The Recall Desk
HighFDA (Devices)·Z-2363-2024·Announced 2024-07-24

Abbott Proclaim 7 Pulse Generator Battery Life Shorter Than Labeled

Abbott is recalling approximately 457 Proclaim 7 Implantable Pulse Generators because the battery may reach end of service sooner than indicated in labeling. Patients may require unexpected device replacement.

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 a Class II medical device recall with no reported injuries, illnesses, or deaths in the source text. However, it involves a risk-of-harm product (implanted pulse generator) where shortened battery life could necessitate unexpected surgical replacement. Per the rubric, risk-of-harm products where injury has not yet been reported are scored at 3 (High).

Plain-English summary

Abbott Medical is recalling approximately 457 units of the Proclaim 7 Implantable Pulse Generator (REF 3667, all serial numbers) distributed worldwide, including across all U.S. states, territories, and multiple international countries.

The recalled devices may reach their end of service before the duration indicated in the product labeling. This means the battery life of the implanted device may be shorter than patients and physicians expect, potentially requiring unexpected surgical device replacement.

Patients with implanted Proclaim 7 devices should contact their healthcare provider to discuss their device and determine whether replacement is necessary. Healthcare providers can identify affected devices by checking all serial numbers against the recall notice.

The recalled product

Product
Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
Manufacturer
Abbott Medical
Category
Medical Device — Implantable Pulse Generator
Hazard
Affected units
457

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)

  • 05415067023254/ 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 →

Related recalls

Same manufacturer · Abbott Medical

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