SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 49 units of the Sherpa NX Active Guiding Catheter, 6F JL3.0 SH model (.070") used in cardiovascular procedures. The catheter has a potential defect where the outer material layer may extensively wear away, which could expose the underlying stainless-steel braid wires underneath. This catheter was distributed worldwide to multiple countries including the United States, Austria, Belgium, France, Germany, Italy, Spain, the United Kingdom, and others.
The recall affects all lot and serial numbers of this product model (GTIN: 00613994822253). The source document does not specify what consumers or healthcare providers should do regarding this recall.
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: 49 units Lot/code info: GTIN: 00613994822253 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.