SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII SH, .070", REF SA6HSIISH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 14 units of the Sherpa NX Active Guiding Catheter, 6F HSII SH, .070" (REF SA6HSIISH), a cardiovascular device distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, and the United Kingdom. The recall was issued due to a potential defect where the primary segment material on a subset of these catheters could extensively deteriorate, which would expose the underlying stainless-steel braid wires.
The recall record does not specify a remedy or recommended course of 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: 14 units Lot/code info: GTIN: 00613994824134 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.