Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

FDA device recall Z-2369-2024 · posted 2024-07-16 · Open, Classified

Recall details

Recalling firm

Abbott Medical

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.

Action taken

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.

Root cause

Vendor change control

Status

Open, Classified

Product code

LGW

Quantity affected

38,530 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,

Date initiated

2024-05-16

Date posted

2024-07-16

Location

Plano, TX