SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.5 SH, .070", REF SA6MAC35SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 57 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC3.5 SH, .070" (catalog reference SA6MAC35SH), a cardiovascular device. The recalled devices have a potential defect where the outer material coating the primary segment may extensively wear away, which could expose the underlying stainless-steel braid wires inside the catheter. The product was distributed worldwide, including to the United States and numerous countries in Europe, Asia, the Middle East, and Africa.
The recall affects all lot and serial numbers of this specific product model (GTIN: 00613994822055). The source document does not specify a remedy or recommended action for affected consumers.
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: 57 units Lot/code info: GTIN: 00613994822055 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.