LATITUDE™ Programming System 3300 (UDI 00802526610110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00802526610110), received between Jul 13, 2022 and Apr 13, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER EXHIBITED AN UNRESPONSIVE TOUCH SCREEN. THE LOCAL REPRESENTATIVE WOULD RETURN THIS PROGRAMMER FOR REPAIR. AS OF THIS TIME, THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE EVENT OCCURRED DURING AN IMPLANT PROCEDURE. THE ANOMALY WAS RESOLVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865834 ↗
• MalfunctionMar 24, 2025Defective Device; Application Program Problem; Defective Device; Application Program Problem

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER DISPLAYED AN ERROR CODE MESSAGE WHICH WAS HAPPENED SEVERAL TIMES AFTER RESTARTING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) STATED THAT THE CAUSE WAS A HARDWARE ISSUE INVOLVING THE ELECTROCARDIOGRAM (ECG) BOARD. TS DISCUSSED PROGRAMMER MUST BE RETURNED FOR REPAIR. THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE PROGRAMMER EXHIBITED AN ERROR CODE STATING THAT THE PACING SYSTEM ANALYZER (PSA) ENCOUNTERED AN UNRECOVERABLE ERROR AND PACING OUTPUT MAY NOT BE AVAILABLE. REBOOTING WAS PERFORMED; HOWEVER IT WAS NOT SUCCESSFUL. LATER AFTER AN HOUR, THIS PRM HAD NORMAL FUNCTION TO INCLUDE ACCESSING THE PSA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678438 ↗
• MalfunctionFeb 18, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER TOUCHSCREEN IS NOT WORKING AND FREEZING UP. BOSTON SCIENTIFIC REPRESENTATIVE WILL RETURN FOR REPLACEMENT. THIS PROGRAMMER REMAINS IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396843 ↗
• MalfunctionOct 11, 2024Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THE PATIENT WITH A IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS TO UNDERGO A MAGNETIC RESONANCE IMAGING (MRI) SO IT WAS TO BE PROGRAMMED INTO MRI PROTECTION MODE. THE PACEMAKER WAS NOT ABLE TO BE INTERROGATE WITH THE PROGRAMMER, WITH IT DISPLAYING A WAND OUT OF RANGE MESSAGE. TECHNICAL SERVICES (TS) PERFORMED TROUBLESHOOTING, WITH THE ISSUE NOT RESOLVED SO THE CALLER WAS ADVISED TO CONTACT THEIR LOCAL FIELD REPRESENTATIVE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE FIELD INDICATES THE ISSUE WAS RESOLVED, A NEW PROGRAMMER AND A NEW WAND WAS USED AND IT WAS ABLE TO INTERROGATE THE ICD. THE ISSUES WERE ATTRIBUTED TO DAMAGE IN THE WAND. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428957 ↗
• MalfunctionDec 11, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER FAILED TO RESPOND TO TOUCH DURING INTERROGATION AS THE SCREEN WOULD NOT RESPOND. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED TO REBOOT AND TRY AGAIN. CLINICIAN HAS AND THE PROGRAMMING SEEMED TO BE WORKING NOW. THIS PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300940 ↗
• MalfunctionNov 4, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  ALLEGATION OF LATITUDE PROGRAMMING SYSTEM INTERMITTENTLY NOT RECOGNIZING/RESPONDING TO A TOUCHED BUTTON DURING A RIGHT VENTRICULAR THRESHOLD TEST. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070334 ↗
• MalfunctionOct 27, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER TOUCH SCREEN WAS UNRESPONSIVE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED REBOOTING THE PROGRAMMER OR MAY BE A POSSIBLE HARDWARE ISSUE WHICH NEEDS TO BE RETURNED. THE PROGRAMMER REMAINS IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021618 ↗
• MalfunctionMay 31, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER WOULD PERIODICALLY FREEZE AND DID NOT ALLOW ANY INPUT DURING THE CASE. FIELD REPRESENTATIVE REBOOTED THIS PROGRAMMER AND IT SEEMED TO BE FINE. THIS PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17034803 ↗
• MalfunctionMay 31, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT INTEGRATED PROGRAMMER SCREEN FROZE WHEN NEARING END OF THE CASE ANG THE ELECTROGRAM (EGM) IS STILL MOVING ACROSS THE TOP. THE PROGRAMMER WAS REBOOTED AND WORKS FINE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSS POSSIBLE SCREEN HARDWARE ISSUE. THE PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030104 ↗
• MalfunctionMay 18, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER WAS NOT RESPONSIVE. THE PROGRAMMER WAS RESTARTED AND THE ISSUE WAS RESOLVED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955780 ↗
• MalfunctionMay 16, 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 WOULD NOT RESPOND TO TOUCH WHILE INTERROGATING A DEVICE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED TROUBLESHOOTING AND ADVISED TO RETURN THE PROGRAMMER IF IT OCCURS AGAIN. THIS PROGRAMMER WAS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16942513 ↗
• MalfunctionMay 12, 2023Application Program Problem; Key or Button Unresponsive/not Working; Application Program Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT TWO DIFFERENT PROGRAMMERS WERE UNRESPONSIVE TO THE TOUCH OF A FINGER. THIS PROGRAMMER HAD BEEN POWERED ON FOR A DECENT AMOUNT OF TIME WITH NO REAL ACTIVE SESSION ON. THERE WAS NO PATIENT INVOLVEMENT. THE PROGRAMMER NEEDED TO BE POWERED OFF TO REBOOT THEM. THE PROGRAMMER HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924477 ↗
• MalfunctionMay 9, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS LATITUDE 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 16900178 ↗
• MalfunctionMar 17, 2023Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE SCREEN OF THIS PROGRAMMER WAS UNRESPONSIVE DURING VENTRICULAR THRESHOLD TESTING. THE FIELD REPRESENTATIVE WAS ABLE TO BREAK IT BY HITTING THE INTERROGATION ON THE BOTTOM OF THE SCREEN. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566640 ↗
• MalfunctionDec 8, 2022Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE PROGRAMMER'S SCREEN STOPPED RESPONDING WHEN MEASURING THE THRESHOLD OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT. THE PROGRAMMER WILL BE RETURNED FOR REPAIR AND ANALYSIS. NO ADVERSE PATIENT EFFECT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940991 ↗
• MalfunctionJul 13, 2022Display or Visual Feedback Problem; Key or Button Unresponsive/not Working; Display or Visual Feedback Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT DURING THE CASE, AND WHILE RUNNING A THRESHOLD TESTS THE PROGRAMMER FROZE. THE PRODUCT REMAINS IN SERVICE. NO PATIENT INVOLVEMENT INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15006213 ↗

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