Class II Recall

Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Applic

Summary

The FDA issued a Class II for Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) ins by Boston Scientific Corporation. Reason: The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, .

Details

Source

Device Recall

External ID

Z-0673-2024

Action Date

2024-01-17

Status

Ongoing

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.

Lot/Code Info: 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.

Quantity Affected: 14,328 ZOOM programmers

Reason for Recall

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.

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-11-30

Company

Boston Scientific Corporation

Saint Paul, MN

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 158 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Boston Scientific Corporation have FDA actions?

Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0673-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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