Agency classClass IIOur severity:High FDA (Devices)·Z-2430-2024·Announced 2024-07-31

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.

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 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
Category: Medical Device — Implantable Pulse Generator
Hazard: device-malfunction
loss-of-therapy
premature-end-of-service
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: 05415067020253

Distribution

Distributed nationwide across the United States.

The notice also names 36 states specifically:

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.

See all 4 products in this recall →

Same manufacturer · Abbott Medical

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