Abbott Proclaim Plus 7 implantable pulse generator recalled for shortened service life
Abbott recalls 1,086 Proclaim Plus 7 implantable pulse generators due to labeling inaccuracy. Devices may reach end of service sooner than labeled, potentially reducing the time patients have to plan for 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 an FDA Class II recall with no reported injuries, illnesses, or deaths. The hazard is a potential discrepancy between labeled and actual device service life, constituting a risk-of-harm to patients dependent on the device. Since no actual harm has been reported and the hazard is theoretical, this meets the criteria for High severity per the rubric.
Plain-English summary
Abbott Medical is recalling 1,086 units of the Proclaim Plus 7 implantable pulse generator, Model 3672. The affected devices have been distributed worldwide, including throughout the United States.
The recalled devices have a labeling discrepancy concerning their service life. The duration between when the device reaches its elective replacement indicator threshold and when it actually reaches end of service may be shorter than indicated in the product labeling. This means patients may have less time than expected to prepare for device replacement.
Patients with these devices should contact their healthcare provider to discuss their individual situation and determine whether additional monitoring or earlier replacement planning is necessary.
The recalled product
- Product
- Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, 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)
- 05415067046406/ All Serial Numbers
Distribution
Distributed nationwide across the United States.
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