Abbott Infinity 7 Pulse Generator May Have Shorter-Than-Labeled Service Date
The Abbott Infinity 7 implantable pulse generator's replacement indicator and end-of-service date may be shorter than the product labeling states, potentially leading to loss of therapy 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 an FDA Class II recall involving an implantable cardiac device with risk-of-harm from potential loss of therapy. No illnesses or injuries have been reported in the source text, and the hazard is described with cautious language ('potential that,' 'may be'), placing it in the High category for risk-of-harm products without reported injury.
Plain-English summary
Abbott Medical is recalling the Abbott Infinity 7 Implantable Pulse Generator (REF 6662) due to a potential issue with its replacement indicator and end-of-service date. These indicators may be shorter than stated in the product labeling, potentially resulting in loss of therapy.
A total of 20,790 units have been distributed worldwide across all US states and to multiple countries. The affected serial numbers are 05415067030023 and 05415067020260.
Patients who have received this device are affected and should contact their healthcare provider immediately to discuss this recall and determine if their device is affected. Healthcare providers are being notified to monitor this issue.
The recalled product
- Product
- Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
- Manufacturer
- Abbott Medical
- Hazard
- loss-of-therapy
- device-failure
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)
- All Serial numbers/UDI: 05415067030023 and 05415067020260
Distribution
Distributed nationwide across the United States.
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