Skip to content

ZOOM LATITUDE recallZ-0673-2024 · Boston Scientific Corporation · initiated Nov 30, 2023

Class II Open, Classified All recalls posted in January 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0673-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Nov 30, 2023
Posted by the FDA
Jan 5, 2024
Recalling firm
Boston Scientific Corporation
Quantity
14,328 ZOOM programmers
Product code
LWS
FDA submissions
P910077
Distribution
Distribution was nationwide, including Guam, Puerto Rico, and the U.S. Virgin Islands. There was also government/military distribution. Foreign distribution was made to Andorra, Argentina, Aruba, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, British Virgin Islands, Bulgaria, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Faroe Islands, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Madagascar, Malaysia, Malta, Mauritius, Mexico, Morocco, Namibia, Netherlands, Netherlands Antilles, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Yemen, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan R.O.C., Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, Uruguay, Venezuela, Vietnam, and Zimbabwe.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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.

Devices named in this recall

9 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

25 devices cleared under P910077 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page