GUARDIANRecalls & reported problems across all models
St. Jude Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 177
- Deaths reported
- 1
- Injuries reported
- 174
- Recalls
- 0
We found 3 models of GUARDIAN by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 177 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2017 and Sep 30, 2026 — classified as 1 death, 174 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 GUARDIAN problems
Device problems
- Adverse Event Without Identified Device or Use Problem168
- Insufficient Device Problem Information4
- No Apparent Adverse Event3
- Material Fragmentation2
- Mechanical Problem2
- Unstable2
- Improper or Incorrect Procedure or Method1
Patient problems
- Unspecified Infection66
- Post Operative Wound Infection48
- Erosion22
- Wound Dehiscence15
- Skin Erosion9
- Fluid Discharge7
- No Clinical Signs, Symptoms or Conditions7
- Purulent Discharge6
GUARDIAN models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GUARDIAN™ 6010COVER, BURR HOLE151 reports
- GUARDIAN™ 6010COVER, BURR HOLE1 death25 reports
- GUARDIAN™ 6015COVER, BURR HOLE1 report
Recent GUARDIAN 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: Unspecified Infection
MAUDE report 50952991 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported patient had infection at the burr hole site. Investigation was unable to identify which burr hole cap attributed to the issue. Surgical intervention was undertaken wherein the left lead and burr hole were removed. Patient was prescribed anti-biotics to address the issue.
Patient problems: Unspecified Infection
MAUDE report 50828436 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erosion
MAUDE report 50643293 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
it was reported that patient experienced reduced wound healing in the right lead and burr hole cap site. As result, surgical intervention was undertaken wherein the lead and burr hole cap site was cleaned and sutured to address the issue.
Patient problems: Impaired Healing
MAUDE report 50072070 ↗InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT¿S BURR HOLE COVER WAS EXPOSED. THE SITE APPEARED INFECTED. THE PATIENT REPORTS A HARD FALL SEVERAL MONTHS PRIOR. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE LEAD AND BURR HOLE COVER WERE EXPLANTED.
Patient problems: Skin Erosion; Unspecified Infection
MAUDE report 25752189 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT EXPERIENCED EROSION AT THE BURR HOLE CAP. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026 WHEREIN THE AREA WAS CLEANED OUT AND THE BURR HOLE CAP WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Erosion
MAUDE report 25394495 ↗InjuryMay 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ON THE LEFT SIDE OF THE LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS TO ADDRESS THE ISSUE. THE INFECTION HAS RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 25196102 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT EXPERIENCED AN OPEN WOUND AT THE BURR HOLE COVER. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Erosion
MAUDE report 25071523 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2026 TO ADDRESS THE ISSUE.
Patient problems: Post Operative Wound Infection
MAUDE report 24867123 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE LEAD SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2026 TO ADDRESS THE ISSUE.
Patient problems: Post Operative Wound Infection
MAUDE report 24867122 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE RIGHT LEAD AND BURR HOLE CAP SITE AND WAS HOSPITALIZED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE RIGHT LEAD AND BURR HOLE CAP WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS TO ADDRESS THE ISSUE.
Patient problems: Post Operative Wound Infection; Wound Dehiscence
MAUDE report 24519984 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT'S SYSTEM WAS INFECTED AT THE BURR HOLE AND IPG POCKET SITES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM EXPLANTED. PATIENT WAS PRESCRIBED ANTIBIOTICS TO ADDRESS THE INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 24393747 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT HAD A SCALP INFECTION. PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Post Operative Wound Infection
MAUDE report 24393744 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT HAD A SCALP INFECTION. PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Post Operative Wound Infection
MAUDE report 24393743 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT'S SYSTEM WAS INFECTED AT THE BURR HOLE AND IPG POCKET SITES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM EXPLANTED. PATIENT WAS PRESCRIBED ANTIBIOTICS TO ADDRESS THE INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 24381554 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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