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 DRG Implantable Pulse Generator Recalled by St. Jude Medical, Inc. Due to The firm received complaints of error messages that...

Date: March 9, 2018
Company: St. Jude Medical, Inc.
Status: Terminated
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 St. Jude Medical, Inc. directly.

Affected Products

Proclaim DRG Implantable Pulse Generator, Model Number 3664

Quantity: 17 units

Why Was This Recalled?

The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for the patients.

Where Was This Sold?

US

About St. Jude Medical, Inc.

St. Jude Medical, Inc. has 13 total recalls tracked by RecallDetector.

Related Recalls

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