Open PivotRecalls & reported problems across all models
Medtronic, Inc. · 42 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 122
- Deaths reported
- 11
- Injuries reported
- 110
- Recalls
- 0
We found 42 models of Open Pivot by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 122 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2016 and Sep 23, 2026 — classified as 11 deaths, 110 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (74 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Open Pivot problems
Device problems
- Insufficient Device Problem Information74
- Patient Device Interaction Problem20
- Adverse Event Without Identified Device or Use Problem19
- Inadequacy of Device Shape and/or Size15
- Perivalvular Leak6
- Device Stenosis5
- Incomplete Coaptation4
- Gradient Increase3
Patient problems
- Insufficient Information39
- No Information34
- Non specific EKG/ECG Changes10
- Heart Block8
- Thrombosis/Thrombus7
- Aortic Valve Stenosis5
- Death5
- Low Blood Pressure/ Hypotension4
Open Pivot models
42 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Open Pivot™ 505DA20HEART-VALVE, MECHANICAL1 death13 reports
- Open Pivot™ 500DM29HEART-VALVE, MECHANICAL11 reports
- Open Pivot™ 505DA24HEART-VALVE, MECHANICAL1 death9 reports
- Open Pivot™ 500DM27HEART-VALVE, MECHANICAL1 death8 reports
- Open Pivot™ 505DA18HEART-VALVE, MECHANICAL7 reports
- Open Pivot™ 505DA20HEART-VALVE, MECHANICAL5 reports
- Open Pivot™ 505DA22HEART-VALVE, MECHANICAL5 reports
- Open Pivot™ 500DM33HEART-VALVE, MECHANICAL1 death5 reports
- Open Pivot™ 505DA22HEART-VALVE, MECHANICAL5 reports
- Open Pivot™ 500DM25HEART-VALVE, MECHANICAL1 death5 reports
- Open Pivot™ 500DM27HEART-VALVE, MECHANICAL4 reports
- Open Pivot™ 505DM26HEART-VALVE, MECHANICAL2 deaths4 reports
- Open Pivot™ 500DM31HEART-VALVE, MECHANICAL3 reports
- Open Pivot™ 500DM33HEART-VALVE, MECHANICAL2 reports
- Open Pivot™ 500DM29HEART-VALVE, MECHANICAL2 reports
- Open Pivot™ 500DM33HEART-VALVE, MECHANICAL2 reports
- Open Pivot™ 501DM24HEART-VALVE, MECHANICAL1 death2 reports
- Open Pivot™ 505DA26HEART-VALVE, MECHANICAL2 reports
- Open Pivot™ 505DA16HEART-VALVE, MECHANICAL1 death2 reports
- Open Pivot™ 500DM31HEART-VALVE, MECHANICAL2 reports
- Open Pivot™ 505DA20HEART-VALVE, MECHANICAL1 death2 reports
- Open Pivot™ 500DM27HEART-VALVE, MECHANICAL2 reports
- Open Pivot™ 500FA21HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 500FA23HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 500DM25HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 505DA16HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 505DA20HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 505DA22HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 500DM27HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 505DA16HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 500DM27HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 500DM31HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 500DM25HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 500DM29HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 500DM31HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 502AG25HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 502AG27HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 501DM26HEART-VALVE, MECHANICAL1 death1 report
- Open Pivot™ 500FA21HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 500FA23HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 500FA27HEART-VALVE, MECHANICAL1 report
- Open Pivot™ 500DM29HEART-VALVE, MECHANICAL1 report
Recent Open Pivot adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Patient Device Interaction Problem
It was reported that 3 years and 4 months post implant of this 22mm aortic open pivot valve, a permanent pacemaker was implanted. The reason for the permanent pacemaker was reported as complete heart block (CHB) and atrial arrythmias (atrial tachycardia (AT), atrial fibrillation (AF) and atrial flutter (A-Fl). No additional adverse patient effects were reported.
Patient problems: Atrial Fibrillation; Atrial Flutter; Heart Block; Tachycardia
MAUDE report 50867293 ↗InjuryApr 27, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 12 YEARS AND 1 MONTH POST IMPLANT OF THIS 27MM TRICUSPID MECHANICAL VALVE AND 31MM MITRAL MECHANICAL VALVE, A LEADLESS PACEMAKER WAS IMPLANTED. THE REASON FOR THE LEADLESS PACEMAKER WAS REPORTED AS ATRIOVENTRICULAR BLOCK (AVB) (MOBITZ II). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 24999623 ↗InjuryApr 27, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 12 YEARS AND 1 MONTH POST IMPLANT OF THIS 27MM TRICUSPID MECHANICAL VALVE AND 31MM MITRAL MECHANICAL VALVE, A LEADLESS PACEMAKER WAS IMPLANTED. THE REASON FOR THE LEADLESS PACEMAKER WAS REPORTED AS ATRIOVENTRICULAR BLOCK (AVB) (MOBITZ II). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 24999620 ↗InjuryApr 1, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 18MM AORTIC MECHANICAL VALVE AND 29MM MITRAL MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Bradycardia
MAUDE report 24752912 ↗InjuryApr 1, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 18MM AORTIC MECHANICAL VALVE AND 29MM MITRAL MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Bradycardia
MAUDE report 24752848 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 5 YEARS POST IMPLANT OF THIS 23MM AORTIC MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 21MM AORTIC MECHANICAL VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 23654463 ↗InjuryNov 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT 2 DAYS POST IMPLANT OF THIS 24MM AORTIC MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Heart Block
MAUDE report 23494813 ↗InjuryNov 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS 24MM AORTIC MECHANICAL HEART VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM AORTIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 23474473 ↗InjuryOct 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST-IMPLANT OF THIS 33MM MITRAL MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Heart Block
MAUDE report 23380337 ↗InjuryMay 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 6 MONTHS POST IMPLANT OF THIS 29MM MITRAL MECHANICAL VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS REPORTED AS PRIMARY PREVENTION AND CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 22010845 ↗InjuryMay 13, 2025Insufficient Device Problem Information; Thickening of Material; Device Stenosis; Insufficient Device Problem Information; Thickening of Material; Device Stenosis
ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS AORTIC STENOSIS DUE TO PANNUS FORMATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Stenosis; Foreign Body Reaction; Insufficient Information
MAUDE report 22009985 ↗InjuryMay 6, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis
IT WAS REPORTED THAT POST IMPLANT OF THIS 22MM AORTIC MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AVALUS VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Stenosis; Insufficient Information; Thrombosis/Thrombus
MAUDE report 21967618 ↗InjuryApr 28, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS SEVERE MITRAL STENOSIS. IT WAS STATED THAT THE MITRAL VALVE WAS THROMBOSED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information; Mitral Valve Stenosis; Thrombosis/Thrombus
MAUDE report 21917042 ↗InjuryFeb 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 27MM MITRAL MECHANICAL VALVE AND 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS 25MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEIZURE ACTIVITY AND A STROKE. A COMPUTED TOMOGRAPHY (CT) OF THE HEAD DEMONSTRATED NO ACUTE PROCESS. AN ELECTROENCEPHALOGRAPHY SHOWED STATUS EPILEPTICUS AND A ANTI-EPILEPTIC DRUG WAS ADMINISTERED. IT WAS STATED THAT THE COMPUTED TOMOGRAPHY (CT) SHOWED THE PRESENCE OF A RIGHT M2 BRANCH OCCLUSION, A RELATIVELY SMALL BRANCH DISTAL TO A TRIFURCATION OF THE MIDDLE CEREBRAL ARTERY (MCA), WITH IMMEDIATE DISTAL RECONSTITUTION AND SHOWED A REGION OF MODERATE STENOSIS OF RIGHT M2 BRANCHES WITH POST-STENOTIC DILATATION. AN MAGNETIC RESONANCE IMAGING (MRI) OF THE HEAD WAS OBTAINED THE FOLLOWING DAY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Convulsion/Seizure; Stroke/CVA
MAUDE report 21433222 ↗InjuryNov 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT POST IMPLANT OF THIS 20 MM MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT P ACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Heart Block
MAUDE report 20783059 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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