Medtronic Ireland
FDA adverse event reports naming Medtronic Ireland as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: Medtronic Ireland.
- Total reports
- 1,203
- Deaths
- 44
- Injuries
- 563
- Malfunctions
- 595
Top device categories
- Leadless PacemakerPNJ442
- Aortic Valve, Prosthesis, Percutaneously DeliveredNPT146
- System, Endovascular Graft, Aortic Aneurysm TreatmentMIH135
- Coronary Drug-Eluting StentNIQ134
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationQZI107
- Catheter, SteerableDRA67
- Catheter, PercutaneousDQY63
- Drug-Eluting Peripheral Transluminal Angioplasty CatheterONU44
- Drug-Coated Peripheral Transluminal Angioplasty CatheterPRC12
- Endovascular Suturing SystemOTD11
Recent recalls
- 2020-05-27TerminatedProcess control
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
- 2017-09-20TerminatedProcess design
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Stylette removal difficulties on the Euphora and Solarice products.
- 2017-09-20TerminatedProcess design
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Stylette removal difficulties on the Euphora and Solarice products.
- Open, ClassifiedUnder Investigation by firm
Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
- Open, ClassifiedUnder Investigation by firm
Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
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