catalog Number: SR1030CS UDI Code: (01)00811311020522(17)220131(10)17929776 Lot Number: 17929776 Catalog Number: SR1040CS UDI Code: (01)00811311020539(17)220131(10)17931107 Lot Number: 17931107 Catalog Number: SR0940CS UDI Code: (01)00811311020508(17)230131(10)301576 Lot Number: 301576

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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