SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0 SH, .070", REF SA6EBU50SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling Sherpa NX Active Guiding Catheter model 6F EBU5.0 SH, .070" (Reference SA6EBU50SH) due to a potential defect affecting a small subset of units. The problem involves possible extensive loss of the primary segment material, which could expose underlying stainless-steel braid wires. Nine units have been distributed worldwide to countries including the United States, Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Taiwan, United Kingdom, and several others.
The recall notice does not specify a remedy 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: 9 units Lot/code info: GTIN: 00613994824592 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.