SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.0 30o, .070", REF SA6MAC3030. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 48 units of the Sherpa NX Active Guiding Catheter, 6F MAC3.0 30°, model REF SA6MAC3030, a cardiovascular device distributed worldwide. The recall was initiated 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 affected product has GTIN 00613994821737 and includes all lot and serial numbers.
The recalled catheters were distributed to hospitals and medical facilities in the United States and 24 other countries including Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, and the United Kingdom, among others. The source document does not specify what consumers or patients who have received this device should do in response to the 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: 48 units Lot/code info: GTIN: 00613994821737 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.