SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0 SH, .070", REF SA6SCR40SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling Sherpa NX Active Guiding Catheters (model 6F SCR4.0 SH, .070", REF SA6SCR40SH) used in cardiovascular procedures. The catheters have a potential defect where the outer material may extensively wear away, exposing the underlying stainless-steel braid wires underneath. This recall affects devices distributed worldwide, including locations in the United States and multiple countries across Europe, Asia, the Middle East, and Africa.
The recall notice does not specify a remedy or instructions for what consumers should do with affected devices.
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: N/A Lot/code info: GTIN: 00613994822574 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.