HANCOCK II ULTRARecalls & reported problems across all models
Medtronic, Inc. · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 86
- Deaths reported
- 2
- Injuries reported
- 81
- Recalls
- 0
We found 19 models of HANCOCK II ULTRA by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 86 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2017 and Sep 15, 2026 — classified as 2 deaths, 81 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (53 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 HANCOCK II ULTRA problems
Device problems
- Insufficient Device Problem Information53
- Device Stenosis13
- Gradient Increase11
- Intravalvular regurgitation10
- Adverse Event Without Identified Device or Use Problem9
- Patient Device Interaction Problem4
- Perivalvular Leak3
- Incomplete Coaptation2
Patient problems
- Aortic Valve Stenosis33
- Insufficient Information28
- Aortic Valve Insufficiency/ Regurgitation18
- Non specific EKG/ECG Changes9
- No Information8
- Aortic Insufficiency6
- Calcium Deposits/Calcification5
- Pulmonary Valve Insufficiency/ Regurgitation4
HANCOCK II ULTRA models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HANCOCK II ULTRA® T505U225heart-valve, non-allograft tissue12 reports
- HANCOCK II ULTRA® T505U223replacement Heart-valve1 death12 reports
- HANCOCK II ULTRA® T505U225replacement Heart-valve9 reports
- HANCOCK II ULTRA® T505U223heart-valve, non-allograft tissue8 reports
- HANCOCK II ULTRA® T505U221replacement Heart-valve8 reports
- HANCOCK II ULTRA® T505U225replacement Heart-valve7 reports
- HANCOCK II ULTRA® T505U225replacement Heart-valve6 reports
- HANCOCK II ULTRA® T505U227heart-valve, non-allograft tissue4 reports
- HANCOCK II ULTRA® T505U229heart-valve, non-allograft tissue4 reports
- HANCOCK II ULTRA® T505U223replacement Heart-valve4 reports
- HANCOCK II ULTRA® T505U225heart-valve, non-allograft tissue2 reports
- HANCOCK II ULTRA® T505U227replacement Heart-valve2 reports
- HANCOCK II ULTRA® T505U223replacement Heart-valve2 reports
- HANCOCK II ULTRA® T505U221heart-valve, non-allograft tissue1 report
- HANCOCK II ULTRA® T505U227replacement Heart-valve1 report
- HANCOCK II ULTRA® T505U221replacement Heart-valve1 death1 report
- HANCOCK II ULTRA® T505U227replacement Heart-valve1 report
- HANCOCK II ULTRA® T505U221replacement Heart-valve1 report
- HANCOCK II ULTRA® T505U227replacement Heart-valve1 report
Recent HANCOCK II ULTRA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Insufficient Device Problem Information
Medtronic received information that 14 years and 10 months post implant of this 25mm pulmonary bioprosthetic valve, a 18mm transcatheter valve was implanted valve-in-valve. The reason for intervention was not reported. No additional adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50767214 ↗InjuryAug 23, 2026Intravalvular regurgitation
It was reported that 10 years and 6 months post implant of this 25mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was reported as aortic insufficiency. No intervention or adverse patient effects were reported.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 50397596 ↗InjuryApr 20, 2026Insufficient Device Problem Information; Intravalvular regurgitation
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR EVALUATION WAS SEVERE REGURGITATION. SUBSEQUENTLY ON (B)(6) 2026 THE PATIENT SUCCESSFULLY HAD A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information
MAUDE report 24933507 ↗InjuryMar 30, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 10 YEARS AND 4 MONTHS POST IMPLANT 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 24712935 ↗InjuryMar 25, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 24687051 ↗InjuryMar 5, 2026Perivalvular Leak; Insufficient Device Problem Information; Device Stenosis
IT WAS REPORTED THAT 7 YEARS AND 9 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. EVIDENCE OF CALCIFICATION WAS SEEN IN THE RIGHT CORONARY ARTERY (RCA). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification; Valvular Insufficiency/ Regurgitation
MAUDE report 24519745 ↗InjurySep 12, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation
MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 1 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS AND AORTIC REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 6 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis
MAUDE report 23042313 ↗InjurySep 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY AS THE IMPLANT OF THIS HANCOCK II VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 22962096 ↗InjurySep 3, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis
ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR INTERVENTION AS AORTIC STENOSIS (AS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Stenosis; Insufficient Information
MAUDE report 22952090 ↗InjuryAug 18, 2025Intravalvular regurgitation; Intravalvular regurgitation
MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 3 MONTHS POST IMPLANT OF THIS HANCOCK II VALVE IN THE PULMONARY POSITION, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pulmonary Valve Insufficiency/ Regurgitation
MAUDE report 22825652 ↗InjuryAug 11, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis
ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR INTERVENTION AS AORTIC STENOSIS (AS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Stenosis; Insufficient Information
MAUDE report 22772660 ↗InjuryAug 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A 27MM AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AND REPLACED WITH A NEW 27MM AORTIC BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 22725003 ↗InjuryJul 11, 2025Device Stenosis; Device Stenosis
MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 8 MONTHS POST IMPLANT OF THIS HANCOCK II AORTIC VALVE, THE PATIENT WAS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 2 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Stenosis
MAUDE report 22480011 ↗InjuryJul 9, 2025Insufficient Device Problem Information; Material Split, Cut or Torn; Intravalvular regurgitation; Insufficient Device Problem Information; Material Split, Cut or Torn; Intravalvular regurgitation
ADDITIONAL INFORMATION WAS RECEIVED THAT THE 25MM HANCOCK II VALVE WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY. IT WAS STATED THAT THERE WERE "SOME BURNED OUT DEBRIS ON THE AORTIC VALVE WITH ONE TORN LEAFLET". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cusp Tear; Insufficient Information
MAUDE report 22455710 ↗InjuryMay 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 22059508 ↗
Other Medtronic, Inc. products
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- 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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