HANCOCK IIRecalls & reported problems across all models
Medtronic, Inc. · 43 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 333
- Deaths reported
- 14
- Injuries reported
- 306
- Recalls
- 1
We found 43 models of HANCOCK II by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 333 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2016 and Sep 15, 2026 — classified as 14 deaths, 306 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (200 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
HANCOCK II recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 21, 2019Terminated
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Z-1884-2019 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported HANCOCK II problems
Device problems
- Insufficient Device Problem Information200
- Intravalvular regurgitation44
- Adverse Event Without Identified Device or Use Problem43
- Patient Device Interaction Problem39
- Device Stenosis32
- Gradient Increase24
- Calcified11
- Perivalvular Leak11
Patient problems
- Insufficient Information114
- Aortic Valve Stenosis78
- No Information59
- Aortic Valve Insufficiency/ Regurgitation55
- Endocarditis23
- Non specific EKG/ECG Changes22
- Calcium Deposits/Calcification14
- Aortic Regurgitation11
HANCOCK II models
43 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HANCOCK® II T510C31replacement Heart-valve1 recall1 death12 reports
- HANCOCK® II T505C221heart-valve, non-allograft tissue27 reports
- HANCOCK® II T505C223heart-valve, non-allograft tissue27 reports
- HANCOCK® II T505U223heart-valve, non-allograft tissue4 deaths20 reports
- HANCOCK® II T505C225heart-valve, non-allograft tissue18 reports
- HANCOCK® II T505C223replacement Heart-valve1 death15 reports
- HANCOCK® II T505C225replacement Heart-valve2 deaths15 reports
- HANCOCK® II T505C227heart-valve, non-allograft tissue14 reports
- HANCOCK® II T510C27replacement Heart-valve1 death14 reports
- HANCOCK® II T510C31heart-valve, non-allograft tissue1 death13 reports
- HANCOCK® II T505C223replacement Heart-valve12 reports
- HANCOCK® II T510C29replacement Heart-valve1 death11 reports
- HANCOCK® II T510C33replacement Heart-valve11 reports
- HANCOCK® II T510C27heart-valve, non-allograft tissue10 reports
- HANCOCK® II T505C225replacement Heart-valve10 reports
- HANCOCK® II T510C29heart-valve, non-allograft tissue7 reports
- HANCOCK® II T505C225replacement Heart-valve7 reports
- HANCOCK® II T505C227replacement Heart-valve7 reports
- HANCOCK® II T505C221replacement Heart-valve6 reports
- HANCOCK® II T510C33heart-valve, non-allograft tissue6 reports
- HANCOCK® II T505C225heart-valve, non-allograft tissue5 reports
- HANCOCK® II T505C229heart-valve, non-allograft tissue5 reports
- HANCOCK® II T505U221heart-valve, non-allograft tissue5 reports
- HANCOCK® II T510C25heart-valve, non-allograft tissue4 reports
- HANCOCK® II T510C25heart-valve, non-allograft tissue1 death4 reports
- HANCOCK® II T510C29replacement Heart-valve4 reports
- HANCOCK® II T505C223replacement Heart-valve4 reports
- HANCOCK® II T505C227replacement Heart-valve4 reports
- HANCOCK® II T510C25replacement Heart-valve4 reports
- HANCOCK® II T510C29replacement Heart-valve3 reports
- HANCOCK® II T505C223heart-valve, non-allograft tissue3 reports
- HANCOCK® II T505C227heart-valve, non-allograft tissue3 reports
- HANCOCK® II T505C227replacement Heart-valve3 reports
- HANCOCK® II T505C221replacement Heart-valve3 reports
- HANCOCK® II T505C229replacement Heart-valve3 reports
- HANCOCK® II T510C25replacement Heart-valve1 death3 reports
- HANCOCK® II T510C27replacement Heart-valve2 reports
- HANCOCK® II T505C221replacement Heart-valve2 reports
- HANCOCK® II T505C229replacement Heart-valve2 reports
- HANCOCK® II T510C27replacement Heart-valve1 death2 reports
- HANCOCK® II T510C31heart-valve, non-allograft tissue1 report
- HANCOCK® II T505C229heart-valve, non-allograft tissue1 report
- HANCOCK® II T510C27replacement Heart-valve1 report
Recent HANCOCK II 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 7 years and 7 months post implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with a 25mm aortic bioprosthetic valve of a different model. The reason for the replacement was not reported. No additional adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50767165 ↗InjurySep 9, 2026Device Stenosis
Additional Information received reported that on (b)(6) 2026, the patient successfully had a 23mm aortic transcatheter valve-in-valve replacement. No additional adverse patient effects were reported.
Patient problems: Aortic Valve Stenosis
MAUDE report 50687756 ↗InjuryAug 23, 2026Intravalvular regurgitation
It was reported that 8 years and 10 months post implant of this 23mm 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 50397593 ↗MalfunctionAug 17, 2026Insufficient Device Problem Information
It was reported that 12 years and 6 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. No intervention or adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50272573 ↗InjuryJul 30, 2026Device Stenosis; Intravalvular regurgitation
It was reported that 13 years and 9 months post implant of this 23mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was reported as severe aortic stenosis. It was reported that an intervention was required and scheduled for (b)(6) 2026. No additional adverse patient effects were reported.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis
MAUDE report 50088928 ↗InjuryJul 29, 2026Device Stenosis
It was reported that 10 years and 9 months post implant of this 27mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was reported as stenosis. It was reported that an intervention is required. Subsequently 3 days later on (b)(6) 2026 the patient successfully had a 26mm aortic transcatheter valve-in-valve replacement. No additional adverse patient effects were reported.
Patient problems: Aortic Valve Stenosis
MAUDE report 50068756 ↗MalfunctionJun 15, 2026Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 2 MONTHS POST IMPLANT OF THIS 27 MM HANCOCK II AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25500059 ↗InjuryJun 12, 2026Patient Device Interaction Problem
MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION ARREST. IT WAS FURTHER NOTED THAT ONE DAY LATER, STERNAL REENTRY WAS PREFORMED DUE TO MEDIASTINAL BLEEDING AND THE PATIENT WAS STARTED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). IT WAS ALSO REPORTED THAT THE BLEEDING WAS REPAIRED AND THE PATIENT HAD CEREBROVASCULAR ACCIDENT (CVA). HOSPITALIZATION WAS PROLONGED. THE PATIENT WAS DISCHARGED ONE DAY LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information; Stroke/CVA; Ventricular Fibrillation
MAUDE report 25487574 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 8 MONTHS POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL BIOPROSTHETIC VALVE OF A NEW MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25301412 ↗DeathMay 1, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT 10 YEARS AND 9 MONTHS POST IMPLANT OF THIS 23 MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT WAS REPORTED DECEASED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE VALVE COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.
Patient problems: Insufficient Information
MAUDE report 25056422 ↗InjuryApr 29, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 9 MONTHS POST IMPLANT OF THIS 25MM MITRAL 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 25026637 ↗InjuryApr 29, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT POST IMPLANT OF THIS 31MM HANCOCK VALVE IMPLANTED IN THE TRICUSPID POSITION ON THE SAME DAY, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB) AND VALVE DISEASE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Heart Block
MAUDE report 25026531 ↗InjuryApr 27, 2026Calcified; Perivalvular Leak; Patient Device Interaction Problem; Intravalvular regurgitation
ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR EVALUATION PER ECHOCARDIOGRAM (ECHO) ON (B)(6) 2025 WAS LOW EJECTION FRACTION 30% AND MODERATE REGURGITATION. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification; Thrombosis/Thrombus
MAUDE report 24998934 ↗InjuryApr 9, 2026Device Stenosis
IT WAS REPORTED THAT 3 YEARS AND 7 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS. SUBSEQUENTLY ON (B)(6), 2026 THE PATIENT SUCCESSFULLY HAD A 26MM AORTIC TRANSCATHETER VALVE-IN- VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Stenosis
MAUDE report 24827936 ↗InjuryMar 30, 2026Device Stenosis
IT WAS REPORTED THAT 11 YEARS AND 2 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS VALVE STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Stenosis
MAUDE report 24728190 ↗
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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