ZOOM LATITUDERecalls & reported problems across all models

We found 9 models of ZOOM LATITUDE by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 80 adverse event reports in the FDA's MAUDE database, received between Oct 2, 2017 and Nov 27, 2023 — classified as 1 death, 4 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Defective Device” (33 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 still open.

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

ZOOM LATITUDE 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.

1. Nov 30, 2023Open, Classified

   The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.

   Z-0673-2024 · Root cause: Under Investigation by firm · names 9 of these models · Recall details · FDA record ↗

2. Jul 7, 2022Open, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1671-2022 · Root cause: Under Investigation by firm · names 9 of these models · Recall details · FDA record ↗

3. Jul 7, 2022Open, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1670-2022 · Root cause: Under Investigation by firm · names 9 of these models · Recall details · FDA record ↗

4. Jul 7, 2022Open, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1669-2022 · Root cause: Under Investigation by firm · names 9 of these models · Recall details · FDA record ↗

Most reported ZOOM LATITUDE problems

ZOOM LATITUDE models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ZOOM® LATITUDE® 3120

  Implantable cardioverter defibrillator (non-CRT)
  4 recalls1 death65 reports
• ZOOM® LATITUDE® 3120

  Implantable cardioverter defibrillator (non-CRT)
  4 recalls9 reports
• ZOOM® LATITUDE® 3120

  Implantable cardioverter defibrillator (non-CRT)
  4 recalls4 reports
• ZOOM® LATITUDE® 3120

  Implantable cardioverter defibrillator (non-CRT)
  4 recalls1 report
• ZOOM® LATITUDE® 3120

  Implantable cardioverter defibrillator (non-CRT)
  4 recalls1 report
• ZOOM® LATITUDE® 3120

  Implantable cardioverter defibrillator (non-CRT)
  4 recalls0 reports
• ZOOM® LATITUDE® 3120

  Implantable cardioverter defibrillator (non-CRT)
  4 recalls0 reports
• ZOOM® LATITUDE® 3120

  Implantable cardioverter defibrillator (non-CRT)
  4 recalls0 reports
• ZOOM® LATITUDE® 3120

  Implantable cardioverter defibrillator (non-CRT)
  4 recalls0 reports

Recent ZOOM LATITUDE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS PROGRAMMER HAD A BURNING SMELL WHEN TURNED ON. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PROGRAMMER ISSUE WAS NOT RESOLVED. THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT WAS REPORTED. THIS PROGRAMMER WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212993 ↗
• MalfunctionDec 12, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT A SMALL PUFF OF SMOKE CAME OUT FROM THE PROGRAMMER WHEN POWERED ON AND BURNING SMELL WAS OBSERVED. NO ADVERSE EFFECT WAS REPORTED. THE PROGRAMMER WAS BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15963970 ↗
• DeathNov 30, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PROGRAMMER STARTED SMOKING UPON PLUGGING IN. AS OF THIS TIME, THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15889047 ↗
• MalfunctionJul 28, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THIS PROGRAMMER EMITTED FUME WHEN THE POWER CABLE WAS CONNECTED. NO ADVERSE PATIENTS EFFECTS WERE REPORTED. THE PROGRAMMER WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122653 ↗
• InjuryJun 3, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHILE PERFORMING A THREHSOLD TEST THE SCREEN OF THIS PROGRAMMER FROZE PREVENTING THE HALTING OF THIS TEST. THE PATIENT WAS DEPENDENT AND DUE TO LOSS OF CAPTURE (LOC), THE PATIENT LOST CONSCIOUSNESS. THE PROGRAMMER WAS REMOVED FROM SERVICE. TECHNICAL SERVICES (TS) EDUCATED THE CALLER THAT HAD THE PROGRAMMER WAND BEEN REMOVED FROM THE PATIENT THIS TOO WOULD HAVE ENDED THE THRESHOLD TEST.

  Patient problems: Syncope/Fainting

  MAUDE report 14595160 ↗
• MalfunctionApr 20, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN THE PROGRAMMER WAS STARTED, THE SCREEN DID NOT LIGHT UP AND THERE WAS A SMOKE FROM THE EDGE OF THE SCREEN. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO ADVERSE PATIENT EFFECT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164167 ↗
• MalfunctionMar 2, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER MADE A CLICK TONE, THE SCREEN TURNED BLACK AND PRESENTED A BURNT SMELL. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656435 ↗
• MalfunctionFeb 6, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER COULD NOT BE TURNED ON AND IT WAS ACCOMPANIED BY SPECIAL SMELL. THE PHYSICIAN SUSPECTED ELECTRONIC COMPONENTS BURNED OUT. NO ADVERSE PATIENT EFFECT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467427 ↗
• InjuryJan 22, 2022Date/Time-Related Software Problem; Date/Time-Related Software Problem

  IT WAS REPORTED THAT THIS PATIENT PASSED OUT AND WAS ADMITTED TO THE HOSPITAL. UPON REVIEW OF DEVICE DATA, IT WAS OBSERVED THAT THIS PROGRAMMER RESET THE PATIENT'S DEVICE AND CAUSED EPISODE DATES TO BE SAVED UNDER A YEAR OTHER THAN CURRENT. IT WAS NOTED THE PROGRAMMER WAS LOCATED AT THE PHYSICIAN'S OFFICE, SO NOT SURE HOW LONG THE DEVICE HAD BEEN RESET TO THAT DATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PROGRAMMER IS NO LONGER IN USE.

  Patient problems: Syncope/Fainting

  MAUDE report 13326864 ↗
• MalfunctionNov 7, 2021Unexpected Therapeutic Results; Material Integrity Problem; Unexpected Therapeutic Results; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DEVICE FOLLOW-UP, THE PHYSICIAN PERFORMED A THRESHOLD TEST. HOWEVER, THE PACEMAKER-DEPENDENT PATIENT WENT INTO ASYSTOLE, WITH DIZZINESS AND MALAISE. THE PROGRAMMER TOUCHSCREEN WOULD NOT RESPOND SO THE PHYSICIAN COULD NOT STOP THE TEST IMMEDIATELY. THE PATIENT RECOVERED WITH NO INTERVENTION OR ADDITIONAL ADVERSE EFFECTS. THE PROGRAMMER WILL BE RETURNED FOR ANALYSIS AND REPAIR.

  Patient problems: Asystole; Dizziness; Malaise

  MAUDE report 12756325 ↗
• MalfunctionOct 28, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PROGRAMMER HAD SMOKE EMERGED ON THE SIDE UPON START UP BUT THERE NO FIRE AND IT DOESN'T FEEL HOT TO TOUCH. REP UNPLUGGED THE PROGRAMMER AND WILL RETURN THE PRODUCT. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716706 ↗
• MalfunctionSep 22, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER PRESENTED A RUBBER BURNING SMELL AND TURNED OFF BY IT SELF. ALSO, SOME SMOKE WAS OBSERVED. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516503 ↗
• MalfunctionSep 16, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT 3120 PROGRAMMER BLEW UP WHEN ATTEMPTING TO TURN ON. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481613 ↗
• MalfunctionJul 28, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT WHEN TURNING ON THE PROGRAMMER SCREEN SUDDENLY WENT BLACK AND THERE WAS A SMELL OF BURNING. FURTHERMORE THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO ADVERSE PATIENTS EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243050 ↗
• MalfunctionJun 25, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER SOCKET WAS BURNED OUT AND DID NOT TURN ON. FURTHERMORE, THE PROGRAMMER WILL BE REPLACED AND RETURNED FOR REPAIR/ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071946 ↗

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