Abbott Medical Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Brand
Abbott Medical
Lot Codes / Batch Numbers
All Serial numbers/UDI:05415067030016/05415067020246
Products Sold
All Serial numbers/UDI:05415067030016/05415067020246
Abbott Medical is recalling Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only due to Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product l. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026