Boston Scientific ZOOM LATITUDE Programmer Software Anomaly Recall
Boston Scientific is recalling ZOOM LATITUDE programmers due to potential software anomalies that could affect communication with implantable defibrillators. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall with potential software anomalies affecting a critical medical device used to communicate with implantable defibrillators. No illnesses or injuries have been reported; the hazard is theoretical rather than confirmed, placing this in the High category as a risk-of-harm product where injury has not yet occurred.
Plain-English summary
The Programmer/Recorder/Monitor (PRM) component of Boston Scientific's ZOOM LATITUDE Programming System is being recalled. This device is designed to communicate with Boston Scientific implantable pulse generators and control all communication functions for these life-critical devices.
The recall addresses potential for unanticipated software anomalies in the Model 2868 Application when the programmer communicates with certain Boston Scientific transvenous defibrillators. These software anomalies could affect the programmer's ability to properly communicate with the implantable devices, though no illnesses or injuries have been reported to date.
Approximately 17,172 units of the affected programmer have been distributed worldwide. The recalled devices are identified by specific Universal Product Numbers and serial numbers provided in the FDA recall notice.
Patients implanted with Boston Scientific defibrillators and healthcare providers using affected programmers should contact Boston Scientific immediately for guidance. Do not use an affected programmer until receiving direction from Boston Scientific or your healthcare provider.
The recalled product
- Product
- The Programmer/Recorder/Monitor (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
- 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.
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