FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
- Recall number
- Z-0319-2021
- Recalling firm
- Boston Scientific Corporation
- Product
- Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
- Status
- Terminated
- Initiated
- 2020-09-22
- Posted
- not on file
- Terminated
- 2024-09-04
- Reason
- There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.
- Root cause
- Software design
- Action
- Boston Scientific sales representatives will hand-deliver a removal letter to all customer consignees with one of the eight affected Model 3300 LATITUDE programmer. BSC sales representatives will maintain control of these devices. In order to continue to provide the benefits that this software support application provides for those patients implanted with an ALTRUA/INSIGNIA I pacemaker, BSC sales representatives will continue to use Model 3300 LATITUDE programmers installed with the Model 3892 v1.04 ALTRUA / INSIGNIA I / NEXUS I Software Support Application in the field. The risks associated with this unintended behavior can be avoided when specific remedial actions are adhered to. These remedial actions will be adhered to until a software correction is approved and installed on these programmers. BSC will confirm via email from sales representatives that 100% of the removal letters were delivered. BSC will post the removal letter on the BSC website within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/productadvisories.html.
- Quantity
- 8 devices
- Distribution
- Distributed in US - AR, FL, IL, and TX
- Lot, serial or model codes
- Model 3892 v1.04 is installed on Model 3300 LATITUDE Programming Systems with the following serial numbers: 009494 012689 010356 008206 008124 007983 004813 010751
- 510(k) numbers
- not on file
- PMA numbers
- ["P910077S178"]
- Product code
- LWS
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28