ProclaimRecalls & reported problems across all models

We found 12 models of Proclaim by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 35,038 adverse event reports in the FDA's MAUDE database, received between Aug 15, 2016 and Sep 30, 2026 — classified as 59 deaths, 30,950 injuries, 4,028 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (8,185 reports).

17 FDA recall records name at least one of these models by its device identifier, 17 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Proclaim recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 16, 2024Open, Classified

   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.

   Z-2369-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

2. May 16, 2024Open, Classified

   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.

   Z-2368-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

3. May 16, 2024Open, Classified

   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.

   Z-2367-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

4. May 16, 2024Open, Classified

   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.

   Z-2366-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

5. May 16, 2024Open, Classified

   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.

   Z-2365-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

6. May 16, 2024Open, Classified

   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.

   Z-2364-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

7. May 16, 2024Open, Classified

   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.

   Z-2363-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

8. May 16, 2024Open, Classified

   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.

   Z-2362-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

9. May 16, 2024Open, Classified

   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.

   Z-2361-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

10. May 16, 2024Open, Classified

    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.

    Z-2360-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

11. May 16, 2024Open, Classified

    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.

    Z-2359-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

12. May 16, 2024Open, Classified

    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.

    Z-2358-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

13. Jul 18, 2023Open, Classified

    Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

    Z-2509-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

14. Jul 18, 2023Open, Classified

    Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

    Z-2508-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

15. Jul 18, 2023Open, Classified

    Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

    Z-2507-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

16. Jul 18, 2023Open, Classified

    Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

    Z-2506-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

17. Jul 18, 2023Open, Classified

    Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

    Z-2505-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Proclaim problems

Proclaim models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Proclaim™ 3660

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  2 recalls25 deaths13,336 reports
• Proclaim™ 5 Elite

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 recall10 deaths9,661 reports
• Proclaim™ 7 Elite

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 recall12 deaths7,299 reports
• Proclaim™ DRG

  Dorsal root ganglion stimulator for pain relief
  2 recalls8 deaths2,177 reports
• Proclaim™ 3670

  Stimulator, spinal-cord, totally implanted for pain relief
  2 recalls2 deaths1,253 reports
• Proclaim™ 3662

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  2 recalls1 death867 reports
• Proclaim™ 5

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 recall223 reports
• Proclaim™ 3672

  Stimulator, spinal-cord, totally implanted for pain relief
  2 recalls121 reports
• Proclaim™ 7

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 recall1 death69 reports
• Proclaim™ 3665

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 recall20 reports
• Proclaim™ 3667

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 recall8 reports
• Proclaim™ 3671

  Stimulator, spinal-cord, totally implanted for pain relief
  1 recall4 reports

Recent Proclaim adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Wireless Communication Problem

  It was reported that following an unrelated surgical procedure wherein the device was not placed into surgery mode, the IPG became unable to communicate with external devices. Troubleshooting has been unable to resolve the issue. As a result, surgical intervention may be undertaken.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50951908 ↗
• InjurySep 30, 2026Wireless Communication Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50951787 ↗
• MalfunctionSep 30, 2026Wireless Communication Problem

  It was reported the patient system was unable to disable MRI mode following an MRI. An Abbott representative met with the patient and was able to successfully disable the patient¿s IPG from MRI Mode using an Orion Exit Tool (OET). Once the IPG was taken out of MRI Mode, the patient controller and/or clinician programmer were able to bond with the IPG, and restored therapy.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50951052 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50949377 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient experienced pain at the IPG site and ineffective therapy. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50949229 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50949122 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50948753 ↗
• InjurySep 30, 2026Temperature Problem

  Patient problems: Burning Sensation

  MAUDE report 50948643 ↗
• InjurySep 30, 2026Migration

  It was reported that the patients IPG has tilted causing discomfort at the pocket site. Additionally, the patient states there is warmth at the pocket site. Surgical intervention may be taken at a later date to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50948638 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following weight loss, the patient experienced discomfort at the IPG site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was replaced, and the pocket site was modified to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50946088 ↗
• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 50939805 ↗
• InjurySep 29, 2026Wireless Communication Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50938912 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported that the patient's system was explanted. The reason for explant and date of explant is unknown.

  Patient problems: Insufficient Information

  MAUDE report 50938842 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported that the patient¿s system was explanted 4-5 years ago. Reason for explant and date of explant is unknown.

  Patient problems: Insufficient Information

  MAUDE report 50938821 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported patient underwent surgical intervention wherein the system was explanted due to an unknown issue.

  Patient problems: Insufficient Information

  MAUDE report 50938718 ↗

Other St. Jude Medical, Inc. products

• Tendril15 models · 49,498 reports
• Octrode10 models · 36,740 reports
• Durata28 models · 19,805 reports
• Assurity MRI2 models · 17,838 reports · 1 recall
• Gallant8 models · 12,885 reports · 5 recalls
• Quartet10 models · 11,001 reports
• MitraClip19 models · 9,056 reports · 2 recalls
• Fortify Assura8 models · 8,292 reports