SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5 SH, .070", REF SA6JR35SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 353 units of the Sherpa NX Active Guiding Catheter, 6F JR3.5 SH model (reference number SA6JR35SH), a medical device used in cardiovascular procedures. The recalled catheters were distributed worldwide to 25 countries including the United States, various European nations, and parts of Asia and the Middle East. The recall was initiated because a subset of these catheters has the potential to lose extensive amounts of their primary segment material, which could expose the underlying stainless-steel braid wires beneath.
The recall affects all lot and serial numbers of this product (GTIN: 00613994822352). The source document does not specify what remedy or action affected consumers or healthcare facilities should take regarding the recalled devices.
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: 353 units Lot/code info: GTIN: 00613994822352 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.