SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 531 units of its Sherpa NX Active Guiding Catheter (6F SL4.0, .070", REF SA6SL40) distributed worldwide. The catheter is used in cardiovascular procedures. The recall was initiated because a subset of these catheters may experience extensive loss of the outer material layer, which could expose the underlying stainless-steel braid wires inside the device.
The recall affects all lot and serial numbers of this product. The source document does not specify what action affected consumers should take 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: 531 units Lot/code info: GTIN: 00613994822499 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.