SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.5, .070", REF SA6RBU45. 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 RBU4.5, .070") used in cardiovascular procedures. The catheters have a potential defect where the outer material layer may extensively deteriorate, exposing underlying stainless-steel braid wires. This defect affects six units that 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 or healthcare providers.
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: 00613994822932 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.