SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII SH, .070", REF SA6HSIIISH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 6 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII SH, .070" (Reference SA6HSIIISH), a cardiovascular device distributed worldwide. The catheter has a potential defect where a subset of units may experience extensive loss of primary segment material, which could expose the underlying stainless-steel braid wires. The affected devices were distributed to the United States and 24 other countries including Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, and the United Kingdom.
The recall affects all lot and serial numbers of this product (GTIN: 00613994824141). The source document does not specify a remedy, required actions for affected consumers, or instructions for what patients or healthcare providers should do regarding devices already in use.
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: 6 units Lot/code info: GTIN: 00613994824141 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.