SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB, .070", REF SA6LCB. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 305 units of Sherpa NX Active Guiding Catheter, 6F LCB, .070" (model SA6LCB) distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, and others. The catheters have a potential defect where the outer material could extensively wear away, exposing the underlying stainless-steel braid wires underneath.
The affected product has GTIN 00613994821713 and includes all lot and serial numbers of this model. The recall record does not specify what actions affected consumers or healthcare facilities should take.
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: 305 units Lot/code info: GTIN: 00613994821713 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.