SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0, .070", REF SA6JR30. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 102 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0, .070" (Reference SA6JR30) distributed worldwide to multiple countries including the United States, Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, the United Kingdom, and others. The catheters are used for cardiovascular procedures.
The recall was initiated because a subset of the 6F Sherpa catheters may experience extensive loss of primary segment material, which could expose the underlying stainless-steel braid wires. The source document does not specify a remedy or instructions 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: 102 units Lot/code info: GTIN: 00613994822413 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.