SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL4.0, .070", REF SA6JCL40. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 52 units of its SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL4.0, .070" (Reference SA6JCL40), a cardiovascular device that was distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, the Netherlands, Spain, the United Kingdom, and others. The catheters pose a potential hazard where the outer material may extensively wear away, exposing the underlying stainless-steel braid wires beneath.
The recalled products include all lot and serial numbers of this device model (GTIN: 00613994824363). The recall notice does not specify a remedy or describe 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: 52 units Lot/code info: GTIN: 00613994824363 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.