SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5 SH, .070", REF SA6AL15SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular has recalled 40 units of the Sherpa NX Active Guiding Catheter, 6F AL1.5 SH, .070" (Reference SA6AL15SH) used in cardiovascular procedures. The recalled devices were distributed worldwide to 25 countries including the United States, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, and others. The recall was initiated because a subset of these 6F Sherpa catheters has the potential to lose extensive amounts of primary segment material, which could expose underlying stainless-steel braid wires.
The affected devices have GTIN 00613994823748 and include all lot and serial numbers of this product. The recall document does not specify a remedy or recommended action for consumers or healthcare providers who may have received affected units.
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: 40 units Lot/code info: GTIN: 00613994823748 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.