LATITUDE™ Programming System 3300 (UDI 00802526608513)Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00802526608513), received between Jul 15, 2020 and Jul 1, 2026 — classified as 72 malfunctions.

The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (57 reports).

10 other recalls cover devices cleared under the same FDA submission (P910077); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJan 28, 2026Application Program Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT DURING A HEARTCONNECT SESSION, THE FIELD REPRESENTATIVE REPORTED THAT THIS PROGRAMMER BECAME UNRESPONSIVE AND CODE FC588 WAS DISPLAYED. TECHNICAL SERVICES (TS) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE PROVIDED DATA WAS ANALYZED AND THE CODE FC588 WAS NOT OBSERVED. TS ADVISED THE FIELD REPRESENTATIVE TO UPDATE THE SOFTWARE AND REBOOT THE PROGRAMMER. AT THIS TIME, THE PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR PRODUCT ANALYSIS BECAUSE THE USER WAS ABLE TO RESOLVE THE ISSUE AND THE PROGRAMMER REMAINS IN SERVICE AT THE HEALTHCARE FACILITY. ALTHOUGH THE DEVICE WAS NOT RETURNED FOR ANALYSIS, BOSTON SCIENTIFIC PERFORMED AN INVESTIGATION WITH ALL AVAILABLE INFORMATION. AN UNRESPONSIVE TOUCHSCREEN IS A KNOWN AND ANTICIPATED POTENTIAL HAZARD THAT CAN OCCUR DURING USE OF THE DEVICE WHICH IS ACCOUNTED FOR IN DEVICE RISK DOCUMENTATION AND LABELING. BOSTON SCIENTIFIC HAS RECEIVED SIMILAR REPORTED EVENTS WHERE THE LATITUDE PROGRAMMER SCREEN BECAME UNRESPONSIVE TO TOUCH, AND A COMPLAINT REVIEW CONFIRMED THAT THE OCCURRENCE OF HARM ASSOCIATED WITH THESE EVENTS IS LOW. INVESTIGATION OF THIS BEHAVIOR HAS NOT FOUND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201821 ↗
• MalfunctionNov 25, 2025Application Program Problem; Interrogation Problem; Application Program Problem; Interrogation Problem

  IT WAS REPORTED THAT THE PACEMAKER WAS UNABLE TO BE INTERROGATED BY THIS PROGRAMMER. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING STEPS TO THE HEALTH CARE PROFESSIONAL (HCP), BUT THE DEVICE STILL COULDN'T BE INTERROGATED. A "STOP WHEN READING DATA," MESSAGE APPEARED ON THIS PROGRAMMER. TS SUSPECTED THE PACEMAKER HASN'T BEEN UPDATED WITH THE LATEST SOFTWARE UPDATE, WHICH MAY BE CAUSING THE INTERROGATION ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645792 ↗
• MalfunctionNov 20, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE TOUCH SCREEN FROZE ON THIS INTEGRATED PROGRAMMER. THE FIELD REPRESENTATIVE REBOOTED THE INTEGRATED PROGRAMMER AND THIS RESOLVED THE ISSUE. THIS INTEGRATED PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609256 ↗
• MalfunctionNov 17, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS PROGRAMMER HAD SOMETHING STUCK IN THE CHARGING PORT WHICH COULD NOT BE CHARGED AND SPARKED WHEN TRIED TO PLUG WITH ANYTHING IN. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED FOR THIS PROGRAMMER TO BE RETURNED. AS OF THIS TIME, THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576592 ↗
• MalfunctionNov 11, 2025Application Program Problem; Key or Button Unresponsive/not Working; Application Program Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER EXHIBITED RECURRENT ERROR CODES. IN ADDITION, THE FIELD REPRESENTATIVE REPORTED THIS INTEGRATED PROGRAMMER SHUT DOWN DURING A THRESHOLD TEST. AS A RESULT, THE THRESHOLD TEST WAS FORCIBLY TERMINATED. THE FIELD REPRESENTATIVE PROVIDED THIS INTEGRATED PROGRAMMER WOULD BE RETURNED AND REPAIRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523876 ↗
• MalfunctionSep 18, 2025Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER EXHIBITED A SCREEN ISSUE, IT WAS UNRESPONSIVE. THE PROGRAMMER WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083063 ↗
• MalfunctionMar 17, 2025No Display/Image; Defective Device; No Display/Image; Defective Device

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER WAS SHOWING BLUE ON THE SCREEN. AS OF THIS TIME, THIS PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615669 ↗
• MalfunctionMar 14, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER HAS HAD THE SCREEN FREEZE MULTIPLE TIMES AND REQUIRES RESTART. TECHNICAL SERVICES RECOMMENDED RETURNING THE PROGRAMMER FOR REPAIR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PROGRAMMER WAS LATER RETURNED AND ANALYZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607507 ↗
• MalfunctionJan 9, 2025Failure to Charge; Defective Device; Failure to Charge; Defective Device

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER NO LONGER CHARGING. THE FIELD REPRESENTATIVE TESTED DIFFERENT POWER CORDS AND, LACKED AN ALTERNATIVE BATTERY FOR TESTING, ATTEMPTED REMOVING AND REINSERTING THE EXISTING BATTERY. THE FIELD REPRESENTATIVE COMPLETED A DEVICE CHECK BUT REMAINED UNCERTAIN ABOUT THE DEVICE'S RELIABILITY. THE REPRESENTATIVE'S MANAGER HAD ALREADY REQUESTED A REPLACEMENT. THIS PROGRAMMER WAS RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114764 ↗
• MalfunctionAug 7, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER DISPLAYED FROZEN SCREEN. THE SALES REPRESENTATIVE REQUESTED TWO UNITS FOR REPLACEMENT. THE PROGRAMMER REMAINS IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934180 ↗
• MalfunctionJun 13, 2024Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER TOUCHSCREEN WAS UNRESPONSIVE. THIS PROGRAMMER REMAINS IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532995 ↗
• MalfunctionMay 7, 2024Defective Device; Intermittent Loss of Power; Defective Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THIS PROGRAMMER TURNED OFF SUDDENLY WHILE ATTEMPTING TO INTERROGATE A DEVICE. NO ERROR CODES WERE DISPLAYED ON THE SCREEN. THE BATTERY HAD ALREADY BEEN REPLACED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED RETURNING THIS PROGRAMMER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19265397 ↗
• MalfunctionApr 30, 2024Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE TOUCHSCREEN OF THE PROGRAMMER WAS NOT RESPONDING DURING INITIAL POWERUP, AND THEN THE PROGRAMMER FROZE UP DURING AN LEFT VENTRICULAR (LV) THRESHOLD TEST. TECHNICAL SERVICES (TS) WAS CONTACTED, AND TS RECOMMENDED REPLACING THE PROGRAMMER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211786 ↗
• MalfunctionApr 29, 2024Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS LATITUDE PROGRAMMING SYSTEM WAS BEING USED FOR A THRESHOLDS TEST AND THE TEST SCREEN FROZE AT A LOSS OF CAPTURE VALUE. THEY COULD NOT PRESS ANY BUTTONS TO CHANGE THE SCREEN. THE PROGRAMMER WAS REBOOTED TO GET OUT OF THE THRESHOLD SCREEN SO THE PROGRAMMER WILL BE REMOVED FROM THIS FACILITY AND REPLACED. THE PATIENT WAS NOT DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200561 ↗
• MalfunctionDec 19, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER TOUCH SCREEN WAS LESS RESPONSIVE IN COLD WEATHER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED KEEPING THE PROGRAMMER IN THE OPERATING TEMPERATURE RANGE. THE PROGRAMMER TOUCH SCREEN STARTS WORKING ABOUT 15MINUTES AFTER COMING IN AND WARMING UP. THE PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354739 ↗
• MalfunctionDec 7, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE SCREEN ON THIS INTEGRATED PROGRAMMER IS NOT RESPONDING WELL. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE ISSUE WAS NOT RESOLVED AND PROGRAMMER WILL BE RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281916 ↗
• MalfunctionNov 7, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT DURING A PACING SYSTEM ANALYZER (PSA) TEST WHILE PERFORMING AN IMPLANT PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTIES OPERATING THIS PROGRAMMER. THE PHYSICIAN NOTED THAT THE PROGRAMMER DISPLAY SCREEN WAS INTERMITTENTLY UNRESPONSIVE TURNING OFF AND ON DURING A THRESHOLD TEST. TECHNICAL SERVICES (TS) RECOMMENDED TO THE PHYSICIAN TO USE A DIFFERENT PROGRAMMER TO RULE OUT POSSIBLE ELECTROMAGNETIC INTERFERENCE (EMI). THE PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089151 ↗
• MalfunctionJul 17, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PROGRAMMER HAD AN ISSUE WITH THE UNIVERSAL SERIAL BUS (USB) PORTS. ADDITIONALLY, THE USBS WERE LITERALLY FRYING, AND THE FIELD REPRESENTATIVE GOT A SMALL BURN WHEN REMOVING A USB DRIVE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED THAT THE PROGRAMMER SHOULD BE RETURNED FOR REPLACEMENT. THIS PROGRAMMER WAS ENROUTE FOR RETURN. NO PATIENT INVOLVEMENT NOTED.

  Patient problems: Burn(s)

  MAUDE report 17335214 ↗
• MalfunctionJul 13, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER HAD A FROZEN SCREEN. RECYCLING POWER RESOLVED THE ISSUE AND BROUGHT UP THE MAIN SCREEN. THIS PROGRAMMER REMAINS IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317142 ↗
• MalfunctionJun 12, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE TOUCH SCREEN OF THIS PROGRAMMER BECAME UNRESPONSIVE. THIS PROGRAMMER WILL BE SENT BACK, AND NO REPLACEMENT WAS REQUESTED. THERE WAS NO PATIENT INVOLVEMENT NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107978 ↗
• MalfunctionJun 12, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE TOUCH SCREEN IS THIS PROGRAMMER WAS UNRESPONSIVE EVEN IF IT WAS REBOOTED MULTIPLE TIMES. THIS PROGRAMMER WILL BE RETURNED AND NEW ONE WAS ORDERED. THERE WAS NO PATIENT INVOLVEMENT NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107896 ↗
• MalfunctionJun 5, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE TOUCHSCREEN ON THIS PROGRAMMER BECAME UNRESPONSIVE. THIS HAD OCCURRED MORE THAN ONCE WITH THIS UNIT. DURING ONE INSTANCE, THE DEVICE HAD TO BE REINTERROGATED WITH A WAND TO PROCEED WITH THE CASE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PROGRAMMER WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17066821 ↗
• MalfunctionMay 31, 2023Pacing Problem; Key or Button Unresponsive/not Working; Pacing Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER WAS SUSPECTED FOR MALFUNCTION AND FUNCTION FREEZING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED PROGRAMMER REBOOT. THE PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030531 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P910077. One submission often covers many models, so check the product and lot details in each record.

• Z-0673-2024 · Nov 30, 2023 · Open, Classified
  Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: AL
• Z-1216-2023 · Feb 2, 2023 · Open, Classified
  LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
• Z-1669-2022 · Jul 7, 2022 · Open, Classified
  The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The
• Z-3260-2018 · Sep 10, 2018 · Terminated
  Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communic
• Z-1445-2012 · Feb 24, 2012 · Terminated
  Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, Made in Malaysi
• Z-1096-2012 · Dec 19, 2011 · Terminated
  LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transf
• Z-0333-2012 · Oct 12, 2011 · Terminated
  LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system
• Z-0037-2012 · Aug 12, 2011 · Terminated
  LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software ver
• Z-1631-2010 · Sep 10, 2009 · Terminated
  Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112. Models 6476 (USA) and 6468 (OUS)
• Z-0002-2007 · May 19, 2006 · Terminated
  Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable p