Recall archive / FDA device enforcement

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific ... — FDA record Z-1671-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 7, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
Reason: There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Classification: Class II
Recalling firm: Boston Scientific Corporation
Quantity: 17,172 units in total
Agency-reported status: Ongoing
Source record identifier: Z-1671-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
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Label field

Details supplied by the agency

Lot, code or applicability

UPN: 00802526434723, Serial Numbers: 051026, 051075, 051091, 051121, 051146, 051156, 051171, 051182, 051207, 051232, 051236, 051239, 051270, 051320, 051335, 051358, 051367, 051370, 051374, 051413, 051418, 051425, 051432, 051435, 051456, 051459, 051473, 051478, 051486, 051487, 051495, 051501, 051511, 051533, 051535, 051549, 051552, 051558, 051561, 051580, 051584, 051592, 051593, 051612, 051623, 051626, 051632, 051640, 051655, 051696, 051727, 051745, 051763, 051769, 051770, 051784, 051808, 051818, 051846, 051850, 051863, 051906, 051924, 051931, 051989, 051997, 052018, 052022, 052030, 052034, 052088, 052131, 052145, 052202, 052320, 052460, 054970, 054981, 054993, 054996, 055007, 055016, 055020, 055023, 055037, 055041, 055048, 055059, 055065, 055066, 055069, 055070, 055079, 055086, 055089, 055098, 055113, 055117, 055122, 055132, 055142, 055148, 055154, 055157, 055172, 055174, 055191, 055193, 055205, 055211, 055213, 055214, 055219, 055227, 055246, 055248, 055253, 055256, 055270, 055277, 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Report date: Sep 7, 2022
Recall initiation date: Jul 7, 2022
Center classification date: Sep 1, 2022

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