SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0, .070", REF SA6SCR40. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 45 units of the Sherpa NX Active Guiding Catheter, 6F SCR4.0, .070" (Reference SA6SCR40) used in cardiovascular procedures. The devices were distributed worldwide to customers in the US and multiple international locations. The recall was issued because a subset of the 6F Sherpa catheters have the potential to lose extensive primary segment material, which could expose underlying stainless-steel braid wires.
The recall notice does not specify a remedy or instructions for what affected consumers should do.
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: 45 units Lot/code info: GTIN: 00613994822598 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.