SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI SH, 100CM, 070", REF SA6HSISH . for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 14 units of the Sherpa NX Active Guiding Catheter, 6F model (Reference SA6HSISH, 100CM, 070") due to a potential defect in which the outer material layer may deteriorate extensively, exposing the underlying stainless-steel braid wires. The affected catheters were distributed worldwide to medical facilities in the United States and 24 other countries.
The recall notice does not specify a remedy or corrective action for affected consumers to undertake.
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: 14 units Lot/code info: GTIN: 00613994824127 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.