SHERPA NX ACTIVE GUIDING CATHETER, 6F JL6.0 SH, .070", REF SA6JL60SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 37 units of the Sherpa NX Active Guiding Catheter (6F JL6.0 SH, .070", Reference SA6JL60SH) distributed worldwide to multiple countries including the United States, Austria, Belgium, France, Germany, and others. The catheter is used for cardiovascular procedures and is affected by a defect in which the outer material coating on some devices may substantially wear away, potentially exposing the underlying stainless-steel braid wires.
The hazard associated with this defect could create risks during medical use of the device. The recall affects all lot and serial numbers of this product model (GTIN: 00613994822420). The source document does not specify a remedy or corrective 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: 37 units Lot/code info: GTIN: 00613994822420 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.