SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL5.0, 110CM, 070", REF SA6JL50A. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 12 units of the Sherpa NX Active Guiding Catheter (6F, JL5.0, 110CM, 070", REF SA6JL50A) distributed worldwide to multiple countries including the United States, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, and others. The catheter is used in cardiovascular procedures.
The recall was initiated because a subset of these 6F Sherpa catheters may experience extensive loss of primary segment material, which could expose underlying stainless-steel braid wires. The affected product carries GTIN 00613994822451 and includes all lot and serial numbers. The recall record does not specify a remedy or 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: 12 units Lot/code info: GTIN: 00613994822451 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.