SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. 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, EBU3.5, 90CM.070" (Reference SA6EBU35D), a cardiovascular device distributed worldwide. The recall affects 2 units across multiple countries including the US, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, the United Kingdom, and others. The product has a potential defect where the outer material layer may extensively deteriorate and expose underlying stainless-steel braid wires.
The recall was initiated because of the risk that the primary segment material could be lost on affected catheters, which could expose the internal wire structure. The source document does not specify a remedy or recommended action for consumers who may have received 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: 2 units Lot/code info: GTIN: 00613994823571 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.