SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5, .070" REF SA6SR35. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 6 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5, .070" (REF SA6SR35), a cardiovascular device. The recall affects all lot and serial numbers of this product (GTIN: 00613994822796). The catheter has a potential defect where the outer material coating the primary segment could extensively wear away, which would expose the underlying stainless-steel braid wires underneath.
The affected catheters were distributed worldwide, including to facilities in the United States and numerous countries across Europe, Asia, the Middle East, and Africa. The recall notice does not specify a remedy for consumers or healthcare providers who have received this product.
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: 6 units Lot/code info: GTIN: 00613994822796 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.