SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 17 units of Sherpa NX Active Guiding Catheters (6F, EBU4.0, 110CM.070", model SA6EBU40A) used in cardiovascular procedures. The catheters have a potential defect where the outer material may wear away extensively, which could expose underlying stainless-steel braid wires. The affected devices were distributed worldwide to numerous countries including the United States, European nations, and parts of Asia and the Middle East.
The recall notice does not specify a remedy or instructions 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: 17 units Lot/code info: GTIN: 00613994823519 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.