Percepta™ CRT-P MRI SureScan™ W1TR01 (UDI 00643169735637)Recalls & reported problems

Summary

The FDA's MAUDE database contains 218 adverse event reports that list this exact device (DI 00643169735637), received between Dec 7, 2017 and Apr 8, 2026 — classified as 2 deaths, 136 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (48 reports).

1 FDA recall record name this device's identifier.

9 other recalls cover devices cleared under the same FDA submission (P010015); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 21, 2018Class IITerminated

   Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).

   Z-2412-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 218 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND BRADYCARDIA AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PACING BELOW THE LOWER RATE. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 24816717 ↗
• InjuryApr 3, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED DUE TO UNSPECIFIED ALLEGATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777020 ↗
• MalfunctionNov 19, 2025Pacing Problem; Battery Problem; Communication or Transmission Problem; Pacing Problem; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), THERE WAS AN ATTEMPT TO INTERROGATE THE DEVICE BUT THE MONITOR WAS UNABLE TO LOCATE THE DEVICE. IT WAS NOTED THAT THE CRT-P HAD REACHED END OF SERVICE (EOS) APPROXIMATELY 26 MONTHS AGO. IT WAS ALSO REPORTED THAT THE PATIENT'S HEART RATE WAS IN THE 40'S WHICH IS BELOW THE CRT-P PROGRAMMED LOWER RATE SETTING. THE CRT-P REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 23596426 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET EROSION AND POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions; Pocket Erosion

  MAUDE report 23435352 ↗
• InjuryAug 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THERE WAS A COMPLICATION WITH THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) THAT LED TO THE DOCTOR IMPLANTING A NEW LEAD. THE CRT-P WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22684497 ↗
• InjuryJun 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED NON-PROPHYLACTICALLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323124 ↗
• InjuryJun 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE STROKES AND VERY BAD PAIN. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED WITH AN IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT REPORTED THEY FELT VERY BAD PAIN. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Stroke/CVA

  MAUDE report 22313587 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS REMOVED DUE TO INFECTION, SPECIFICALLY FROM THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS PACED FOR A FEW DAYS AND THEN RECEIVED A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21166746 ↗
• MalfunctionDec 3, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS NOTED THAT THE LONGEVITY ESTIMATE DECREASED A YEAR AND A HALF BETWEEN OFFICE VISITS. THE CRT-P 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 20835618 ↗
• MalfunctionDec 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT THOUGHT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS NOT WORKING PROPERLY. THE DEVICE 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 20819737 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE LEFT SIDED CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED, DUE TO AN INFECTION. A NEW IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED ON THE RIGHT SIDE 6 DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20675905 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SYSTEMIC INFECTION OF THE POCKET. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20370425 ↗
• InjurySep 23, 2024Premature Discharge of Battery; Premature Discharge of Battery

  ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CRT-P WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276332 ↗
• InjuryJul 25, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE HIS LEAD THAT IS IN THE RIGHT VENTRICULAR (RV) PORT OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED A PROGRESSIVE RISE IN THRESHOLDS. THE PROGRESSIVE RISE IN THRESHOLDS RESULTED IN PREMATURE BATTERY DEPLETION OF THE CRT-P. THE LEAD AND CRT-P WERE 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 19833868 ↗
• InjuryJul 10, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE TWO EPICARDIAL LEFT VENTRICULAR (LV) LEAD LEADS EXHIBITED CHRONICALLY HIGH THRESHOLDS. THE HIGH THRESHOLDS RESULTED IN PREMATURE BATTERY DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THE LV LEADS WERE CAPPED AND REPLACED. THE CRT-P 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 19715723 ↗
• InjuryApr 24, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS AN INITIAL HIGH CURRENT DRAIN ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH HIGH RIGHT VENTRICULAR (RV) LEAD PACING AMPLITUDE OUTPUT. THE RV LEAD WAS REPROGRAMMED WHICH ALLOWED THE BATTERY VOLTAGE TO RECOVER TO AN EXTENT. THE RV LEAD WAS LATER REPROGRAMMED A SECOND TIME, WHICH CAUSED THE BATTERY VOLTAGE TO DROP AGAIN BUT REMAIN STABLE. A CLINICIAN, HOWEVER, QUESTIONED A RECENT SUDDEN DECREASE IN LONGEVITY. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE CRT-D WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173280 ↗
• InjuryFeb 19, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RA LEAD EXHIBITED UNDERSENSING. THE RA LEAD WAS EXPLANTED AND REPLACED. IT WAS REPORTED THAT THE RV LEAD EXHIBITED OVERSENSING. THE RV LEAD WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LEADS HAD HIGH PACING THRESHOLDS CAUSING BATTERY DRAIN OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THE PATIENT ALSO EXPERIENCED PACING INDUCED CARDIOMYOPATHY. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEFT VENTRICULAR (LV) LEAD WAS ALSO EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiomyopathy

  MAUDE report 18731505 ↗
• MalfunctionDec 8, 2023Pacing Problem; Pacing Problem

  IT WAS LATER REPORTED THAT THERE WERE NO SENSING OR CAPTURE ISSUES; SENSING AND CAPTURE WERE APPROPRIATE.

  Patient problems: Arrhythmia

  MAUDE report 18292064 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE CRT-P WAS REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). IT WAS NOTED THAT THE PATIENT EXPERIENCED DISCOMFORT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 18266894 ↗
• InjuryNov 3, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH THRESHOLDS ON THE COMPETITOR LEADS. THE CRTP 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 18066623 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STATED GOT "STAPH INFECTION AND IT GOT INTO THE BLOOD STREAM".  THE PATIENT INDICATED ALREADY WORKING WITH THE PHYSICIAN.  THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 18056036 ↗
• InjuryAug 7, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS THAT CONTRIBUTED TO THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EARLY BATTERY DEPLETION WITH ELECTIVE REPLACEMENT INDICATOR (ERI) THAT TRIGGERED.  THE RA LEAD WAS CAPPED, REMAINS IN THE PATIENT, AND A NEW RA LEAD WAS IMPLANTED.  THE RV LEAD REMAINS IN USE, NO ACTION TAKEN.  THE CRT-P 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 17471241 ↗
• InjuryAug 4, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) EPICARDIAL LEAD EXHIBITED A HIGH THRESHOLD AND THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED POSSIBLE PREMATURE BATTERY DEPLETION. THE LV LEAD WAS CAPPED AND REPLACED WITH A LEFT BUNDLE BRANCH LEAD. THE CRT-P WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461028 ↗
• InjuryJul 19, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE TRANSVENOUS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS, CONTRIBUTING TO PREMATURE DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) BATTERY. THE LEAD WAS CAPPED AND REPLACED WITH AN EPICARDIAL LEAD WHICH YIELDED A MUCH LOWER THRESHOLD. THE CRT-P 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 17349231 ↗
• MalfunctionJul 5, 2023False Alarm; False Alarm

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED A FALSE LOW IMPEDANCE WARNING FOR THE LEFT VENTRICULAR (LV) LEAD. THE CRT-P 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 17259862 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010015. One submission often covers many models, so check the product and lot details in each record.

• Z-2127-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
• Z-2128-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
• Z-2512-2020 · Jun 4, 2020 · Open, Classified
  Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
• Z-2513-2020 · Jun 4, 2020 · Open, Classified
  Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
• Z-2511-2020 · Jun 4, 2020 · Open, Classified
  Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
• Z-2415-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-2414-2018 · Jun 21, 2018 · Terminated
  Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and
• Z-2413-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.