SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5, .070", REF SA6JR45. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 90 units of Sherpa NX Active Guiding Catheter, 6F JR4.5, .070" (model SA6JR45) worldwide. The catheters were distributed to the United States and 24 other countries. The devices are used for cardiovascular procedures and have been identified as potentially having extensive loss of primary segment material that could expose underlying stainless-steel braid wires on a subset of the 6F catheters.
The recall affects all lot and serial numbers of this product, identified by GTIN 00613994821829. The source record does not specify what actions affected consumers should take regarding 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: 90 units Lot/code info: GTIN: 00613994821829 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.