Abbott Proclaim 7 Implantable Pulse Generator May Reach End-of-Service Sooner Than Labeled
Abbott is recalling 569 units of the Proclaim 7 implantable pulse generator because the device may reach end-of-service sooner than indicated in labeling. All affected units were distributed worldwide.
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: FDA Class II classification with an inherently high-risk product (implantable cardiac device), but no reported injuries, deaths, or illnesses. The hazard is a timing discrepancy affecting device replacement planning, not immediate patient harm. This meets the High severity criterion as a risk-of-harm product without reported harm.
Plain-English summary
Abbott Medical is recalling 569 units of the Proclaim 7 Implantable Pulse Generator (Model REF 3663) due to a discrepancy between the device's labeled and actual operational duration.
The device may reach end-of-service sooner than indicated in the product labeling. Specifically, the duration from when the elective replacement indicator threshold is reached until the device reaches end-of-service may be shorter than what the labeling specifies. The elective replacement indicator is the threshold at which the device alerts physicians that replacement should be planned.
The recall affects 569 units distributed worldwide, including throughout the United States and internationally to multiple countries. Patients with an affected device should contact their healthcare provider to discuss their specific device status and any necessary follow-up.
The recalled product
- Product
- Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
- Manufacturer
- Abbott Medical
- Category
- Medical Device — Pulse Generator
- Hazard
- service-duration-discrepancy
- labeling-error
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)
- 05415067020239/ All Serial Numbers
Distribution
Distributed nationwide across the United States.
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