FDA (Devices) recall action 77144
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
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 is recalling 478,465 units of the Pacemaker Angio X3 because an incomplete seal on the inner package may cause the suture material to degrade prematurely.
Medtronic is recalling specific Endo Stitch Polysorb sutures because an incomplete inner package seal may cause the material to degrade prematurely.
Medtronic is recalling specific Polysorb suture products because an incomplete inner package seal may cause the suture material to degrade prematurely.
Medtronic is recalling custom suture packs because an incomplete inner package seal may cause the suture material to degrade prematurely.
Medtronic is recalling BIOSYN sutures because an incomplete inner package seal may cause the suture material to degrade prematurely.
Medtronic is recalling Best Practice Kits because an incomplete seal may cause the suture material to degrade prematurely.
Medtronic is recalling specific MAXON sutures because an incomplete inner package seal may cause the suture material to degrade prematurely.
Medtronic is recalling USPACK-SUTURE KITs (Item US1672) because an incomplete inner package seal may cause the suture material to degrade prematurely.