SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling SHERPA NX ACTIVE Guiding Catheters (6F model, RCB SH, 90CM, 070") distributed worldwide. The recalled devices have a potential defect where the outer material layer may wear away extensively, exposing the underlying stainless-steel braid wires. Two units are affected across all lot and serial numbers bearing GTIN 00613994823267.
The devices were distributed to hospitals and medical facilities in the United States and 24 other countries including Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom. The source document 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: 2 units Lot/code info: GTIN: 00613994823267 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.