Attain Stability Quad MRI SureScanRecalls & 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
- 2,627
- Deaths reported
- 32
- Injuries reported
- 1,611
- Recalls
- 0
We found 2 models of Attain Stability Quad MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 2,627 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2019 and Sep 30, 2026 — classified as 32 deaths, 1,611 injuries, 984 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (535 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 Stability Quad MRI SureScan problems
Device problems
- Adverse Event Without Identified Device or Use Problem981
- High Capture Threshold535
- Device Dislodged or Dislocated377
- Failure to Capture328
- Capturing Problem206
- High impedance163
- Activation, Positioning or Separation Problem132
- Low impedance109
Patient problems
- No Clinical Signs, Symptoms or Conditions1,244
- Unspecified Infection467
- Device Overstimulation of Tissue223
- Undesired Nerve Stimulation166
- No Consequences Or Impact To Patient95
- No Known Impact Or Consequence To Patient93
- Erythema81
- Discomfort71
Attain Stability Quad MRI SureScan models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Attain Stability™ Quad MRI SureScan™ 479888Drug eluting permanent left ventricular (lv) pacemaker electrode28 deaths2,213 reports
- Attain Stability™ Quad MRI SureScan™ 479878Drug eluting permanent left ventricular (lv) pacemaker electrode4 deaths414 reports
Recent Attain Stability Quad MRI SureScan adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Extracardiac stimulation
It was reported that the patient complained of diaphragmatic stimulation after eating causing discomfort. The Left Ventricular (LV) lead was reprogrammed to mitigate the symptoms. It was also noted that the Right Atrial (RA) lead exhibited variable impedance and somewhat elevated in the pacing impedance trends. Additionally, the Right Ventricular (RV) lead exhibited increasing thresholds initially, but had stabilized. All three leads remain in use. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue
MAUDE report 50950550 ↗MalfunctionSep 30, 2026Contamination; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949292 ↗InjurySep 30, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949036 ↗MalfunctionSep 29, 2026Capturing Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937944 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50935756 ↗MalfunctionSep 29, 2026Failure to Capture
It was reported that the Left Ventricular (LV) lead exhibited possible 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 50935188 ↗InjurySep 25, 2026Extracardiac stimulation
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50905900 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacterial Infection; Fungal Infection; Medical device site infection
MAUDE report 50903962 ↗MalfunctionSep 25, 2026High Capture Threshold
It was reported that the Left Ventricular (LV) lead exhibited high 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 50900365 ↗MalfunctionSep 25, 2026Impedance Problem
It was reported that the Right Ventricular (RV) lead exhibited an acute drop in pacing impedance and an acute rise to high thresholds. The Left Ventricular (LV) lead also exhibited an acute drop in pacing impedance. 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 50896592 ↗InjurySep 24, 2026High Capture Threshold
It was reported that high Left Ventricular (LV) lead thresholds were observed which depleted the Cardiac Resynchronization Therapy D efibrillator (CRT-D) battery. The CRT-D was explanted and replaced; the LV lead was capped and replaced. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889012 ↗MalfunctionSep 24, 2026Intermittent Capture
It was reported that the Left Ventricular (LV) lead exhibited intermittent loss of capture. The LV lead remains in use. No patient c omplications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885633 ↗InjurySep 24, 2026Device Dislodged or Dislocated; High Capture Threshold
It was reported that the Left Ventricular (LV) lead had a history of high thresholds and had a suspected microdislodgement. The LV lead vector was previously reprogrammed. 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 50884879 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection and septic shock. A leadless Implantable Pulse Generator (IPG) was implanted. No further patient complications have been reported as a result of this event.
Patient problems: Septic Shock; Unspecified Infection
MAUDE report 50870669 ↗InjurySep 23, 2026Extracardiac stimulation
It was reported that the patient was feeling unwell and experienced possible extracardiac stimulation from the Left Ventricular (LV) lead pacing. It was further reported that the LV lead was programmed off because the patient was experiencing discomfort and anxiety. No further patient complications have been reported as a result of this event.
Patient problems: Anxiety; Discomfort
MAUDE report 50869709 ↗
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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