SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5 SH, .070", REF SA6CHAMP15SH. 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 CHAMP1.5 SH, .070" (Reference SA6CHAMP15SH), a cardiovascular device used in medical procedures. The recall affects 29 units with GTIN 00613994823373 across all lot and serial numbers. The problem involves a potential for extensive loss of the catheter's outer material, which could expose underlying stainless-steel braid wires. The affected devices were distributed worldwide to hospitals and medical facilities in the United States and 24 other countries including Austria, Belgium, France, Germany, Italy, Spain, and the United Kingdom.
The record does not specify a remedy or instructions 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: 29 units Lot/code info: GTIN: 00613994823373 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.