SHERPA NX ACTIVE GUIDING CATHETER, 6F MB2 SH, .070", REF SA6MB2SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling Sherpa NX Active Guiding Catheters, model 6F MB2 SH .070" (Reference SA6MB2SH), used in cardiovascular procedures. The recall affects 18 units that were distributed worldwide, including to the US and multiple European, Middle Eastern, African, and Asian countries. The catheters have a potential defect where the outer material coating may extensively deteriorate, which could expose the underlying stainless-steel braid wires.
This defect could create safety concerns during cardiovascular procedures. The recall covers all lot and serial numbers of this specific catheter model (GTIN: 00613994821911). The source document does not specify what action affected consumers or healthcare facilities 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: 18 units Lot/code info: GTIN: 00613994821911 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.