Agency classClass IIOur severity:High FDA (Devices)·Z-2358-2024·Announced 2024-07-24

Abbott Proclaim XR 5 Implantable Pulse Generator Battery Labeling Error

Abbott Proclaim XR 5 implantable pulse generators may reach end of service sooner than product labeling indicates, affecting approximately 83,511 units worldwide. Patients should contact their healthcare provider for guidance on device monitoring and replacement planning.

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 a Class II medical device recall with no reported injuries or hospitalizations. It involves a risk-of-harm medical device where an implantable pulse generator may reach end of service sooner than labeled, potentially disrupting expected patient therapy. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

Abbott Medical is recalling the Proclaim XR 5 Implantable Pulse Generator (REF 3660), affecting approximately 83,511 units distributed worldwide, including throughout the United States and multiple countries.

The duration between when the device reaches its elective replacement indicator (ERI) threshold and when it reaches end of service may be shorter than indicated in the product labeling. This means the implantable pulse generator battery may deplete sooner than patients and physicians expect based on the labeled timeline.

The recall affects patients worldwide who have received this device across all US states, US territories, and multiple international locations.

Patients with this device should contact their healthcare provider or Abbott Medical for guidance on their specific situation and any necessary device monitoring and replacement planning.

The recalled product

Product: Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Manufacturer: Abbott Medical
Category: Medical Device — Implantable Pulse Generator
Hazard: battery-failure
labeling-discrepancy
Affected units: 83,511

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)

UDI: 05415067031419/ All Serial Numbers

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Part of a larger recall action

This product is one of 12 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 12 products in this recall →

Same manufacturer · Abbott Medical

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Same hazard · battery failure