SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR1.0, .070", REF SA6SAR10. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling the Sherpa NX Active Guiding Catheter, 6F SAR1.0, .070" (Reference SA6SAR10), a device used in cardiovascular procedures. The recall affects 12 units distributed worldwide to multiple countries including the United States, Austria, Belgium, France, Germany, Italy, Spain, Sweden, and the United Kingdom. The problem involves a potential for extensive loss of primary segment material that could expose underlying stainless-steel braid wires on a subset of the 6F Sherpa catheters.
The affected devices can be identified by GTIN 00613994822659, and all lot and serial numbers of this product are included in the recall. The source document does not specify a remedy or recommended action for consumers who may have received or used this device.
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: 12 units Lot/code info: GTIN: 00613994822659 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.