SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 .070", REF SA6MAC30. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 206 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 .070" (Reference SA6MAC30) used in cardiovascular procedures worldwide. The recalled catheters may experience extensive loss of the outer material layer, which could expose underlying stainless-steel braid wires. This defect affects all lot and serial numbers of this product model.
The affected devices were distributed to hospitals and medical facilities in the United States and 24 other countries. The recall notice does not specify a remedy, corrective action, or what affected consumers should do 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: 206 units Lot/code info: GTIN: 00613994821720 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.