SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5, .070", REF SA6SCR35. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 45 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR3.5, .070" (reference SA6SCR35) used for cardiovascular procedures. The recalled catheters, which were distributed worldwide to 25 countries including the United States, Austria, Belgium, France, Germany, and others, may have extensive loss of primary segment material that exposes underlying stainless-steel braid wires.
The recall affects all lot and serial numbers of this product identified by GTIN 00613994822611. The source document does not specify what affected consumers 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: 45 units Lot/code info: GTIN: 00613994822611 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.