LATITUDE™ Programming System 3300 (UDI 00802526610202)Recalls & reported problems

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 00802526610202), received between Nov 1, 2020 and Sep 15, 2026 — classified as 3 injuries, 138 malfunctions.

The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (106 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 141 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 15, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER FROZE WHEN TRYING TO EXIT A DEVICE OUT OF THE MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE. SUBSEQUENTLY, IT WAS STATED THAT THE HEALTH CARE PROFESSIONAL (HCP) PERFORMED A POWER CYCLE AND THE DEVICE WAS ABLE TO BE TAKEN OUT OF THE PROTECTION MODE. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24880949 ↗
• MalfunctionApr 1, 2026Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER STARTED SMOKING DUE TO GLYCOL PIPE LEAK. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED RETURN OF PROGRAMMER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761377 ↗
• MalfunctionFeb 12, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE INTEGRATED PROGRAMMER SCREEN WAS LOCKED UP AND DID NOT RESPOND DURING INTERROGATIONS BUT WAS CORRECTED WITH POWER CYCLE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED DEVICE TO BE RETURNED. THIS PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319878 ↗
• MalfunctionDec 29, 2025No Display/Image; Date/Time-Related Software Problem; Application Program Problem; No Display/Image; Date/Time-Related Software Problem; Application Program Problem

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER DISPLAYED BLACK SCREEN DURING THE PACING SYSTEM ANALYZER USE IN A CASE AND EXHIBITED COMPLEMENTARY METAL-OXIDE SEMICONDUCTOR (CMOS) ANOMALY. BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED TROUBLESHOOTING ON CMOS AND ADVISED TO SEND FOR REPAIR IF RECURS. AS OF THIS TIME, THIS PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATES THAT THE SCREEN ANOMALY EXHIBITED PRIOR TO ANY IMPLANTABLE LEADS BEING INTRODUCED. THE PROGRAMMER WAS REBOOTED, RESOLVED, AND OPERATED NORMALLY. THIS PROGRAMMER WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905888 ↗
• MalfunctionNov 26, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THIS PROGRAMMER SCREEN WAS UNABLE TO LIGHT UP. THE SCREEN STAYED BLACK AND WENT SYSTEM POWER OFF. IN ADDITION, THE FIELD REPRESENTATIVE MADE SURE ALL THE CONNECTIONS WERE GOOD WITH POWER SOURCE AND RETRIED BOOT UP, HOWEVER, THE ISSUE STILL PERSISTS. PROGRAMMER REPLACEMENT WAS RECOMMENDED. THIS PROGRAMMER WAS OUT OF SERVICE AND RETURNED FOR ANALYSIS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663023 ↗
• MalfunctionNov 21, 2025Nonstandard Device; Key or Button Unresponsive/not Working; Nonstandard Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER WAS NOT RESPONDING TO THE TOUCH SCREEN. THE FIELD REPRESENTATIVE CONFIRMED THIS INTEGRATED PROGRAMMER TURNED ON BUT WAS NOT RESPONSIVE. THE FIELD REPRESENTATIVE REPORTED IT APPEARS THE SCREEN WAS CLEANED INAPPROPRIATELY. TECHNICAL SERVICES ADVISED THE INTEGRATED PROGRAMMER WOULD NEED TO BE RETURNED FOR REPAIR. ADDITIONAL INFORMATION PROVIDED THE PROGRAMMER WAS RETURNED FOR REPAIR. THE PHYSICIAN AGREED TO WAIT FOR A REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624919 ↗
• MalfunctionOct 22, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER SCREEN WAS UNRESPONSIVE WHILE ATTEMPTING TO PROGRAM OR END A PROGRAMMING SESSION. A FIELD REPRESENTATIVE WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THIS PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356278 ↗
• InjuryOct 17, 2025Use of Device Problem; Key or Button Unresponsive/not Working; Use of Device Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT DURING PROGRAMMER INTERROGATION OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, LOSS OF CAPTURE (LOC) WAS OBSERVED DURING RIGHT VENTRICULAR (RV) THRESHOLD TESTING FOR THIS PACER DEPENDENT PATIENT. THE HEALTH CARE PROFESSIONAL (HCP) ATTEMPTED TO END THE TEST, BUT WAS UNSUCCESSFUL. SUBSEQUENTLY, THE PATIENT EXPERIENCED APPROXIMATELY 10 SECONDS OF ASYSTOLE AND NEARLY PASSED OUT. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND POSSIBLE CAUSES, NOTING THAT THE SCREEN WAS UNRESPONSIVE OR THERE WAS POOR TELEMETRY. THE HCP PERFORMED DEMO TESTING AND PRESSED AROUND THE PROGRAMMER SCREEN. THE PROGRAMMER WAS RESPONSIVE, WHICH SUGGESTED THERE WAS LIKELY A POOR TELEMETRY CONNECTION WHERE THE COMMAND FROM THE PROGRAMMER WAS NOT RECOGNIZED BY THE CRT-D. THIS PROGRAMMER REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROGRAMMER WAS FUNCTIONING AS EXPECTED THE FOLLOWING AS EXPECTED THE FOLLOWING DAY. IT WAS SUSPECTED THAT THE ISSUE WAS HAVING TWO SETS OF HANDS ON THE PROGRAMMER AT THE SAME TIME, WHICH WOULD NOT ALLOW THE PROGRAMMER TO ACKNOWLEDGE TAPPING THE BUTTON T

  Patient problems: Asystole; Presyncope

  MAUDE report 23331066 ↗
• MalfunctionSep 18, 2025No Display/Image; Key or Button Unresponsive/not Working; No Display/Image; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER WHILE INTERROGATING AND LEAD THRESHOLD TESTING ONE HALF OF THE SCREEN WENT BLACK AND THE OTHER HALF WAS KIND OF FROZEN. IT WAS SUSPECTED TO BE RELATED TO THE SOFTWARE THAT WAS NOT ELICITING THE PACEMAKER-BASED APPLICATION ON THE SCREEN. TECHNICAL SERVICES (TS) RECOMMENDED RETURN OF PROGRAMMER FOR REPAIR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PROGRAMMER WAS ALREADY RETURNED TO BOSTON SCIENTIFIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23091372 ↗
• MalfunctionJul 24, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER SCREEN WAS FROZEN, WHICH OCCURRED AFTER THE PRINT AT THE END OF THE CASE. IN ADDITION, THE PROGRAMMER SYSTEM DETECTED CONDITION THAT REQUIRED AN APPLICATION EXIT SCREEN. FIELD REPRESENTATIVE WILL THEN PERFORM BASIC TROUBLESHOOTING. AS OF THIS TIME, THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586336 ↗
• MalfunctionJul 18, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT DURING A LEFT VENTRICULAR (LV) LEAD THRESHOLD TEST, THIS PROGRAMMER WOULD INITIATE THE THRESHOLD TEST AND WOULD NOT BE RESPONSIVE TO THE COMMANDS. TECHNICAL SERVICES WAS CONSULTED AND ADVISED ON PERFORMING A LIVE SESSION TO FURTHER INVESTIGATE THIS BEHAVIOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PROGRAMMER REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543597 ↗
• MalfunctionJul 7, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT WHEN ATTEMPTING TO EXIT MRI PROTECTION MODE, THE PROGRAMMER DISPLAYED AN HOURGLASS AND WOULD NOT COMMUNICATE FURTHER. THE PROGRAMMER WAS POWER CYCLED, AND IT WAS THEN POSSIBLE TO EXIT THE MODE. TECHNICAL SERVICES CONFIRMED PROPER DEVICE FUNCTION FOLLOWING THE EXIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22415595 ↗
• MalfunctionJun 19, 2025Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT TOUCH SCREEN OF THIS PROGRAMMER WAS UNRESPONSIVE. THE PROGRAMMER WILL BE SENT BACK FOR REPAIR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292125 ↗
• MalfunctionMay 14, 2025Application Program Problem; Key or Button Unresponsive/not Working; Application Program Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER EXHIBITED A SYSTEM ISSUE DURING EC UPGRADE, IT WAS UNABLE TO CONNECT TO BSC UPDATE SERVER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMEND RETURNING PROGRAMMER FOR REPAIRS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021108 ↗
• MalfunctionMay 8, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER EXHIBITED AN UPDATE ISSUE, TOUCH SCREEN DOESN'T RESPOND. TROUBLESHOOTING WAS PERFORMED AND WAS RESOLVED. THE PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991033 ↗
• MalfunctionMar 27, 2025Display or Visual Feedback Problem; Defective Device; Display or Visual Feedback Problem; Defective Device

  IT WAS REPORTED THAT WHEN UPDATING THE PROGRAMMER, IT WAS UNABLE TO CLICK THE 'PERFORM SYSTEM UPGRADE'. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. AS OF THIS TIME, THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704977 ↗
• MalfunctionJan 21, 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 TOUCH SCREEN ISSUE. BOSTON SCIENTIFIC TECHNICAL SERVICE (TS) ASSISTED IN TROUBLESHOOTING BUT WAS UNRESOLVED. 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 21200793 ↗
• MalfunctionDec 19, 2024Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER'S SCREEN WAS FROZEN IN AN ATTEMPT TO UPDATE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED CALLER FOR TROUBLESHOOTING, HOWEVER, WAS NOT RESOLVED. THIS PROGRAMMER REMAINS IN SERVICE AND WILL BE FOR RETURN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20977293 ↗
• MalfunctionNov 25, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER EXHIBITED A NONFUNCTIONAL TOUCH SCREEN. PROGRAMMER REPLACEMENT WAS RECOMMENDED. ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT THE PROGRAMMER WAS RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771481 ↗

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