SHERPA NX ACTIVE GUIDING CATHETER, 6F, LCB SH, 90CM, 070", REF SA6LCBSHD. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular has recalled the Sherpa NX Active Guiding Catheter (6F, LCB SH, 90CM, 070", REF SA6LCBSHD), a device used in cardiovascular procedures. A subset of these 6F Sherpa catheters has the potential to experience extensive loss of primary segment material, which could expose underlying stainless-steel braid wires. Two units with GTIN 00613994821676 and all lot and serial numbers are affected.
The product was distributed worldwide, including to the United States and 25 other countries. The recall notice does not specify what actions affected consumers or healthcare providers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Reason for recall: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters. Distribution: Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom Quantity: 2 units Lot/code info: GTIN: 00613994821676 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.