SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 6,219 units of SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070" (Reference SA6JL35) used in cardiovascular procedures. The catheters were distributed worldwide to the United States and 24 other countries. The recall was issued because a subset of these 6F Sherpa catheters has the potential to lose extensive amounts of their primary segment material, which could expose the underlying stainless-steel braid wires.
The recall affects all lot and serial numbers of this product model (GTIN: 00613994822246). The source document does not specify a remedy or instructions 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: 6219 units Lot/code info: GTIN:00613994822246 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.