SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 10 units of the Sherpa NX Active Guiding Catheter, 6F model (reference number SA6PK1W, 47cm length, 070" diameter) distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, and the United Kingdom. The recall was initiated because a subset of these 6F catheters may experience extensive loss of the outer material layer, which could expose the underlying stainless-steel braid wires underneath.
The affected product can be identified by GTIN 00613994823007, and all lot and serial numbers of this model are included in the recall. The source document 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: 10 units Lot/code info: GTIN: 00613994823007 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.