FDA (Devices) recall action 82525
The FDA (Devices) publishes a recall like this one as 191 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 191 pages.
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic Vascular is recalling 746 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 26 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 6 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 69 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 42 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 2 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter because of a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling six units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 52 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 4 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 14 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 2,607 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 3,302 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling specific 6F Sherpa NX Active Guiding Catheters due to a potential loss of material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 113 units of Sherpa NX Active Guiding Catheters due to a potential loss of material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 48 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 2 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 12 units of the SHERPA NX ACTIVE GUIDING CATHETER because a subset may experience extensive loss of primary segment material, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 32,484 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 80 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 62 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of segment material that could expose underlying stainless-steel braid wires.