Abbott Proclaim 5 Pulse Generator May Have Shorter Than Labeled Battery Duration
Abbott Proclaim 5 Implantable Pulse Generators may have a shorter battery lifespan than labeled, potentially affecting replacement timing for 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 a Class II recall of a life-sustaining medical device involving a labeling discrepancy regarding battery duration. While no illnesses or injuries have been reported, the potential for unexpected device failure due to inaccurate battery-life labeling represents meaningful risk to patients, consistent with high-risk products where injury has not yet been reported.
Plain-English summary
Abbott Medical is recalling the Proclaim 5 Implantable Pulse Generator (REF 3665) because the duration between when the device reaches the "elective replacement indicator" threshold and when it actually ends its service life may be shorter than stated in the product labeling. This means patients and physicians may not have as much time as expected before the device needs replacement.
Approximately 1,119 units of this device have been distributed worldwide, including across all U.S. states and territories, as well as in multiple countries internationally. All serial numbers of this product are affected.
Patients with this implantable pulse generator should contact their healthcare provider or Abbott Medical to discuss their individual situation and determine whether their specific device needs evaluation or replacement. Healthcare providers should refer to the FDA recall notice for complete instructions and guidance.
The recalled product
- Product
- Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
- Manufacturer
- Abbott Medical
- Hazard
- mis-labeling
- device-failure-risk
- battery-depletion
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)
- 05415067023247/ All Serial Numbers
Distribution
Distributed nationwide across the United States.
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