Medtronic Sprint Quattro LeadRecalls & reported problems across all models
Medtronic, Inc. · 67 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 45,880
- Deaths reported
- 676
- Injuries reported
- 26,582
- Recalls
- 1
We found 67 models of Medtronic Sprint Quattro Lead by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 45,880 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2013 and Sep 30, 2026 — classified as 676 deaths, 26,582 injuries, 18,621 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (17,046 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
Medtronic Sprint Quattro Lead 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.
- Nov 8, 2021Terminated
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
Z-0390-2022 · Root cause: Error in labeling · names 3 of these models · Recall details · FDA record ↗
Most reported Medtronic Sprint Quattro Lead problems
Device problems
- Over-Sensing17,046
- High impedance9,114
- Adverse Event Without Identified Device or Use Problem7,753
- Fracture6,086
- Signal Artifact/Noise6,019
- Impedance Problem5,912
- High Capture Threshold5,035
- Under-Sensing4,442
Patient problems
- No Clinical Signs, Symptoms or Conditions22,371
- No Known Impact Or Consequence To Patient9,382
- Unspecified Infection5,577
- Shock from Patient Lead(s)2,222
- No Consequences Or Impact To Patient1,644
- Sepsis486
- Bacteremia456
- Erythema447
Medtronic Sprint Quattro Lead models
67 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sprint Quattro Secure S MRI™ SureScan™ 6935M62Permanent defibrillator electrodes221 deaths14,405 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M55Permanent defibrillator electrodes116 deaths7,750 reports
- Sprint Quattro Secure® 694765permanent pacemaker Electrode73 deaths3,852 reports
- Sprint Quattro Secure MRI™ SureScan™ 6947M62permanent pacemaker Electrode42 deaths2,612 reports
- Sprint Quattro Secure® 694758permanent pacemaker Electrode25 deaths1,937 reports
- Sprint Quattro Secure S® 6935M62Permanent defibrillator electrodes33 deaths1,731 reports
- Sprint Quattro Secure MRI™ SureScan™ 6947M55permanent pacemaker Electrode19 deaths1,272 reports
- Sprint Quattro Secure® 6947M62Permanent defibrillator electrodes18 deaths1,158 reports
- Sprint Quattro Secure S™ DXAC/DSP 693565Permanent defibrillator electrodes11 deaths1,012 reports
- Sprint Quattro Secure S® 6935M55Permanent defibrillator electrodes13 deaths998 reports
- Sprint Quattro Secure® DXAC/DSP 694765Permanent defibrillator electrodes10 deaths852 reports
- Sprint Quattro Secure® 6947M62Permanent defibrillator electrodes10 deaths796 reports
- Sprint Quattro Secure S® 6935M62Permanent defibrillator electrodes11 deaths735 reports
- Sprint Quattro Secure S MRI™ SureScan™ 693565permanent pacemaker Electrode8 deaths695 reports
- Sprint Quattro Secure S™ 693565Permanent defibrillator electrodes10 deaths657 reports
- Sprint Quattro Secure S™ DXAC/DSP 693558Permanent defibrillator electrodes3 deaths607 reports
- Sprint Quattro Secure® 6947M55permanent pacemaker Electrode8 deaths603 reports
- Sprint Quattro Secure S™ 693558permanent pacemaker Electrode4 deaths515 reports
- Sprint Quattro® 6944-65permanent pacemaker Electrode5 deaths492 reports
- Sprint Quattro Secure S® 6935M55Permanent defibrillator electrodes2 deaths449 reports
- Sprint Quattro Secure® DXAC/DSP 694758permanent pacemaker Electrode3 deaths421 reports
- Sprint Quattro Secure® 6947M55permanent pacemaker Electrode4 deaths391 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M62Permanent defibrillator electrodes3 deaths309 reports
- Sprint Quattro Secure S MRI™ SureScan™ 693558permanent pacemaker Electrode3 deaths278 reports
- Sprint Quattro® 6944-58Permanent defibrillator electrodes6 deaths233 reports
- Sprint Quattro Secure S® 6935M72Permanent defibrillator electrodes1 recall1 death120 reports
- Sprint Quattro Secure MRI™ SureScan™ 694758Implantable cardioverter defibrillator (non-CRT)1 death153 reports
- Sprint Quattro™ MRI SureScan™ 6946M62Implantable cardioverter defibrillator (non-CRT)1 death133 reports
- Sprint Quattro Secure MRI™ SureScan™ 694765Permanent defibrillator electrodes1 death114 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M55permanent pacemaker Electrode2 deaths102 reports
- Sprint Quattro Secure S® 6935M72Permanent defibrillator electrodes1 recall13 reports
- Sprint Quattro Secure S® 6935M72permanent pacemaker Electrode1 recall11 reports
- SPRINT QUATTRO SECURE S™ DXAC/DSP 693565permanent pacemaker Electrode54 reports
- Sprint Quattro® 6946M62Permanent defibrillator electrodes1 death44 reports
- Sprint Quattro™ MRI SureScan™ 6946M55Permanent defibrillator electrodes2 deaths42 reports
- SPRINT QUATTRO SECURE® DXAC/DSP 694765Implantable cardioverter defibrillator (non-CRT)38 reports
- SPRINT QUATTRO SECURE® DXAC/DSP 694758Permanent defibrillator electrodes31 reports
- Sprint Quattro Secure S® 6947M72permanent pacemaker Electrode30 reports
- SPRINT QUATTRO SECURE S™ DXAC/DSP 693558permanent pacemaker Electrode2 deaths27 reports
- Sprint Quattro Secure® 6947M72permanent pacemaker Electrode1 death24 reports
- Sprint Quattro® 6946M55Permanent defibrillator electrodes1 death19 reports
- Sprint Quattro Secure® DXAC/DSP 694775permanent pacemaker Electrode1 death18 reports
- Sprint Quattro Secure® 6947M72permanent pacemaker Electrode17 reports
- SPRINT QUATTRO SECURE S™ DXAC/DSP 693575Implantable cardioverter defibrillator (non-CRT)15 reports
- SPRINT QUATTRO® 6944-65permanent pacemaker Electrode13 reports
- Sprint Quattro Secure S™ 693575permanent pacemaker Electrode11 reports
- Sprint Quattro Secure S MRI™ SureScan™ 693565Implantable cardioverter defibrillator (non-CRT)10 reports
- Sprint Quattro Secure MRI™ SureScan™ 6947M62permanent pacemaker Electrode10 reports
- Sprint Quattro Secure S™ DXAC/DSP 693575Permanent defibrillator electrodes9 reports
- SPRINT QUATTRO SECURE S™ DXAC/DSP 693552Implantable cardioverter defibrillator (non-CRT)9 reports
- Sprint Quattro Secure S™ DXAC/DSP 693552Permanent defibrillator electrodes7 reports
- Sprint Quattro Secure S® 6935M97Permanent defibrillator electrodes7 reports
- Sprint Quattro Secure® 6947100permanent pacemaker Electrode4 reports
- Sprint Quattro Secure S™ 693552permanent pacemaker Electrode4 reports
- Sprint Quattro Secure S® 6935M49Permanent defibrillator electrodes4 reports
- Sprint Quattro Secure S® 6935M49Permanent defibrillator electrodes4 reports
- SPRINT QUATTRO® 6944-58permanent pacemaker Electrode4 reports
- Sprint Quattro Secure S® 6935M49Permanent defibrillator electrodes4 reports
- Sprint Quattro Secure S® 6947M62permanent pacemaker Electrode1 death3 reports
- Sprint Quattro Secure® 6947M97permanent pacemaker Electrode2 reports
- SPRINT QUATTRO SECURE® DXAC/DSP 694775Permanent defibrillator electrodes2 reports
- Sprint Quattro Secure S® 6947M97permanent pacemaker Electrode2 reports
- Sprint Quattro Secure MRI™ SureScan™ 6947M55permanent pacemaker Electrode2 reports
- Sprint Quattro Secure S™ DXAC/DSP 6935100permanent pacemaker Electrode1 report
- Sprint Quattro Secure S™ 6935100permanent pacemaker Electrode1 report
- SPRINT QUATTRO SECURE S™ DXAC/DSP 6935100permanent pacemaker Electrode1 report
- SPRINT QUATTRO SECURE® DXAC/DSP 6947100Permanent defibrillator electrodes1 report
Recent Medtronic Sprint Quattro Lead adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 50955142 ↗MalfunctionSep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954786 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50954550 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Endocarditis; Unspecified Infection
MAUDE report 50953722 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Cardiac Arrest; Cardiac Tamponade; Perforation
MAUDE report 50952740 ↗MalfunctionSep 30, 2026Fracture; High impedance; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952437 ↗InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952425 ↗MalfunctionSep 30, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952133 ↗InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated
Patient problems: Shock from Patient Lead(s); Twiddlers Syndrome
MAUDE report 50951886 ↗MalfunctionSep 30, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951828 ↗InjurySep 30, 2026Fracture; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951647 ↗InjurySep 30, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951539 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacteremia
MAUDE report 50951342 ↗MalfunctionSep 30, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951293 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) resulting in misclassification of arrhythmia episode type. The RV lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951242 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- 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
- Medtronic Azure Pacemaker12 models · 16,566 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered, combining the brand names used for this product line.
- 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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