SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling the SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20 (Reference SA6AL20A), a device used in cardiovascular procedures. The recall affects 3 units that were distributed worldwide, including to the United States and multiple countries in Europe and Asia. The problem involves a potential loss of the catheter's outer material layer that could expose underlying stainless-steel braid wires on a subset of these 6F catheters.
The recall applies to all lot and serial numbers of this product (GTIN: 00613994823724). The source document does not specify a remedy or corrective action for affected consumers.
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: 3 units Lot/code info: GTIN: 00613994823724 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.