LATITUDE™ Programming System 3300 (UDI 00802526616105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00802526616105), received between Aug 15, 2022 and Aug 11, 2026 — classified as 57 malfunctions.

The most frequently reported specific device problem is “Defective Device” (41 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Nonstandard Device; Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216511 ↗
• 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 ↗
• MalfunctionFeb 5, 2026Display or Visual Feedback Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER HAS A BROKEN TOUCHSCREEN AND WAS UNRESPONSIVE. TO DATE, THIS PROGRAMMER REMAINS IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267821 ↗
• MalfunctionDec 22, 2025Nonstandard Device; Key or Button Unresponsive/not Working; Nonstandard Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE RIGHT SIDE OF THE PROGRAMMER SCREEN DOES NOT WORK, IT WAS BLACKED OUT AND WOULD NOT RESPOND TO TOUCH. THE ISSUE WAS DISCOVERED OUT OF THE BOX. PROGRAMMER WAS SHIPPED FROM IN-HOUSE AND NOT USED IN THE FIELD. THE PROGRAMMER WILL BE RETURN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865386 ↗
• MalfunctionJun 30, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER EXHIBITED A SCREEN ISSUE, IT WAS UNRESPONSIVE. BOSTON SCIENTIFIC TECHNICAL SERVICE (TS) ASSISTED IN TROUBLESHOOTING BUT WAS UNRESOLVED. THE PROGRAMMER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22362407 ↗
• MalfunctionMar 11, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER TOUCH SCREEN WAS NOT RESPONDING. RECOMMENDED RETURN AND REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21579555 ↗
• MalfunctionFeb 20, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE BATTERY BUTTON ON THE SCREEN WAS NON-RESPONSIVE. BOSTON SCIENTIFIC TECHNICAL SERVICE (TS) ASSISTED AND DISCUSSED THAT CERTAIN AREA OF SCREEN MAY HAVE GONE BAD. THE PROGRAMMER WILL BE RETURNED FOR REPLACEMENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424953 ↗
• MalfunctionFeb 11, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER TOUCHSCREEN STOPPED RESPONDING. 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 21361049 ↗
• MalfunctionFeb 6, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT THIS PROGRAMMER REVEALED A MESSAGE STATING THE PACING SYSTEM ANALYZER (PSA) HAD ENCOUNTERED AN UNRECOVERABLE ERROR. THE FIELD REPRESENTATIVE (REP) NOTED THIS WAS IN A CASE IN WHICH THE PROGRAMMER WAS JUST GETTING READY TO PACE. THE REP SWITCHED TO A DIFFERENT PROGRAMMER AND THERE WAS NO HARM TO THE PATIENT. TECHNICAL SERVICES (TS) DISCUSSED CONSIDERING REDOING THE ENHANCED CONNECTIVITY UPDATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327203 ↗
• MalfunctionFeb 6, 2025Defective Device; Defective Device

  THIS DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC WITHOUT ANY FIELD ALLEGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324128 ↗
• MalfunctionNov 21, 2024Defective Device; Application Program Problem; Defective Device; Application Program Problem

  IT WAS REPORTED THAT THIS PROGRAMMER DISPLAYED AN ERROR CODE. NO PATIENT INVOLVEMENT WAS REPORTED. THE PROGRAMMER WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754144 ↗
• MalfunctionNov 21, 2024Defective Device; Application Program Problem; Defective Device; Application Program Problem

  IT WAS REPORTED THAT THIS PROGRAMMER DISPLAYED AN ERROR CODE. NO PATIENT INVOLVEMENT WAS REPORTED. THE PROGRAMMER WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754021 ↗
• MalfunctionOct 7, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER SCREEN WAS NOT RESPONDING, BUT HEALTHCARE PROFESSIONAL (HCP) WAS ABLE TO PROCEED WITH MAGNETIC RESONANCE IMAGING (MRI) PROGRAMMING. FURTHERMORE, THE LOCAL REPRESENTATIVE WILL REPLACE THIS PROGRAMMER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383231 ↗
• MalfunctionMay 28, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER'S TOUCHSCREEN FROZE UP SPORADICALLY. IN SOME INSTANCES, THE TOUCHSCREEN FROZE DURING A THRESHOLD TEST. THE THRESHOLD TEST WAS NOT ABLE TO END. THE PROGRAMMER WAS TURNED OFF AND REBOOTED, WHICH WOULD RESOLVE THE ISSUE. IT WAS NOTED THAT THIS EVENT OCCURRED IN VARIOUS CLINICS. THE PROGRAMMER IS EXPECTED TO BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19405959 ↗
• MalfunctionMay 2, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE PROGRAMMER SCREEN WAS INTERMITTENTLY NOT RESPONDING TO TOUCH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED NOT TO TOUCH THE SCREEN WHEN REBOOTING AS IT COULD AFFECT THE SCREEN LATER AND MAKE IT UNRESPONSIVE. A DIFFERENT WANT IS ALSO POSSIBLE TO TRY. AS OF THIS TIME, THE PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229089 ↗
• MalfunctionMar 7, 2024Defective Device; Application Program Problem; Key or Button Unresponsive/not Working; Defective Device; Application Program Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER WAS HAVING ISSUES WHEN PERFORMING SOFTWARE UPDATE, THE SCREEN WOULD NOT TAP A ON MULTI AREAS. THIS PROGRAMMER WILL BE RETURN FOR REPAIR. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854977 ↗
• MalfunctionJan 31, 2024Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT WHILE USING THE PACING SYSTEM ANALYZER (PSA) PROGRAMMER FUNCTION WHILE CONNECTED TO AN IMPLANTABLE DEVICE THAT WAS IN STORAGE MODE, THE PROGRAMMER BECAME UNRESPONSIVE AND THE PROGRAMMER SCREEN FROZE WHEN ATTEMPTING TO TOGGLE OUT OF PSA BACK TO THE DEVICE. THE PROGRAMMER WAS MANUALLY SHUTDOWN AND RESTARTED, HOWEVER THE SCREEN WAS STILL UNRESPONSIVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THE PROGRAMMER WAS RETURNED FOR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18620133 ↗
• MalfunctionOct 8, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE CLOSE TAB SCREEN ON THIS INTEGRATED PROGRAMMER WAS UNRESPONSIVE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED TO GET ANEW PROGRAMMER. THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17892661 ↗
• MalfunctionOct 2, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE TOUCH SCREEN ON THIS INTEGRATED PROGRAMMER WAS NOT WORKING AT TIMES DURING THRESHOLD TESTS. THIS PROGRAMMER WILL BE RETURNED FOR REPAIR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852342 ↗
• MalfunctionSep 20, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE SCREEN ON THIS INTEGRATED PROGRAMMER WAS UNRESPONSIVE WHENEVER THE REPRESENTATIVE WOULD TAP THE SCREEN. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED TO HAVE THIS PROGRAMMER BE REPLACED. THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781001 ↗
• MalfunctionJul 31, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS INTEGRATED PROGRAMMER HAVING SCREEN LOCK UP. THE PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PROGRAMMER WAS RETURNED TO THE LABORATORY ALLEGATION HAS NOT BEEN CONFIRMED BY TESTING OR ANALYSIS, HOWEVER THE PROGRAMMER WAS SUSPECTED TO HAVE A PRODUCT PERFORMANCE ANOMALY DUE TO UNRESPONSIVE SCREEN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423674 ↗
• MalfunctionJul 10, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THIS PROGRAMMER WAS UNRESPONSIVE TO TOUCH AS THE TOUCH SCREEN FREEZES. ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THAT THE ISSUE DID NOT OCCUR DURING IMPLANT PROCEDURE. THIS PROGRAMMER REMAINS IN SERVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288990 ↗
• MalfunctionJul 5, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED, THAT THE SCREEN OF THIS PROGRAMMER HAS FROZEN. THIS PROGRAMMER WAS RETURNED. NO PATIENT INVOLVEMENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258777 ↗
• MalfunctionJun 22, 2023Defective Device; Key or Button Unresponsive/not Working; Defective Device; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE SCREEN ON THIS INTEGRATED PROGRAMMER FREEZES IN THE MIDDLE OF INTERROGATION. THE PROGRAMMER WILL BE RETURNED FOR REPAIR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181475 ↗
• MalfunctionJun 12, 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 AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105989 ↗

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