SHERPA NX ACTIVE GUIDING CATHETER, 6F RCBII, .070", REF SA6RCBII. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling Sherpa NX Active Guiding Catheters (6F RCBII, .070", Reference SA6RCBII) used in cardiovascular procedures. The recall affects 3 units that were distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, and the United Kingdom. The catheters have a potential defect where the outer material coating may extensively wear away, exposing the underlying stainless-steel braid wires beneath.
The recall notice does not specify what actions affected consumers or healthcare providers should take regarding this product.
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: 3 units Lot/code info: GTIN: 00613994822895 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.