LATITUDE Programming SystemRecalls & reported problems across all models

We found 12 models of LATITUDE Programming System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 320 adverse event reports in the FDA's MAUDE database, received between Oct 18, 2018 and Sep 15, 2026 — classified as 4 injuries, 316 malfunctions.

The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (245 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

Most reported LATITUDE Programming System problems

LATITUDE Programming System models

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

• LATITUDE™ Programming System 3300

  Pacemaker/icd/crt non-implanted components
  141 reports
• LATITUDE™ Programming System 3300

  Pacemaker/icd/crt non-implanted components
  72 reports
• LATITUDE™ Programming System 3300

  Pacemaker/icd/crt non-implanted components
  57 reports
• LATITUDE™ Programming System 3300

  Pacemaker/icd/crt non-implanted components
  22 reports
• LATITUDE™ Programming System 3300

  Pacemaker/icd/crt non-implanted components
  16 reports
• LATITUDE™ Programming System 3300

  Pacemaker/icd/crt non-implanted components
  2 reports
• LATITUDE™ Programming System 3300

  Pacemaker/icd/crt non-implanted components
  2 reports
• LATITUDE™ Programming System 623300-111

  Pacemaker/icd/crt non-implanted components
  2 reports
• LATITUDE™ Programming System 623300-112

  Pacemaker/icd/crt non-implanted components
  2 reports
• LATITUDE™ Programming System 3300

  Pacemaker/icd/crt non-implanted components
  2 reports
• LATITUDE™ Programming System 3300

  Pacemaker/icd/crt non-implanted components
  1 report
• LATITUDE™ Programming System 3300

  Pacemaker/icd/crt non-implanted components
  1 report

Recent LATITUDE Programming System adverse event reports

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

• MalfunctionSep 15, 2026No Display/Image; Key or Button Unresponsive/not Working

  It was reported that the integrated programmer touchscreen was not responding in turning the power on and off which progressively displayed a black screen. Technical Services (TS) advised that the programmer needs to be returned. As of this time, this programmer. No patient involvement.Additional information received indicates that this programmer was out of service and was returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774309 ↗
• MalfunctionSep 15, 2026Nonstandard Device; Date/Time-Related Software Problem

  It was reported that this integrated programmer synchronized device with incorrect date/time. Boston Scientific Technical Services (TS) advised that this programmer should be returned, and the device should be reinterrogated with accurate programmer to correct date/time. This programmer will be returned. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771725 ↗
• MalfunctionSep 10, 2026Nonstandard Device; Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721280 ↗
• MalfunctionAug 24, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50407997 ↗
• MalfunctionAug 20, 2026Application Program Problem; Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358886 ↗
• MalfunctionAug 17, 2026Nonstandard Device; Key or Button Unresponsive/not Working

  It was reported that the touchscreen of this integrated programmer was unresponsive. Boston Scientific Technical Services (TS) recommended to return the device. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50271002 ↗
• MalfunctionAug 17, 2026Nonstandard Device; Date/Time-Related Software Problem

  It was reported that this integrated programmer displayed a low CMOS battery message. Boston Scientific Technical Services (TS) explained this can happen after a programmer is updated with the enhanced connectivity software. This will recalibrate the programmer which can reset the CMOS battery. TS advised if the same message shows, will need to return device for replacement. This device remains in service. No patient involvement.Additional information indicates that this programmer is having repetitive CMOs battery issues and will be sent for return.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50270993 ↗
• MalfunctionAug 11, 2026Nonstandard Device; Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216511 ↗
• MalfunctionJul 1, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE INTEGRATED PROGRAMMER SCREEN FROZE WHILE SAVING TO UNIVERSAL SERIAL BUS (USB). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED TO POWER DOWN AND RE-INTERROGATE. SUBSEQUENTLY, THE DATA WAS SUCCESSFULLY SAVED TO A DRIVE, NOT THE USB. AS OF THIS TIME, THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25674408 ↗
• MalfunctionJun 4, 2026Wireless Communication Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR HELP WITH INTERROGATING THIS PATIENT WITH THIS PROGRAMMER. DURING THE INTERROGATION, THE SCREEN FROZE AND TS NOTED THEY HAD TO ERASE ALL THE DATA. EVENTUALLY, TS HELPED THE HCP SUCCESSFULLY INTERROGATE THE PATIENT, HOWEVER, THE DATA WAS UNABLE TO BE SENT DUE TO A BROKEN CELL ADAPTER. IT WAS ALSO NOTED THE PROGRAMMER WAS UNABLE TO CONNECT TO THE WIFI. AFTER RE-BOOTING THE PROGRAMMER, THE DATA WAS STILL UNABLE TO BE SENT. THE HCP TRIED CONNECTING THE PROGRAMMER TO TWO DIFFERENT WIFI ACCOUNTS BUT WAS STILL UNSUCCESSFUL BECAUSE THE SCREEN KEPT FREEZING. TS TRANSFERRED THE HCP FOR ADDITIONAL ASSISTANCE AND CONTACTED A LOCAL TEAM TO REPLACE THE CELL ADAPTER. THIS PROGRAMMER REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402927 ↗
• MalfunctionJun 3, 2026No Display/Image; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE SCREEN OF THIS INTEGRATED PROGRAMMER LOCKS AND IS NON-RESPONSIVE TO TOUCH. THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375967 ↗
• MalfunctionMay 29, 2026Nonstandard Device; Date/Time-Related Software Problem

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER GETS A BLACK SCREEN WHEN BOOTS UP. ADDITIONAL INFORMATION ALSO INDICATES THAT THE INTERNAL CLOCK EXHIBITED AN ERROR. BOSTON SCIENTIFIC TECHNICAL SERVICE (TS) ASSISTED IN TROUBLESHOOTING AND RECOMMEND CONNECTING TO WI-FI AND REBOOTING. IF IT PERSISTS, CONTACT TECHNICAL SERVICES FOR FURTHER ASSISTANCE. THE PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340682 ↗
• MalfunctionMay 14, 2026Material Integrity Problem

  IT WAS REPORTED THAT PHYSICAL DAMAGE AND FLUID INGRESS WERE OBSERVED IN THIS INTEGRATED PROGRAMMER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED RETURNING THE PROGRAMMER. THIS PROGRAMMER REMAINS IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174343 ↗
• MalfunctionMay 6, 2026Nonstandard Device; Failure to Power Up

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER WAS UNABLE TO POWER UP EVEN IF CHARGING THE BATTERY. BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT ADVISED FOR PRODUCT RETURN. ADDITIONAL INFORMATION INDICATED THAT THE REPORTED ANOMALY WITH THIS PRM WAS RESOLVED. THIS PROGRAMMER WAS OUT OF SERVICE AND RETURNED FOR REPAIR, AND A REPLACEMENT WAS ORDERED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095763 ↗
• MalfunctionMay 4, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS COMMUNICATOR HAD A TOUCH SCREEN UNRESPONSIVE. TECHNICAL SERVICES (TS) REQUESTED TO SEND THE DEVICE BACK FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071955 ↗

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