SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0, .070", REF SA6CHAMP10. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 120 units of the Sherpa NX Active Guiding Catheter, 6F CHAMP1.0, .070" (Reference SA6CHAMP10) used in cardiovascular procedures. The recalled catheters have a defect where the outer material may extensively deteriorate, which could expose the underlying stainless-steel braid wires beneath. The affected units were distributed worldwide to customers in the United States and 24 other countries.
The recall record does not specify a remedy or recommended action for consumers who may have received these catheters.
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: 120 units Lot/code info: GTIN: 00613994823410 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.