SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling Sherpa NX Active Guiding Catheter devices (model 6F, CHAMP2.0, 55CM.070", reference SA6CHAMP20K) used in cardiovascular procedures. The recall affects 5 units that were distributed worldwide to countries including the United States, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, and others. The devices may experience extensive loss of outer material that could expose underlying stainless-steel braid wires.
The recall notice 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: 5 units Lot/code info: GTIN: 00613994823359 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.