SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 1,364 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070" (Reference SA6AL20), a device used in cardiovascular procedures. The recall affects all lot and serial numbers of this product, which were distributed worldwide to the United States and 24 other countries. The hazard involves a potential for extensive loss of the catheter's primary segment material, which could expose the underlying stainless-steel braid wires.
The recall was issued because of this potential material degradation on a subset of the 6F Sherpa catheters. The source document does not specify a remedy or recommended action 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: 1364 units Lot/code info: GTIN: 00613994823731 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.