SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0 SH, .070", REF SA6JL50SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 56 units of the Sherpa NX Active Guiding Catheter, 6F JL5.0 SH model, distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, Spain, and the United Kingdom. The catheter is used in cardiovascular procedures and has a potential defect where the outer material layer may wear away extensively on some units, which could expose the underlying stainless-steel braid wires.
The recall affects all lot and serial numbers of this model, identified by GTIN 00613994822444. The source document does not specify a remedy or instructions for consumers regarding what they should do if they have received one of these devices.
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: 56 units Lot/code info: GTIN: 00613994822444 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.