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

FDA device recall Z-0673-2024 · posted 2024-01-05 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LWS

Quantity affected

14,328 ZOOM programmers

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, Aust

Date initiated

2023-11-30

Date posted

2024-01-05

Location

Saint Paul, MN