SHERPA NX ACTIVE GUIDING CATHETER, 6F FR3.5, .070", REF SA6FR35. 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 FR3.5, .070" (model SA6FR35) used in cardiovascular procedures. The catheter has a potential defect where the outer material layer may extensively deteriorate, exposing the underlying stainless-steel braid wires underneath. The affected devices were distributed worldwide, including to the United States and multiple European, Middle Eastern, Asian, and African countries.
The recall notice does not specify a remedy or corrective action for affected consumers to 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: 00613994824202 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.