# FDA recall Z-2364-2024

> **Abbott Medical** · Class II · device recall initiated 2024-05-16.

## Product

Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only

## Reason for recall

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.

## Distribution

Worldwide - US Nationwide distribution including in the states of ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, GUAM, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY, LOUISIANA,MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO, NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, PUERTO RICO, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VERMONT, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN, WYOMING and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy	, Japan, Korea, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Reunion Russian Federation, Saudi Ar

## Key facts

- **Recall number:** Z-2364-2024
- **Recalling firm:** Abbott Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-16
- **Report date:** 2024-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plano, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2364-2024

## Citation

> AI Analytics. FDA recall Z-2364-2024. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-2364-2024. Source: US FDA. Licensed CC0.

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