PentaRecalls & reported problems across all models
St. Jude Medical, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5,504
- Deaths reported
- 12
- Injuries reported
- 5,470
- Recalls
- 0
We found 2 models of Penta by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 5,504 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 30, 2026 — classified as 12 deaths, 5,470 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (1,207 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 Penta problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,655
- Therapeutic or Diagnostic Output Failure1,207
- High impedance1,154
- Migration787
- Fracture284
- Impedance Problem179
- Inappropriate/Inadequate Shock/Stimulation116
- Insufficient Device Problem Information100
Patient problems
- Inadequate Pain Relief3,443
- No Clinical Signs, Symptoms or Conditions460
- Failure of Implant296
- Post Operative Wound Infection238
- Undesired Nerve Stimulation169
- Unspecified Infection169
- Hematoma149
- No Consequences Or Impact To Patient134
Penta models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Penta™ 3228STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11 deaths5,201 reports
- Penta™ 3228STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death303 reports
Recent Penta adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Post Operative Wound Infection
MAUDE report 50952812 ↗InjurySep 29, 2026Therapeutic or Diagnostic Output Failure
Patient problems: Inadequate Pain Relief
MAUDE report 50940433 ↗InjurySep 29, 2026Therapeutic or Diagnostic Output Failure
Patient problems: Inadequate Pain Relief
MAUDE report 50939794 ↗InjurySep 29, 2026High impedance
It was reported that the patient experienced ineffective therapy due to high impedances on the lead. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50936400 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported patient was experiencing lead erosion through the skin. The patient¿s lead was revised on 15SEP2026. Therapy was restored post-op.
Patient problems: Erosion
MAUDE report 50935672 ↗InjurySep 28, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924669 ↗InjurySep 28, 2026Therapeutic or Diagnostic Output Failure
Patient problems: Inadequate Pain Relief
MAUDE report 50923276 ↗InjurySep 28, 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 system was explanted to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50923221 ↗InjurySep 28, 2026High impedance
It was reported that the patient was unable to place their system into MRI mode and experienced ineffective therapy. Diagnostics revealed high impedance on the lead. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50916747 ↗InjurySep 28, 2026High impedance
It was reported patient experienced ineffective stimulation and inability to enable MRI mode. Diagnostics showed high impedances on the lead. As a result, the lead was explanted and replaced to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50913984 ↗InjurySep 25, 2026Impedance Problem
Patient problems: Inadequate Pain Relief
MAUDE report 50905883 ↗InjurySep 25, 2026Impedance Problem
Patient problems: Inadequate Pain Relief
MAUDE report 50903266 ↗InjurySep 25, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50902461 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following implanting procedure, patient experienced epidural hematoma. As result, surgical intervention was undertaken wherein the entire system was explanted to address the issue.
Patient problems: Hematoma; Muscle Weakness/Atrophy; Urinary Incontinence
MAUDE report 50893013 ↗InjurySep 24, 2026Migration
Patient problems: Inadequate Pain Relief
MAUDE report 50892465 ↗
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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