Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 25, 2017
Proclaim DRG Implantable Pulse Generator Model 3664
Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed e…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
St. Jude Medical, Inc. recalled Proclaim DRG Implantable Pulse Generator Model 3664 - a moderate-severity action.
Proclaim DRG Implantable Pulse Generator Model 3664 was recalled by St. Jude Medical, Inc. in October 25, 2017. Reason: Analysis of the difference between the actual device longevity and the battery indicator status provided by t…. Check the official notice for the remedy. Verify recall #Z-0024-2018 with the FDA Devices before acting.
The recall
St. Jude Medical, Inc. issued this moderate-severity FDA Devices recall-Analysis of the difference between the actual device longevity and the battery indicator status provided by t….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- October 25, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0024-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0024-2018) was formally reported on October 25, 2017, with the manufacturer initiating the action on September 12, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. St. Jude Medical, Inc. is listed as the recalling firm, operating out of Plano, TX. Federal records list the affected scope as 1744 devices.
The documented reason for this recall is: Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimati… Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time). Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1744 devices
Related Recalls
6
0 from same agency
Product description
Proclaim DRG Implantable Pulse Generator Model 3664
Reason for recall
Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0024-2018 |
| Date reported | October 25, 2017 |
| Date initiated | September 12, 2017 |
| Recalling firm | St. Jude Medical, Inc. |
| Firm location | Plano, TX |
| Affected scope | 1744 devices |
| Distribution | Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time) |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0024-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Proclaim DRG Implantable Pulse Generator Model 3664. Recalled by St. Jude Medical, Inc.. Units affected: 1744 devices.
Why was this product recalled? ▼
Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2017. Severity: Moderate. Recall number: Z-0024-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time).
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0024-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 25, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.