Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Proclaim 7 Elite Implantable Pulse Generator Recalled by Abbott Medical Due to The duration between the implantable pulse generator reaching...

Date: May 16, 2024
Company: Abbott Medical
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Medical directly.

Affected Products

Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only

Quantity: 30,673 units

Why Was This Recalled?

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Medical

Abbott Medical has 42 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report