LATITUDE™ Programming System 3300 (UDI 00802526620201)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00802526620201), received between May 24, 2023 and Sep 10, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (17 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Nonstandard Device; Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721280 ↗
• MalfunctionMay 27, 2025Pacing Problem; Defective Device; Device Sensing Problem; Key or Button Unresponsive/not Working; Pacing Problem; Defective Device; Device Sensing Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE PACING SYSTEM ANALYZER (PSA) ON THIS INTEGRATED PROGRAMMER WAS UNABLE TO PACE OR SENSE IN NEITHER OF THE PORT. ADDITIONALLY, LEFT VENTRICLE PORT PACE BUT NOISE WAS NOTED AND SCREEN FROZE. TECHNICAL SERVICES (TS) SUGGESTED TO HAVE THE PROGRAMMER BE RETURNED. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090574 ↗
• MalfunctionMay 14, 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 KEEPS ON FREEZING UP. THE PROGRAMMER WILL BE RETURN FOR REPAIR OR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021328 ↗
• MalfunctionApr 17, 2025Defective Device; Application Program Problem; Defective Device; Application Program Problem

  THIS SUPPLEMENTAL REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION REGARDING PRODUCT ANALYSIS. IT WAS REPORTED THAT THIS PROGRAMMER HAD A RED WARNING SCREEN. THIS OCCURRED AFTER EXITING THE SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR SOFTWARE APPLICATION. A DEVICE HAD JUST BEEN SUCCESSFULLY INTERROGATED, AND THE CLINIC WAS CLOSING DOWN THE PROGRAMMER FOR THE DAY. THE LOCAL REPRESENTATIVE TRIED TO INTERROGATE A DIFFERENT DEVICE AND GOT THE SAME WARNING SCREEN. TECHNICAL SERVICES REQUESTED THAT THE PROGRAMMER BE RETURNED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PROGRAMMER WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853572 ↗
• MalfunctionMay 3, 2024Defective Device; Application Program Problem; Interrogation Problem; Key or Button Unresponsive/not Working; Defective Device; Application Program Problem; Interrogation Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER DISPLAYED AN ERROR CODE MESSAGE. ALSO, THIS PROGRAMMER FREEZES AT A TIME AND HAS ISSUE INTERROGATING DEVICE. THIS PROGRAMMER WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19244452 ↗
• MalfunctionApr 24, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER FREEZES AT A TIME. THIS PROGRAMMER WILL BE RETURNED. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176748 ↗
• MalfunctionApr 19, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER SCREEN KEEPS FREEZING UP WHEN PROGRAMMING A DEVICE AND STARTING A HEART CONNECT. THE FIELD REPRESENTATIVE ALREADY TRIED RESTARTING THIS PROGRAMMER BUT ISSUE PERSISTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT INSTRUCTED TO REMOVE CELLULAR ADAPTER UNIVERSAL SERIAL BUS (USB), THEN RESTART AND WENT TO SOFTWARE UPDATES AND DID EASY INSTALL. THEREAFTER, THE ISSUE WAS RESOLVED, AND THE FIELD REPRESENTATIVE WAS ABLE TO INTERROGATE AND PROGRAM AS DESIRED. THIS PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19144410 ↗
• MalfunctionMar 26, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER TOUCH SCREEN WAS UNRESPONSIVE WHEN ATTEMPTING TO EXIT MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE. THE HEALTH CARE PROFESSIONAL (HCP) REBOOTED THE PROGRAMMER, AND THE TOUCH SCREEN FUNCTIONED APPROPRIATELY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) GUIDED THE HEALTH CARE PROFESSIONAL (HCP) TO EXIT MRI PROTECTION AND START THE HEART CONNECT SESSION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE ISSUE WAS RESOLVED. THE PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984016 ↗
• MalfunctionMar 23, 2024Telemetry Discrepancy; Use of Device Problem; Telemetry Discrepancy; Use of Device Problem

  IT WAS REPORTED THAT MANUAL LEFT VENTRICULAR (LV) THRESHOLD TESTING WAS IN PROGRESS AS THE PHYSICIAN WAS CLOSING THE DEVICE POCKET AND COMPLETING THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM IMPLANT PROCEDURE. TELEMETRY WAS LOST FOR A MOMENT, AND APPEARED TO CANCEL THE THRESHOLD TEST. HOWEVER INSTEAD OF RETURNING TO THE LV THRESHOLD TEST SCREEN, THE THRESHOLD TEST CONTINUED IN THE BACKGROUND. THE FIELD REPRESENTATIVE ATTEMPTED TO START A NEW TEST IN ORDER TO INTERRUPT THE ONGOING THRESHOLD TEST AS THERE WAS LV LOSS OF CAPTURE (LOC), BUT WAS UNSUCCESSFUL. THE PROGRAMMER INDICATED THAT A TEST COULD NOT BE PERFORMED BECAUSE THE CURRENT DIAGNOSTIC TEST WAS UNDERWAY. UPON FURTHER INVESTIGATION, THE FIELD REPRESENTATIVE WAS ABLE TO REPRODUCE THIS OBSERVATION. WHEN STARTING A THRESHOLD TEST WITH MARGINAL TELEMETRY AND NO LOSS OF TELEMETRY FOR GREATER THAN 2 SECONDS, PRESS THE "END TEST" BUTTON AND START ANOTHER THRESHOLD TEST. WHILE MAINTAINING MARGINAL TELEMETRY THROUGHOUT, THE RIGHT TIMING SEQUENCE CREATES AN OVERLAY OF THE ORIGINAL TEST AND PREVENTS THE TEST FROM ENDING. IF TELEMETRY HAD BEEN INTERRUPTED FOR GREATER THAN TWO SECONDS, OR IF EITHER STAT DIVERT OR S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965854 ↗
• MalfunctionFeb 11, 2024Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER TOUCH-SCREEN KEYBOARD WAS NOT WORKING PROPERLY THAT COULD NOT SELECT THE DESIRED KEY WHEN TAPPING THE KEYBOARD TO ENTER DATA. ADDITIONAL INFORMATION INDICATED THAT THE PROGRAMMER WAS RETURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682786 ↗
• MalfunctionJan 12, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE SCREEN OR KEYPAD OF THIS PROGRAMMER WAS NOT FUNCTIONAL. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE SCREEN WAS UNRESPONSIVE. THIS PROGRAMMER WAS RETURNED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501420 ↗
• MalfunctionDec 13, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PROGRAMMER WAS RETURNED TO BOSTON SCIENTIFIC WITHOUT ANY REPORTED ALLEGATIONS AGAINST ITS FUNCTIONALITY OR INVOLVEMENT WITH ANY ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS IDENTIFIED A PRODUCT PERFORMANCE ISSUE AND DETAILED TESTING WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319757 ↗
• MalfunctionSep 21, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER WAS BROKEN. THE PROGRAMMER SCREEN WORKS WHEN CHECKING THE DEVICE, BUT TOUCHSCREEN DOES NOT RESPOND. THERE IS NO FURTHER INFORMATION AVAILABLE TO DATE AND THE DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION INDICATED THAT THE ISSUE WAS RESOLVED HOWEVER, THE PROGRAMMER WAS RETURNED, AND A NEW PROGRAMMER WAS REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787636 ↗
• MalfunctionJun 7, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE PROGRAMMER TOUCH SCREEN WAS NOT RESPONDING. THE PRODUCT WAS RETURNED FOR ANALYSIS/REPAIR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078010 ↗
• MalfunctionJun 2, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE TOUCHSCREEN OF THIS PROGRAMMER WAS DAMAGED. THE PROGRAMMER WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050193 ↗
• MalfunctionJun 2, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE TOUCHSCREEN OF THIS PROGRAMMER WAS UNRESPONSIVE. THIS PROGRAMMER WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050016 ↗
• MalfunctionJun 1, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE TOUCHSCREEN OF THIS PROGRAMMER GOT LOCKED FEW TIMES. THE PROGRAMMER WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042273 ↗
• MalfunctionJun 1, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE TOUCHSCREEN OF THIS PROGRAMMER WAS DAMAGED. THE PROGRAMMER WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039850 ↗
• MalfunctionJun 1, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE TOUCHSCREEN OF THIS PROGRAMMER WAS UNRESPONSIVE. THE PROGRAMMER WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039394 ↗
• MalfunctionMay 31, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE TOUCHSCREEN OF THIS PROGRAMMER WAS UNRESPONSIVE. THIS PROGRAMMER WAS OUT OF SERVICE AND RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030805 ↗
• MalfunctionMay 31, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE TOUCHSCREEN OF THIS PROGRAMMER WAS FROZEN AND UNRESPONSIVE. THIS PROGRAMMER WAS OUT OF SERVICE AND RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030458 ↗
• MalfunctionMay 24, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER HAD AN UNRESPONSIVE TOUCHSCREEN. THE PROGRAMMER WAS POWER CYCLED SEVERAL TIMES WHICH DID NOT RESOLVE THE ISSUE. THE PROGRAMMER WAS TO BE USED ON A PATIENT WHO HAD FALLEN FROM A LATTER AND WENT INTO VENTRICULAR FIBRILLATION (VF) ARREST. THE VF ARREST WAS UNRELATED TO THE PROGRAMMER AND THE PATIENT AT THE TIME HAD A PACEMAKER IMPLANTED WHICH COULD NOT PROVIDE TACHY THERAPY TO RESTORE NORMAL SINUS RHYTHM. TWO YEARS LATER THE PROGRAMMER WAS RETURNED FOR EVALUATION. THIS PROGRAMMER WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY; FUNCTIONAL TESTING AND BASELINE CHECKS WERE COMPLETED. VISUAL INSPECTION REVEALED CHIPPED GLASS ON TOUCHSCREEN AND WAS DAMAGED. THE PROGRAMMER WAS POWERED ON AND THE LOGFILE WAS DOWNLOADED. ERROR CODE A0EA4D WAS FOUND DURING BASELINE INTERROGATION, RELATED TO A SOFTWARE ISSUE. THE SOFTWARE APPLICATION WAS RELOADED AND THE ERROR DISAPPEARED. 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 LATITUD

  Patient problems: Insufficient Information

  MAUDE report 16998176 ↗

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