HANCOCKRecalls & reported problems across all models
Medtronic, Inc. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 130
- Deaths reported
- 0
- Injuries reported
- 128
- Recalls
- 0
We found 22 models of HANCOCK by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 130 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2017 and Apr 3, 2026 — classified as 128 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (101 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 problems
Device problems
- Insufficient Device Problem Information101
- Gradient Increase18
- Device Stenosis7
- Adverse Event Without Identified Device or Use Problem6
- Patient Device Interaction Problem6
- Intravalvular regurgitation4
- Calcified2
- Inadequacy of Device Shape and/or Size2
Patient problems
- Pulmonary Valve Stenosis49
- No Information46
- Insufficient Information38
- Pulmonary Valve Insufficiency/ Regurgitation16
- Pulmonary Insufficiency10
- Pulmonary Regurgitation7
- Non specific EKG/ECG Changes6
- Calcium Deposits/Calcification4
HANCOCK models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HANCOCK® HC15025heart-valve, non-allograft tissue25 reports
- HANCOCK® HC15022heart-valve, non-allograft tissue23 reports
- HANCOCK® HC15018heart-valve, non-allograft tissue13 reports
- HANCOCK® HC105-22replacement Heart-valve10 reports
- HANCOCK® HC15016heart-valve, non-allograft tissue10 reports
- HANCOCK® HC105-20replacement Heart-valve9 reports
- HANCOCK® HC15020heart-valve, non-allograft tissue9 reports
- Hancock™ HC15025heart-valve, non-allograft tissue5 reports
- HANCOCK® HC105-26replacement Heart-valve5 reports
- HANCOCK® HC150-12replacement Heart-valve5 reports
- Hancock™ HC105-20replacement Heart-valve2 reports
- Hancock™ HC15022heart-valve, non-allograft tissue2 reports
- HANCOCK® HC105-12replacement Heart-valve2 reports
- HANCOCK® HC150-14replacement Heart-valve2 reports
- Hancock™ HC105-12replacement Heart-valve1 report
- Hancock™ HC105-16replacement Heart-valve1 report
- Hancock™ HC105-26replacement Heart-valve1 report
- Hancock™ HC15016heart-valve, non-allograft tissue1 report
- Hancock™ HC15018heart-valve, non-allograft tissue1 report
- Hancock™ HC15020heart-valve, non-allograft tissue1 report
- HANCOCK® HC105-14replacement Heart-valve1 report
- Hancock™ HC150-20heart-valve, non-allograft tissue1 report
Recent HANCOCK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT 7 YEARS AND 6 MONTHS POST IMPLANT OF THIS 22MM HANCOCK VALVE CONDUIT, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS SICK SINUS SYNDROME (SSS) AND PRIMARY PREVENTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 24775844 ↗InjuryNov 19, 2025Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation
IT WAS REPORTED THAT 14 YEARS AND 4 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVE CONDUIT, IN A THEN 14 YEAR OLD PEDIATRIC PATIENT, A 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS STENOSIS, SEVERE PULMONARY INSUFFICIENCY AND HIGH GRADIENT (31MMHG). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis
MAUDE report 23592790 ↗InjurySep 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 2 MONTHS POST IMPLANT OF THIS HANCOCK VALVED CONDUIT, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 23049292 ↗InjuryJan 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT 22 YEARS AND 5 MONTHS POST IMPLANT OF THIS 22MM VALVED CONDUIT, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 21124682 ↗InjuryJan 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 11 MONTHS POST IMPLANT POST IMPLANT OF THIS 22MM VALVED CONDUIT, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Heart Block
MAUDE report 21124515 ↗InjuryNov 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS AND 9 MONTHS POST IMPLANT OF THIS 26MM PULMONARY VALVED CONDUIT, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIOVENTRICULAR BLOCK OR COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Heart Block
MAUDE report 20746467 ↗InjuryNov 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 9 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 16 YEARS, 11 MONTHS OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 25MM PULMONARY VALVED CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 20663204 ↗MalfunctionNov 1, 2024Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS 20MM PULMONARY VALVED CONDUIT, IT WAS REPORTED THAT THE GLASS STORAGE TUBE CONTAINING THE CONDUIT WAS OBSERVED TO HAVE CRACKED AND ALL FLUIDS DRAINED UPON OPENING THE BOX. IT WAS NOTED THAT A PORTION OF THE GLASS STORAGE TUBE HAD BROKEN OFF. IT WAS STATED THAT THE SURROUNDING AREA WHERE THE BOX WAS KEPT SHOWED NO SIGNS OF WETNESS. IT WAS ALSO STATED THAT THERE WERE NO SIGNS OF PACKAGING WETNESS OR DAMAGE AND DAMAGE WAS ONLY DISCOVERED UPON OPENING THE PACKAGE. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20585600 ↗InjuryOct 30, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation
MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 1 MONTH POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 13 YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS PULMONARY STENOSIS AND MODERATE PULMONARY REGURGITATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD A COVERED STENT IMPLANTED PRIOR TO VALVE IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis
MAUDE report 20570879 ↗InjuryOct 21, 2024Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation
MEDTRONIC RECEIVED INFORMATION THAT AFTER AN UNKNOWN DURATION POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE PULMONARY REGURGITATION (AR), PULMONARY STENOSIS (AS) AND A GRADIENT OF 25MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis
MAUDE report 20491762 ↗InjurySep 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A THEN 2 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 20300696 ↗InjuryJul 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 15 YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 19803754 ↗InjuryJun 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 9 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 14 YEAR OLD PEDIATRIC PATIENT, A 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 19615747 ↗InjuryJun 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 9 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A CONDUIT OF THE SAME MODEL AND SIZE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 19578907 ↗InjuryJun 10, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis
MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 12 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A CONDUIT OF THE SAME MODEL. AND SIZE THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information; Pulmonary Valve Stenosis
MAUDE report 19505513 ↗
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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