SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 172 units of the Sherpa NX Active Guiding Catheter (6F, RBU3.5, 100CM, 070", REF SA6RBU35) used in cardiovascular procedures. The recall affects catheters distributed worldwide to multiple countries including the United States, European nations, and others. The issue involves a potential defect where the outer material covering the primary segment of these catheters may deteriorate extensively, which could expose the underlying stainless-steel braid wires.
The recall notice does not specify a remedy, repair, replacement, or other course of action for affected consumers or healthcare facilities.
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: 172 units Lot/code info: GTIN: 00613994822987 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.