Boston Scientific Corporation Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus. ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus. ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
All serial numbers. GTIN numbers in the U.S.: 00802526434723, 00802526456961, 00802526467653, 00802526468582, 00802526473449, 00802526474859, 00802526475788, 00802526477676, 00802526478239, 00802526479663, 00802526480638, 00802526484599, 00802526486906, 00802526494406, 00802526497605, 00802526516009, 00802526523212, 00802526535406, 00802526554209, 00802526562600, 00802526564703, 00802526575303, 00802526579707, 00802526582004, 00802526602900, 00802526604584, 00802526606366, 00802526606403, and 00802526611322. GTIN numbers OUS: 00802526435430, 00802526468582, 00802526479663, 00802526480638, 00802526486906, 00802526478246, 00802526479670, 00802526484605, 00802526486913, 00802526496608, 00802526496615, 00802526506703, 00802526515903, 00802526517112, 00802526526602, 00802526527609, 00802526554803, 00802526561900, 00802526564802, 00802526574801, 00802526579905, 00802526582011, 00802526602917, 00802526605406, 00802526606342, 00802526611308, 00802526615603, 00802526437458, 00802526441974, 00802526444814, 00802526467288, 00802526469343, 00802526475450, 00802526475757, 00802526477669, 00802526478253, 00802526479687, 00802526484612, 00802526486920, 00802526496622, 00802526496639, 00802526515910, 00802526517136, 00802526526800, 00802526527616, 00802526554810, 00802526564819, 00802526574818, 00802526581021, 00802526582028, 00802526605437, 00802526606311, 00802526612428, 00802526615634, 00802526454301, 00802526467295, 00802526469350, 00802526475467, 00802526475764, 00802526477676, 00802526484803, 00802526486081, 00802526486937, 00802526497629, 00802526515927, 00802526532832, 00802526557002, 00802526565427, 00802526582301, 00802526587405, 00802526602924, 00802526606359, 00802526612442, 00802526445262, 00802526454950, 00802526474170, 00802526475474, 00802526475771, 00802526480652, 00802526486944, 00802526497643, 00802526517174, 00802526526817, 00802526527623, 00802526557019, 00802526565304, 00802526579929, 00802526583803, 00802526602931, 00802526605468, 00802526606304, 00802526612411, 00802526615627, 00802526442827, 00802526444807, 00802526469374, 00802526477683, 00802526482267, 00802526497650, 00802526517198, 00802526540400, 00802526555169, 00802526564826, 00802526582325, 00802526585104, 00802526586316, 00802526586316, 00802526603013, 00802526606328, 00802526612435, 00802526615429, 00802526474057, 00802526477522, 00802526479649, 00802526482274, 00802526486470, 00802526497667, 00802526517211, 00802526540509, 00802526555206, 00802526564833, 00802526582318, 00802526585111, 00802526586408, 00802526603006, 00802526605420, 00802526606335, 00802526612404, 00802526615504, 00802526480669, 00802526605451, 00802526496653, 00802526526824, 00802526527630, 00802526527630, 00802526564840, 00802526581038, 00802526582035, 00802526584602, 00802526582035, 00802526605451, 00802526606403, and 00802526612459.
Products Sold
All serial numbers. GTIN numbers in the U.S.: 00802526434723, 00802526456961, 00802526467653, 00802526468582, 00802526473449, 00802526474859, 00802526475788, 00802526477676, 00802526478239, 00802526479663, 00802526480638, 00802526484599, 00802526486906, 00802526494406, 00802526497605, 00802526516009, 00802526523212, 00802526535406, 00802526554209, 00802526562600, 00802526564703, 00802526575303, 00802526579707, 00802526582004, 00802526602900, 00802526604584, 00802526606366, 00802526606403, and 00802526611322. GTIN numbers OUS: 00802526435430, 00802526468582, 00802526479663, 00802526480638, 00802526486906, 00802526478246, 00802526479670, 00802526484605, 00802526486913, 00802526496608, 00802526496615, 00802526506703, 00802526515903, 00802526517112, 00802526526602, 00802526527609, 00802526554803, 00802526561900, 00802526564802, 00802526574801, 00802526579905, 00802526582011, 00802526602917, 00802526605406, 00802526606342, 00802526611308, 00802526615603, 00802526437458, 00802526441974, 00802526444814, 00802526467288, 00802526469343, 00802526475450, 00802526475757, 00802526477669, 00802526478253, 00802526479687, 00802526484612, 00802526486920, 00802526496622, 00802526496639, 00802526515910, 00802526517136, 00802526526800, 00802526527616, 00802526554810, 00802526564819, 00802526574818, 00802526581021, 00802526582028, 00802526605437, 00802526606311, 00802526612428, 00802526615634, 00802526454301, 00802526467295, 00802526469350, 00802526475467, 00802526475764, 00802526477676, 00802526484803, 00802526486081, 00802526486937, 00802526497629, 00802526515927, 00802526532832, 00802526557002, 00802526565427, 00802526582301, 00802526587405, 00802526602924, 00802526606359, 00802526612442, 00802526445262, 00802526454950, 00802526474170, 00802526475474, 00802526475771, 00802526480652, 00802526486944, 00802526497643, 00802526517174, 00802526526817, 00802526527623, 00802526557019, 00802526565304, 00802526579929, 00802526583803, 00802526602931, 00802526605468, 00802526606304, 00802526612411, 00802526615627, 00802526442827, 00802526444807, 00802526469374, 00802526477683, 00802526482267, 00802526497650, 00802526517198, 00802526540400, 00802526555169, 00802526564826, 00802526582325, 00802526585104, 00802526586316, 00802526586316, 00802526603013, 00802526606328, 00802526612435, 00802526615429, 00802526474057, 00802526477522, 00802526479649, 00802526482274, 00802526486470, 00802526497667, 00802526517211, 00802526540509, 00802526555206, 00802526564833, 00802526582318, 00802526585111, 00802526586408, 00802526603006, 00802526605420, 00802526606335, 00802526612404, 00802526615504, 00802526480669, 00802526605451, 00802526496653, 00802526526824, 00802526527630, 00802526527630, 00802526564840, 00802526581038, 00802526582035, 00802526584602, 00802526582035, 00802526605451, 00802526606403, and 00802526612459.
Boston Scientific Corporation is recalling Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 28 due to The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recalling firm issued letters flagged "Important Medical Device Information" dated 30 November 2023 to Dear Physician or Healthcare Professional (HCP) via Federal Express or courier with signed receipt in the U.S. on 11/30/2023. The letter provides a description of unanticipated behavior and clinical impact and provides a recommendation to keep the letter with all Model 3120 programmers at their center or distribute the letter to all HCPs who perform pacemaker checks using a Model 3120 ZOOM programmer. When using the Model 2892 software application on the programmer, if a date includes a year in the 1990s, the HCPs may (1) determine a precise date by interrogating an ALTRUA, INSIGNIA, or NEXUS pacemaker with a Model 3300 LATITUDE programmer; or (2) determine an approximate date (within a two-day range) using the table in Appendix A of the letter. (Appendix A is a table listing the incorrectly displayed date in the 1990s and what the approximate date should be if the date was displayed correctly.) The addressee is informed that Boston Scientific does not recommend prophylactic replacement of pacemakers due to incorrect dates. An acknowledgement form is enclosed for completion and return.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026