SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL3.5, .070", REF SA6JCL35. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 11 Sherpa NX Active Guiding Catheters (model 6F JCL3.5, .070", Reference SA6JCL35) 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 in cardiovascular procedures. The recall was issued because a subset of these catheters has the potential to lose extensive primary segment material, which could expose underlying stainless-steel braid wires.
The recall notice 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: 11 units Lot/code info: GTIN: 00613994824387 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.