Abbott Proclaim 5 Elite implantable pulse generator service life may be shorter than labeled
The Abbott Proclaim 5 Elite implantable pulse generator may reach end of service earlier than product labeling indicates. Approximately 38,530 units are affected 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: This is an FDA Class II medical device recall with a documented functional defect affecting device longevity. Although no injuries or hospitalizations are reported in the source text, the shortened service life poses a genuine risk of therapy interruption requiring emergency replacement intervention.
Plain-English summary
The Abbott Proclaim 5 Elite Implantable Pulse Generator (Reference number 3660) is being recalled because the device may reach its end of service sooner than indicated in the product labeling. Specifically, the duration between when the device reaches the elective replacement indicator (ERI) threshold and when it actually stops functioning may be shorter than documented in the labeling.
This affects approximately 38,530 units distributed worldwide, including throughout the United States and in multiple countries including Canada, Mexico, Australia, Japan, the United Kingdom, and many others. All serial numbers of the affected product are included in this recall.
The implantable pulse generator is a device used to deliver electrical stimulation for therapeutic purposes. If the device reaches end of service sooner than expected, patients may experience interruption of therapy and require emergency replacement surgery sooner than anticipated. This is a Class II medical device recall issued by the FDA.
Patients who have received this implantable pulse generator should contact their healthcare provider or the manufacturer for guidance on whether their specific device is affected and what follow-up monitoring or device replacement may be necessary.
The recalled product
- Product
- Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
- Manufacturer
- Abbott Medical
- Hazard
- premature-failure
- mis-labeling
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)
- 05415067020192/ All Serial Numbers
Distribution
Distributed nationwide across the United States.
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