SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 167 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070" (Reference SA6ERADL), a cardiovascular device that was distributed worldwide to 25 countries including the United States, Austria, Belgium, France, Germany, and others. 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 affected devices have GTIN 00613994824769 and include all lot and serial numbers for this model. The source document does not specify a remedy for affected consumers or what actions they should take regarding this recall.
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: 167 units Lot/code info: GTIN: 00613994824769 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.