SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0 SH, .070", REF SA6JR30SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 51 units of the Sherpa NX Active Guiding Catheter, 6F JR3.0 SH model, which is used in cardiovascular procedures. The recall affects devices with GTIN 00613994822406 across all lot and serial numbers that were distributed worldwide to countries including the United States, Austria, Belgium, France, Germany, Italy, Spain, and others. The problem is that a subset of these catheters has the potential for extensive loss of the primary segment material, which could expose underlying stainless-steel braid wires.
The exposed stainless-steel braid wires pose a risk during cardiovascular use. The recall record does not specify what action affected consumers or healthcare facilities should take regarding the recalled devices.
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: 51 units Lot/code info: GTIN: 00613994822406 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.