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 12 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
A subset of SHERPA NX active guiding catheters may expose patients to underlying stainless steel braid wires due to material loss.
Medtronic Vascular is recalling 87 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing 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 two units of the Sherpa NX Active Guiding Catheter due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling six 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 17 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 53 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 34 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 23 units of Sherpa NX Active Guiding Catheters because of a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 121 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 1,495 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 22 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 56 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 163 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 33 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 16 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 143 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 303 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 potential loss of primary segment material exposing 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 219 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Medtronic Vascular is recalling 57 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 488 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Medtronic Vascular is recalling 20 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.