SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII, .070", REF SA6HSII. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling the Sherpa NX Active Guiding Catheter, 6F HSII, .070" (model SA6HSII), a cardiovascular device used in medical procedures. The recall affects 82 units distributed worldwide, including locations in the United States and multiple European, Asian, Middle Eastern, and African countries. The problem involves a potential loss of material from the outer coating of the catheter on some units, which could expose the underlying stainless-steel wires beneath.
The record does not specify what actions affected consumers or patients should take in response to this recall.
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: 82 units Lot/code info: GTIN: 00613994824165 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.