SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0, 100CM.070", REF SA6FL40. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 20 units of the Sherpa NX Active Guiding Catheter, 6F, FL4.0, 100CM.070" (Reference SA6FL40) distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, and the United Kingdom, among others. The catheter is used for cardiovascular procedures and is identified by GTIN 00613994824660 across all lot and serial numbers affected by this recall.
The recall was initiated because a subset of these 6F Sherpa catheters has the potential for extensive loss of primary segment material, which could expose the underlying stainless-steel braid wires. The recall notice does not specify a remedy or instructions for what affected consumers should do.
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: 20 units Lot/code info: GTIN: 00613994824660 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.