FDAMarch 23, 2022device
Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM04025013P ADM05004013P ADM05004013P ADM05006013P ADM05006013P ADM05008013P ADM050080...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
What to do
FDA enforcement status: Ongoing
Brands named
medtronic vascularmedtronic
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMedtronic O-arm O2 Imaging System. Model Number: BI70002000.2026-05-19
- FDAMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAMedtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
- FDAOctopus 4 Tissue Stabilizer, Model 294002026-05-12
- FDAMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter2026-04-21
- FDAMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter2026-04-21
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