SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 613,994 units of the Sherpa NX Active Guiding Catheter, 6F LARA, .070" (model SA6LARA), a medical device used in cardiovascular procedures. The recall affects 247 units that were distributed worldwide, including to the United States and numerous other countries in Europe, Asia, the Middle East, and Africa. The reason for the recall is a potential defect in a subset of these catheters where the outer material may extensively deteriorate, which could expose the underlying stainless-steel braid wires inside the device.
The record does not specify a remedy or corrective action for affected consumers or healthcare providers.
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: 247 units Lot/code info: GTIN: 00613994821775 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.