SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070", REF SA6RRAD. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 113 units of the Sherpa NX Active Guiding Catheter, 6F RRAD, .070" (model SA6RRAD) used in cardiovascular procedures. The catheters were distributed worldwide to 25 countries including the United States, Austria, Belgium, France, Germany, Italy, Spain, and the United Kingdom. The recall was issued because a subset of these 6F catheters have a potential for extensive loss of the primary segment material, which could expose underlying stainless-steel braid wires.
The recall notice does not specify a remedy or recommended 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: 113 units Lot/code info: GTIN: 00613994823205 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.