SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. for cardiovascular use
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 4 units of the Sherpa NX Active Guiding Catheter, 6F, AL1.0 90CM.070" (model SA6AL10D), a device used in cardiovascular procedures. The affected catheters may experience extensive loss of the outer material layer, which could expose the underlying stainless-steel braid wires. This recall affects units that were distributed worldwide, including to the United States and numerous countries across Europe, Asia, the Middle East, and Africa.
The recall notice does not specify a remedy or recommended action for consumers who may have received this product.
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: 4 units Lot/code info: GTIN: 00613994823762 All Lot/Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.