SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070", REF SA6ALR12. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 163 units of the Sherpa NX Active Guiding Catheter, 6F ALR1-2, .070" (Reference SA6ALR12) worldwide. The affected devices were distributed to the United States and 24 other countries. The catheter has a potential defect where the outer material layer may extensively deteriorate, which could expose the underlying stainless-steel braid wires inside the device.
The recall affects all lot and serial numbers of this product (GTIN: 00613994823946). The recall record does not specify what actions affected consumers should take 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: 163 units Lot/code info: GTIN: 00613994823946 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.