SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 5 units of the Sherpa NX Active Guiding Catheter, 6F CHAMP3.5 model used in cardiovascular procedures. The recalled catheters have a potential defect where the outer coating material may wear away extensively, which could expose underlying stainless-steel wire braid underneath. The affected devices were distributed worldwide, including to the United States and multiple countries in Europe, Asia, and Africa.
The recall notice does not specify what actions consumers or patients should take in response to this recall.
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: 5 units Lot/code info: GTIN: 00613994823663 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.