ZOOM® LATITUDE® 3120 (UDI 00802526582004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00802526582004), received between Oct 9, 2017 and Jun 29, 2018 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 reports).

4 FDA recall records name this device's identifier, 4 still open.

8 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 18, 2026.

Recalls naming this device

1. Nov 30, 2023Class IIOpen, Classified

   The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.

   Z-0673-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 7, 2022Class IIOpen, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1671-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Jul 7, 2022Class IIOpen, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1669-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Jul 7, 2022Class IIOpen, Classified

   There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.

   Z-1670-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2018Failure to Capture; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Failure to Capture; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, AFTER THE END TEST BUTTON WAS PRESSED, THIS PROGRAMMER/RECORDER/MONITOR (PRM) TOOK FOUR SECONDS TO END THE MANUAL LEFT VENTRICULAR (LV) THRESHOLD TEST THAT WAS IN PROGRESS. DURING THIS TIME, THE RESULTING LOSS OF CAPTURE LED TO THE PATIENT HAVING A NEAR-SYNCOPAL EPISODE. PACING INHIBITION OF UP TO THREE SECONDS WAS REPORTED. THIS PRM REMAINS IN SERVICE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED OTHER WAYS TO END TESTING. THIS PRM WAS RETURNED FOR ANALYSIS. THE IMPLANTED SYSTEM REMAINS IN SERVICE.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7650541 ↗
• MalfunctionMar 19, 2018Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER WAS EMITTING SMOKE AND HAD A BURNING SMELL. THE PROGRAMMER IS EXPECTED TO BE RETURNED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7349061 ↗
• MalfunctionJan 30, 2018Failure to Capture; Communication or Transmission Problem; Failure to Capture; Communication or Transmission Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN CLINIC FOLLOW UP, UPON COMPLETION OF THRESHOLD TESTING WITH THIS PACEMAKER AND ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) LEAD, THE END TEST BUTTON WAS SELECTED ON THE PROGRAMMER, HOWEVER, A COUPLE MORE BEATS OF VENTRICULAR PACING WERE OBSERVED WITH NO CAPTURE RESULTING IN GREATER THAN 2 SECONDS OF ASYSTOLE BEFORE THE TEST ACTUALLY ENDED. IT WAS NOTED THAT THE INITIAL TEST WAS PERFORMED USING RADIO FREQUENCY (RF) TELEMETRY. A SECOND THRESHOLD TEST WAS PERFORMED USING WANDED TELEMETRY, HOWEVER, PRODUCED THE SAME RESULT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE TEST STRIP AND DISCUSSED THAT THE END TEST COMMAND WAS LIKELY NOT RECEIVED BY THE DEVICE UNTIL 1-2 SECONDS AFTER THE END TEST BUTTON WAS PRESSED. TS DISCUSSED THAT THIS DELAY IS COMMONLY ASSOCIATED WITH TELEMETRY INTERFERENCE. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7227318 ↗
• MalfunctionJan 5, 2018Device Operates Differently Than Expected; Material Integrity Problem; Problem with Software Installation; Device Operates Differently Than Expected; Material Integrity Problem; Problem with Software Installation

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE FIELD REPRESENTATIVE HAD A PROBLEM LOADING NEW SOFTWARE ON THE PROGRAMMER AND IT THEN WENT BLACK. IT ALSO SMELLED LIKE PLASTIC BURNING. THE PROGRAMMER WAS RETURNED FOR EVALUATION, REPAIRED, AND IS EXPECTED TO BE RETURNED TO THE FIELD. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7168713 ↗
• MalfunctionNov 30, 2017Material Integrity Problem; Material Integrity Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER EMITTED SMOKE. THE SMOKE CAME OUT OF THE FLOPPY DRIVE AREA AND IT SMELLED LIKE HOT ELECTRICAL SMOKE. THE PROGRAMMER WILL BE RETURNED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7070250 ↗
• MalfunctionNov 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER'S SCREEN WENT BLACK AND WAS NO LONGER FUNCTIONING. THE PROGRAMMER WAS REPAIRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7070249 ↗
• MalfunctionNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE FIELD REPRESENTATIVE COULD BARELY OPEN THIS PROGRAMMER. THE PROGRAMMER EXHIBITED PHYSICAL DAMAGE. HOWEVER, THE FIELD REPRESENTATIVE GOT THE PROGRAMMER TO FUNCTION TEMPORARILY. THE PROGRAMMER WAS EVENTUALLY RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7070248 ↗
• MalfunctionNov 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER EXHIBITED ELECTRICAL SHORTAGE AND EMITTED SMOKE. THE PROGRAMMER WILL BE RETURNED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6995742 ↗
• MalfunctionOct 9, 2017Ambient Noise Problem; Device Operates Differently Than Expected; Ambient Noise Problem; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PROGRAMMER EMITTED A GRINDING NOISE AND THEN LOCKED UP A COUPLE OF TIMES. ALSO, LOTS OF PACING SPIKES WERE NOTED ON ELECTROCARDIOGRAM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED RETURNING THE PROGRAMMER. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6933044 ↗

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-1216-2023 · Feb 2, 2023 · Open, Classified
  LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
• 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