SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0 SH, .070", REF SA6RBU40SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling the Sherpa NX Active Guiding Catheter, 6F RBU4.0 SH model (.070"), used in cardiovascular procedures. The recall affects 30 units distributed worldwide to countries including the US, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, and others. The product has a potential defect where the outer material may wear away extensively on a subset of these catheters, which could expose the underlying stainless-steel braid wires beneath the surface.
The recall covers all lot and serial numbers of this product (GTIN: 00613994822956). The source document does not specify what affected consumers should do in response to 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: 30 units Lot/code info: GTIN: 00613994822956 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.