SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL355. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 80 units of SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070" (Reference SA6JL355) that were distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, and others. The catheters are used for cardiovascular procedures and have the GTIN 20613994822233 across all lot and serial numbers.
The recall was initiated because a subset of these 6F Sherpa catheters has the potential for extensive loss of primary segment material, which could expose underlying stainless-steel braid wires. The recall record 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: 80 units Lot/code info: GTIN: 20613994822233 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.