Z-2367-2024Class II

Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only

Name: Z-2367-2024 Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
Creator: Abbott Medical
Published: 2024-05-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-05-16 / Open, Classified / root cause: supplier

FDA source

Abbott Medical began a recall of Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only on 2024-05-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2367-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-16
Posted: 2024-07-16
Recalling firm: Abbott Medical
Product: Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
Product code: PMP Dorsal Root Ganglion Stimulator For Pain Relief
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.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: On June 6, 2024, Abbott issued a Urgent Medical Device Correction notification to affected consignees. Abbott asked consignees to take the following actions: 1. This issue will continue to affect your patients for the foreseeable future. Abbott is working on an update to align the product labeling with actual device performance. 2. When an ERI notification appears, see the following considerations to make a determination with your patients on timing of IPG replacement within the customer notification. 3. See the customer notification for recommended strategies for preventing lapse in therapy. 4. Please return a completed Acknowledgement Form and maintain a record of this notice along with a copy of the completed Acknowledgement Form. 5. For questions about this issue or reported complaints, please contact your Abbott representative, or Abbott Technical Support at 1-800-727-7846. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 21,843 units
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 Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.
Product codes and lots: 05415067020215/ All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2367-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2358-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16
Z-2359-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16
Z-2360-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16
Z-2361-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16
Z-2362-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16
Z-2363-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16
Z-2364-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16
Z-2365-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16
Z-2366-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16
Z-2367-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16
Z-2368-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16
Z-2369-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-16

Product code PMP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)