Abbott Infinity 5 Pulse Generator May Have Inaccurate Battery-Life Labels
Abbott Infinity 5 implantable pulse generators have inaccurate end-of-service dates in labeling, which may result in loss of therapy. Approximately 5,900 units are affected and distributed worldwide.
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 implantable medical devices with inaccurate labeling that could lead to loss of therapeutic function. No illnesses or deaths have been reported, making this a risk-of-harm situation without documented injury, which falls within the 'High' severity category.
Plain-English summary
Abbott Medical is recalling the Abbott Infinity 5 Implantable Pulse Generator (model REF: 6660). The recall affects approximately 5,900 units.
The product labeling may contain inaccurate information regarding the device's replacement indicator and end-of-service date. Specifically, these indicators may be shorter than what is stated in the labeling. This inaccuracy has the potential to result in loss of therapy.
The affected devices were distributed worldwide, including throughout the United States and multiple international locations. Patients with these devices should contact their healthcare provider or Abbott Medical for guidance.
The recalled product
- Product
- Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
- Manufacturer
- Abbott Medical
- Hazard
- mis-labeling
- device-failure
- loss-of-therapy
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:05415067030016/05415067020246
Distribution
Distributed nationwide across the United States.
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