SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 1,226 units of Sherpa NX Active Guiding Catheters (6F, IMA 55CM .070", model SA6IMAK) distributed worldwide to multiple countries including the United States. These catheters are used in cardiovascular procedures. The recall was issued because a subset of the 6F catheters may experience extensive loss of the outer material layer, which could expose the underlying stainless-steel braid wires.
The recall affects all lot and serial numbers of this product (GTIN 00613994824059). The record does not specify a remedy or instructions for what affected consumers should do.
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: 1226 units Lot/code info: GTIN 00613994824059 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.