SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF SA6IMASH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 42 units of the Sherpa NX Active Guiding Catheter, 6F, IMA SH, 100CM, 070" (reference number SA6IMASH) used in cardiovascular procedures. The recall affects units with GTIN 00613994824042 across all lot and serial numbers. The catheter has a potential defect where the outer material layer may wear away extensively, which could expose the underlying stainless-steel braid wires inside the device.
The recalled catheters were distributed worldwide to 25 countries and regions, including the United States, various European nations, Hong Kong, Saudi Arabia, South Africa, and Taiwan. The product recall record does not specify a remedy or recommended course of 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: 42 units Lot/code info: GTIN: 00613994824042 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.