High FDA (Devices)·Z-1671-2022·Announced 2022-09-07

Boston Scientific ZOOM LATITUDE Programmer Software Anomaly Recall

Boston Scientific ZOOM LATITUDE programmer software may have anomalies when communicating with certain Boston Scientific defibrillators, potentially affecting device programming and communication functions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving potential software anomalies in a cardiac device programmer that controls communication with life-critical implantable defibrillators. Although no adverse events or injuries have been reported, the risk-of-harm nature of the product justifies a High severity rating per the rubric criterion: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Boston Scientific Corporation issued a recall of the Model 2868 Application software loaded on the 3120 ZOOM LATITUDE programmer, a device used to communicate with Boston Scientific implantable pulse generators and transvenous defibrillators. The software application controls all communication functions between the programmer and these implanted devices.

The recall was initiated due to the potential for unanticipated software anomalies that may occur when the programmer communicates with certain Boston Scientific transvenous defibrillators. These anomalies could affect the ability to properly program and communicate with the implanted device.

Approximately 17,172 units are affected globally. The recall identifies specific UPN and serial number combinations impacted, which are detailed in the FDA recall notice.

Patients with Boston Scientific transvenous defibrillators should contact their healthcare provider or Boston Scientific to determine whether their programmer is affected. Healthcare providers should verify whether their equipment is included in the recall and follow Boston Scientific's recommended actions.

The recalled product

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.
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Cardiac Device Programmer
Hazard: software-anomaly
communication-failure
Affected units: 17,172

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UPN: 00802526434723
Serial Numbers: 051026
051075
051091
051121
051146
051156
051171
051182
051207
051232
051236
051239
051270
051320
051335
051358
051367
051370
051374

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Boston Scientific Corporation

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