Abbott Proclaim Plus 5 Pulse Generator May Have Shorter Service Life Than Labeled
Abbott is recalling 38 Proclaim Plus 5 Implantable Pulse Generators because they may reach end of service sooner than product labeling indicates, potentially affecting pain management therapy for affected patients.
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 an FDA Class II recall of an implanted medical device where the service life may be shorter than labeled, presenting a risk of device failure before patients expect replacement. Although no illnesses or injuries have been reported in the source, this constitutes a risk-of-harm product per the rubric, warranting a High severity rating.
Plain-English summary
Abbott Medical is recalling 38 Proclaim Plus 5 Implantable Pulse Generators (reference number 3671) that have been distributed worldwide, including throughout the United States. The recall addresses a potential discrepancy between the product labeling and the device's actual performance.
The issue is that the duration between when the device reaches its elective replacement indicator threshold and its actual end of service may be shorter than indicated in the product labeling. This means patients relying on this device for pain management may have less time to arrange for device replacement than they expect based on the labeling information.
Patients who have received a Proclaim Plus 5 Implantable Pulse Generator should contact their healthcare provider to confirm whether their device is affected by this recall and to discuss any necessary actions, such as monitoring or replacement options.
The recalled product
- Product
- Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
- Manufacturer
- Abbott Medical
- Hazard
- shortened-service-life
- labeling-inaccuracy
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 (1)
- 05415067046390/ All Serial Numbers
Distribution
Distributed nationwide across the United States.
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