SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.0 SH, .070", REF SA6SAL10SH. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic Vascular is recalling 27 units of the Sherpa NX Active Guiding Catheter, 6F SAL1.0 SH, .070" (Reference SA6SAL10SH) worldwide. The catheters are used in cardiovascular procedures. A subset of these devices has a potential defect where the outer material coating may extensively wear away, which could expose the underlying stainless-steel braid wires beneath.
The recalled devices were distributed to multiple countries including the United States, various European nations, Hong Kong, Saudi Arabia, South Africa, Taiwan, and the United Kingdom. The recall affects all lot and serial numbers of this product (GTIN: 00613994823182). The source document does not specify a remedy or 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: 27 units Lot/code info: GTIN: 00613994823182 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.