SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5, .070", REF SA6JL45. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 237 units of Sherpa NX Active Guiding Catheter, 6F JL4.5 model (reference number SA6JL45), which is a medical device used in cardiovascular procedures. The devices were distributed worldwide to numerous countries including the US, Austria, Belgium, France, Germany, Italy, Spain, and others. The recall affects all lot and serial numbers of this product.
The reason for the recall is that some of these catheters may experience extensive loss of the outer material layer, which could expose the underlying stainless-steel braid wires. The recall notice does not specify a remedy or what affected consumers should do.
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: 237 units Lot/code info: GTIN: 00613994822093 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.