Abbott Infinity 5 Pulse Generator May Fail Prematurely
Abbott is recalling 5,900 Infinity 5 implantable pulse generators because the replacement indicator and end-of-service date may be shorter than labeled, potentially causing premature device failure. Patients should contact their doctor about device status.
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 hospitalizations, injuries, or illnesses. It involves a risk-of-harm product (implantable pulse generator) where no injury has been reported, fitting the criteria for a High severity rating per the recall rubric.
Plain-English summary
Abbott Medical is recalling 5,900 Infinity 5 implantable pulse generators (REF: 6661) distributed worldwide because the replacement indicator and end-of-service date programmed in these devices may be shorter than the timeframe indicated in the product labeling.
This means affected devices may indicate a need for replacement sooner than expected, or may cease providing therapy before the labeled end-of-service date, potentially resulting in loss of therapeutic function for patients depending on the device.
The recall affects all units with serial numbers/UDI 05415067020253, distributed in the United States and internationally.
Patients with this device should contact their healthcare provider immediately to verify whether their device is included in this recall and discuss appropriate device management.
The recalled product
- Product
- Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
- Manufacturer
- Abbott Medical
- Hazard
- device-malfunction
- loss-of-therapy
- premature-end-of-service
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: 05415067020253
Distribution
Distributed nationwide across the United States.
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