SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 5 units of the SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070" (Reference SA6SAL30), a cardiovascular device. The recalled product has the GTIN 00613994823113 and includes all lot and serial numbers. The hazard involves a potential for extensive loss of primary segment material that could expose underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
The recalled devices were distributed worldwide, including to the United States and 24 other countries in Europe, Asia, Africa, and the Middle East. According to the recall record, no remedy has been specified 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: 5 units Lot/code info: GTIN: 00613994823113 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.