Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only

FDA device recall Z-2429-2024 · posted 2024-07-25 · Open, Classified

Recall details

Recalling firm

Abbott Medical

Reason for recall

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

Action taken

On June 6, 2024, Abbott, issued a "Urgent Medical Device Correction" notification to affected consignees via mail. 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. For information on when an ERI notification appears and how to make a determination with your patients on timing of IPG replacement, see the customer communication. 3. For recommended strategies for preventing lapse in therapy, see the customer communication. 4. Please inform your patients about this medical device correction letter. 5. Please return a completed Acknowledgement Form and maintain a record of this notice along with a copy of the completed Acknowledgement Form. 6. For questions about this issue or reported complaints, please contact your Abbott representative, or Abbott Technical Support at 1-800-727-7846. 7. 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

Error in labeling

Status

Open, Classified

Product code

MHY

Quantity affected

5,900 units

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, WA

Date initiated

2024-05-22

Date posted

2024-07-25

Location

Plano, TX