SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 39 units of the Sherpa NX Active Guiding Catheter (6F, JR4.0, 55CM, 070", REF SA6JR40K) distributed worldwide to multiple countries including the US, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, and others. The catheter is used in cardiovascular procedures. The recall was initiated because some units in this subset have the potential for extensive loss of primary segment material, which could expose underlying stainless-steel braid wires.
The record does not specify a remedy or instructions for affected consumers to follow.
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: 39 units Lot/code info: GTIN: 00613994822291 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.