SHERPA NX ACTIVE GUIDING CATHETER, 6F MP2, .070", REF SA6MP2. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling Sherpa NX Active Guiding Catheters (6F MP2, .070", model SA6MP2) used in cardiovascular procedures. The recall affects 62 units worldwide that were distributed to countries including the United States, Austria, Belgium, France, Germany, Italy, Spain, and others. The catheters have a potential defect where the outer material may extensively deteriorate, which could expose underlying stainless-steel braid wires.
This defect poses a risk during medical procedures using these catheters. The recall involves all lot and serial numbers of this product (GTIN: 00613994822468). The source document does not specify what remedy affected consumers should pursue.
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: 62 units Lot/code info: GTIN: 00613994822468 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.