SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 18 units of the Sherpa NX Active Guiding Catheter, 6F ERAD Right Short Tip model worldwide. The recalled catheters have a potential defect where the outer material layer may extensively wear away or deteriorate, which could expose the underlying stainless-steel wire reinforcement structure beneath the surface.
The affected catheters were distributed to medical facilities across the United States and 24 other countries including Austria, Belgium, France, Germany, Italy, and the United Kingdom. The recall notice does not specify what consumers should do regarding 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: 18 units Lot/code info: GTIN: 00613994824684 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.