Z-0319-2021Class II

Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support...

Name: Z-0319-2021 Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support...
Creator: Boston Scientific Corporation
Published: 2020-09-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-09-22 / Terminated / root cause: software

FDA source

Boston Scientific Corporation began a recall of Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application on 2020-09-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0319-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-22
Posted: 2020-10-31
Terminated: 2024-09-04
Recalling firm: Boston Scientific Corporation
Product: Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: 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 tag: software
FDA 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 in commerce: 8 devices
Distribution: Distributed in US - AR, FL, IL, and TX
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0319-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0319-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-10-31

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)