ExclaimRecalls & reported problems across all models
St. Jude Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 284
- Deaths reported
- 1
- Injuries reported
- 278
- Recalls
- 0
We found 3 models of Exclaim by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 284 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Sep 30, 2026 — classified as 1 death, 278 injuries, 5 malfunctions.
The most frequently reported specific device problem is “High impedance” (93 reports).
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
Reports received per month, all models
Most reported Exclaim problems
Device problems
- High impedance93
- Adverse Event Without Identified Device or Use Problem57
- Migration49
- Therapeutic or Diagnostic Output Failure49
- Fracture25
- Impedance Problem11
- Failure to Deliver Energy6
- Inappropriate/Inadequate Shock/Stimulation5
Patient problems
- Inadequate Pain Relief229
- Failure of Implant15
- No Clinical Signs, Symptoms or Conditions10
- Post Operative Wound Infection9
- Undesired Nerve Stimulation5
- Unspecified Infection5
- Pain4
- No Consequences Or Impact To Patient3
Exclaim models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Exclaim™ 3225STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death246 reports
- Exclaim™ 3225STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF32 reports
- Exclaim™ 3224STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 reports
Recent Exclaim adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Therapeutic or Diagnostic Output Failure
It was reported that the patient reported that the lead placed as trial to perm lead required an extended hospital stay during the trail and now does not have effective therapy as the lead has migrated and system is not working at this time. Patient reports no communication, but it is not known if the charging was maintained. As a result, surgical intervention may be taken at a later date.
Patient problems: Inadequate Pain Relief
MAUDE report 50948561 ↗InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation
It was reported that the patient experienced shocking sensations. Evaluation of the system indicated high impedances on multiple contacts. As a result, surgical intervention may be undertaken to address the issue. It is unknown which lead is related to this issue.
Patient problems: Burning Sensation
MAUDE report 50901218 ↗InjurySep 18, 2026Therapeutic or Diagnostic Output Failure
It was reported that the patient experienced ineffective therapy. Reprogramming has been unable to resolve the issue. As a result, surgical intervention was undertaken wherein system was explanted to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50813435 ↗InjuryAug 5, 2026Therapeutic or Diagnostic Output Failure
It was reported that the patient experienced ineffective therapy, shocking sensations, numbness in the extremities, vasovagal syncope, cardiac event and atrial fibrillation. As a result, surgical intervention was undertaken on an unknown date wherein the entire system was explanted to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50147495 ↗InjuryAug 3, 2026Therapeutic or Diagnostic Output Failure
It was reported that the patient experienced ineffective therapy. As a result, surgical intervention was undertaken on an unknown date wherein the entire system was explanted to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50122451 ↗InjuryJun 16, 2026High impedance
IT WAS REPORTED THAT THE PATIENT'S CERVICAL LEAD EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN IN (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. AFTER EXPLANT, IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT LEAD INCISION SITE.
Patient problems: Inadequate Pain Relief
MAUDE report 25527839 ↗InjuryJun 3, 2026High impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, PATIENTS LEAD HAS HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25384249 ↗InjuryApr 29, 2026High impedance
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS SHOWED HIGH IMPEDANCES. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25033478 ↗InjuryApr 16, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCE INEFFECTIVE THERAPY. PATIENT¿S LEAD HAD MIGRATED. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026 WHEREIN THE LEAD WAS REPOSITIONED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST OP.
Patient problems: Inadequate Pain Relief
MAUDE report 24905592 ↗InjuryApr 12, 2026High impedance
IT WAS REPORTED THAT THE PATIENT REPORTED INEFFECTIVE STIMULATION. DIAGNOSTIC REPORTS INDICATED THE LEAD HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24853014 ↗InjuryApr 3, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24779205 ↗InjuryMar 4, 2026High impedance; No Apparent Adverse Event
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, PATIENTS LEAD HAS HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 24514267 ↗InjuryFeb 25, 2026Malposition of Device
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO MALPOSITION OF THE DEVICE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24445287 ↗InjuryFeb 19, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24393509 ↗InjuryFeb 19, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24393503 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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