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 6F Sherpa NX Active Guiding Catheters because a potential loss of primary segment material may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 339 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 specific 6F Sherpa NX Active Guiding Catheters because a defect may cause material loss, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 215 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 496 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 406 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 11 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing stainless-steel braid wires.
Medtronic Vascular is recalling 1,364 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 614 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 10 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 11 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 159 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing stainless-steel braid wires.
Medtronic Vascular is recalling 8 units of Sherpa NX Active Guiding Catheters due to 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 because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying wires.
Medtronic Vascular is recalling 2 units of Sherpa NX Active Guiding Catheters due to potential loss of segment material exposing stainless-steel wires.