SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 538 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070" (REF SA63DRC) distributed worldwide to 25 countries including the US, Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, and United Kingdom. The catheter is used for cardiovascular procedures. The recall was issued because there is a potential for extensive loss of primary segment material that could expose underlying stainless-steel braid wires on a subset of the 6F Sherpa catheters.
The recalled product includes all lot and serial numbers with GTIN 00613994823823. The recall notice does not specify a remedy or recommended action for consumers who may have received this product.
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: 538 units Lot/code info: GTIN: 00613994823823 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.