Abbott Medical Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, 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 Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Brand
Abbott Medical
Lot Codes / Batch Numbers
UDI: 05415067031419/ All Serial Numbers
Products Sold
UDI: 05415067031419/ All Serial Numbers
Abbott Medical is recalling Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only due to The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than ind. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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