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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 5,900
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
Part of a larger recall action
This product is one of 4 recalled by Abbott Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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