SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070", REF SA6IMASHJ. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 2 units of the Sherpa NX Active Guiding Catheter, 6F, IMA SH, 60CM, 070" (Reference SA6IMASHJ), a cardiovascular device distributed worldwide. The recall affects all lot and serial numbers of this product due to a potential hazard where the outer material on a subset of these catheters may extensively deteriorate, exposing the underlying stainless-steel braid wires underneath.
The product was distributed to hospitals and medical facilities in the United States and 24 other countries across Europe, Asia, the Middle East, and Africa. The recall documentation does not specify what action affected consumers or healthcare facilities should take regarding this product.
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: 00613994824424 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.