SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 90CM, 070", REF SA6IMAD . for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 53 units of the Sherpa NX Active Guiding Catheter, 6F, IMA, 90CM, 070" (Reference SA6IMAD), a cardiovascular device. The recalled units have a potential defect where the primary segment material may extensively deteriorate, which could expose the underlying stainless-steel braid wires. The affected devices were distributed worldwide to hospitals and medical facilities in the United States and 24 other countries.
The recall notice does not specify a remedy or what affected consumers should do 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: 53 units Lot/code info: GTIN: 00613994824066 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.