SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR5.0, .070", REF SA6SCR50. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 9 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR5.0, .070" (Reference SA6SCR50), a cardiovascular device. The catheters have a potential defect where the outer material may extensively wear away, which could expose the underlying stainless-steel braid wires underneath. The affected devices were distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, and the United Kingdom.
The recall affects all lot and serial numbers of this product, as indicated by the GTIN 00613994822567. The source document does not specify what remedy or action affected consumers should take.
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: 9 units Lot/code info: GTIN: 00613994822567 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.