SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5, .070", REF SA6CHAMP15. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 23 units of the Sherpa NX Active Guiding Catheter, 6F CHAMP1.5, .070" (Reference SA6CHAMP15), a cardiovascular device that was distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, and the United Kingdom. The recall was initiated because there is a potential for extensive loss of primary segment material on a subset of these catheters, which could expose 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: 23 units Lot/code info: GTIN: 00613994823397 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.