SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU35. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 32,484 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070" (Reference SA6EBU35) used in cardiovascular procedures. The recall affects all lot and serial numbers of this product. The catheter has a potential defect where the outer material may extensively deteriorate on certain units, which could expose underlying stainless-steel braid wires.
The affected catheters were distributed worldwide, including to the United States and 24 other countries across Europe, Asia, the Middle East, and Africa. The recall document does not specify a remedy or instructions for affected consumers to follow.
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: 32484 units Lot/code info: GTIN:00613994823595 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.