SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5 SH, .070", REF SA6JR45SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 62 units of the Sherpa NX Active Guiding Catheter, 6F JR4.5 SH model, used in cardiovascular procedures. The recalled catheters may experience extensive loss of the outer material layer, which could expose the underlying stainless-steel braid wires. These devices were distributed worldwide, including to the United States and numerous European and other countries.
The recall notice does not specify a remedy or recommend any corrective 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: 62 units Lot/code info: GTIN: 00613994821812 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.