Abbott Proclaim 7 Pulse Generator Battery Life Shorter Than Labeled
Abbott is recalling approximately 457 Proclaim 7 Implantable Pulse Generators because the battery may reach end of service sooner than indicated in labeling. Patients may require unexpected device replacement.
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 medical device recall with no reported injuries, illnesses, or deaths in the source text. However, it involves a risk-of-harm product (implanted pulse generator) where shortened battery life could necessitate unexpected surgical replacement. Per the rubric, risk-of-harm products where injury has not yet been reported are scored at 3 (High).
Plain-English summary
Abbott Medical is recalling approximately 457 units of the Proclaim 7 Implantable Pulse Generator (REF 3667, all serial numbers) distributed worldwide, including across all U.S. states, territories, and multiple international countries.
The recalled devices may reach their end of service before the duration indicated in the product labeling. This means the battery life of the implanted device may be shorter than patients and physicians expect, potentially requiring unexpected surgical device replacement.
Patients with implanted Proclaim 7 devices should contact their healthcare provider to discuss their device and determine whether replacement is necessary. Healthcare providers can identify affected devices by checking all serial numbers against the recall notice.
The recalled product
- Product
- Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
- Manufacturer
- Abbott Medical
- Hazard
- battery-life-mismatch
- device-malfunction-risk
- labeling-accuracy
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)
- 05415067023254/ All Serial Numbers
Distribution
Distributed nationwide across the United States.
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