SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 1,479 units of the Sherpa NX Active Guiding Catheter, model 6F AL.75, .070" (Reference SA6AL75), a cardiovascular device distributed worldwide. The recall affects all lot and serial numbers of this product, which was distributed to the United States and 24 other countries including Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, Sweden, and the United Kingdom, among others.
The recall was initiated because a subset of the 6F Sherpa catheters has a potential defect where the primary segment material can be extensively lost, which would expose the underlying stainless-steel braid wires. The recall record does not specify a remedy or recommended action 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: 1479 units Lot/code info: GTIN: 00613994823977 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.