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

Recall Insight

This FDA Devices action (record #Z-2358-2024) was formally reported on July 24, 2024, with the manufacturer initiating the action on May 16, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Abbott Medical is listed as the recalling firm, operating out of Plano, TX. Federal records indicate 83,511 units units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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, I…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.