Attain Ability PlusRecalls & reported problems across all models
Medtronic, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 643
- Deaths reported
- 13
- Injuries reported
- 463
- Recalls
- 0
We found 2 models of Attain Ability Plus by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 643 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2013 and Sep 24, 2026 — classified as 13 deaths, 463 injuries, 167 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (188 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 Attain Ability Plus problems
Device problems
- Adverse Event Without Identified Device or Use Problem226
- High Capture Threshold188
- Failure to Capture84
- High impedance68
- Capturing Problem63
- Device Dislodged or Dislocated47
- Appropriate Device Problem Term/Code Not Available36
- Impedance Problem35
Patient problems
- No Clinical Signs, Symptoms or Conditions183
- No Known Impact Or Consequence To Patient162
- Unspecified Infection141
- Muscle Stimulation34
- Device Overstimulation of Tissue32
- Undesired Nerve Stimulation25
- Endocarditis17
- Erosion15
Attain Ability Plus models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Attain Ability® Plus 429688Drug eluting permanent left ventricular (lv) pacemaker electrode11 deaths529 reports
- Attain Ability® Plus 429678permanent pacemaker Electrode2 deaths114 reports
Recent Attain Ability Plus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathSep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported by the patients representative that the patient implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) system "had a sepsis infection from "[the]" defibrillator ports" and "there was an infection on the lead from "[the]" defibrillator". The patient¿s representative reported the patient was "put on antibiotics instead of replacing as usually done". The patient expired approximately 8 weeks later.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 50883733 ↗MalfunctionSep 15, 2026Capturing Problem
It was reported that the Left Ventricular (LV) lead exhibited an increase in capture thresholds. The LV 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 50777949 ↗InjuryAug 18, 2026High Capture Threshold
It was reported that the Left Ventricular (LV) lead exhibited high thresholds and the Cardiac Resynchronization Therapy Defibrillator (CRT-D) experienced rapid battery depletion. The LV lead was capped and replaced and the CRT-D was explanted and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50306986 ↗MalfunctionAug 14, 2026Failure to Capture; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256776 ↗MalfunctionAug 11, 2026High Capture Threshold
It was reported that the Left Ventricular (LV) lead exhibited high thresholds. The 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 50212264 ↗InjuryJul 31, 2026Extracardiac stimulation
It was reported that the Left Ventricular (LV) lead was causing intermediate diaphragmatic stimulation. The patient elected to have the LV lead programmed off and electrically abandoned. The patient is a participant in a clinical study. No further patient complications have been reported as a result of this event.
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50104298 ↗InjuryJul 29, 2026Capturing Problem
It was reported that progressively increasing Left Ventricular (LV) lead thresholds were observed over the course of two months. LV lead vectors were tested, the lead was reprogrammed and remains in use. The patient is a participant in a clinical study. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50074817 ↗MalfunctionJun 24, 2026Capturing Problem; Impedance Problem
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASING CAPTURE THRESHOLDS WITH A CORRELATING INCREASE IN IMPEDANCE MEASUREMENTS. THE PATIENT EXPERIENCED CHEST PAIN. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Chest Pain
MAUDE report 25616646 ↗MalfunctionJun 12, 2026Failure to Capture; Impedance Problem
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A DROP IN PACING IMPEDANCE AND POTENTIAL LOSS OF CAPTURE. THE LV 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 25491448 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING A STAPHYLOCOCCI INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 25237284 ↗MalfunctionMay 12, 2026High impedance; High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRENDS NOTED CHRONICALLY HIGH THRESHOLDS AND PACING IMPEDANCE. THE LV 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 25156337 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 25144970 ↗MalfunctionMay 11, 2026High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN OVER PACING. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25140079 ↗InjuryMay 6, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS CAPPED AND REPLACED DUE TO AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095485 ↗MalfunctionApr 21, 2026Failure to Capture
IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED LEAD IMPEDANCE WARNING FOR UNDEFINED HIGH RV DEFIBRILLATION IMPEDANCE, UN DEFINED HIGH SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE, AND UNDEFINED HIGH RV TIP TO RV COIL PACING IMPEDANCE. THE LEFT VENTRICULAR (LV) LEAD ALSO EXHIBITED LOSS OF CAPTURE. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24945782 ↗
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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