Abbott Infinity 7 Implantable Pulse Generators Recalled for Potentially Shortened Service Life
Abbott is recalling 1198 Infinity 7 Implantable Pulse Generators due to potentially incorrect service life indicators and end-of-service dates in product labeling, which could result in loss of therapy.
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 of an implantable cardiac device where the hazard—potential loss of therapy due to incorrect end-of-service dating—is theoretical, with no reported illnesses or injuries. This meets the criteria for High severity per the rubric.
Plain-English summary
Abbott Medical is recalling 1198 Abbott Infinity 7 Implantable Pulse Generators (REF: 6663, SterileEO, Rx Only) distributed worldwide.
The device's replacement indicator and end-of-service date information may be shorter than indicated in the product labeling. This could result in loss of therapy if patients do not receive timely device replacement.
The affected devices were distributed worldwide, including throughout the United States and to numerous other countries. The affected units are identified by UDI: 05415067020277.
Healthcare providers and patients should contact Abbott Medical for guidance on managing these devices and addressing this issue.
The recalled product
- Product
- Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
- Manufacturer
- Abbott Medical
- Hazard
- loss-of-therapy
- mis-labeling
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: 05415067020277
Distribution
Distributed nationwide across the United States.
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