SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0, .070", REF SA6JL50. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 567 units of the Sherpa NX Active Guiding Catheter, 6F JL5.0, .070" (Reference SA6JL50) used in cardiovascular procedures. The catheter has a potential defect where the outer material layer may extensively wear away on some units, which would expose the underlying stainless-steel braid wires. The affected devices were distributed worldwide to hospitals and medical facilities in the United States and 24 other countries.
The recall notice does not specify a remedy or instructions for what affected consumers should do regarding the recalled catheters.
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: 567 units Lot/code info: GTIN: 00613994822079 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.