GUARDIAN™ 6010 (UDI 05415067030283)Recalls & reported problems
St. Jude Medical, Inc. · Cranial Burr Hole Cover Sys. · Class 2 · Implant
Quick summary
This St. Jude Medical Guardian burr hole cover is an implant that closes a skull opening used for brain implant leads. Its 150 adverse event reports are all listed as injuries, with no deaths, and most describe infections, open wounds, and erosion at the cover or lead site, often requiring surgery to remove the hardware. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 151
- Deaths reported
- 0
- Injuries reported
- 151
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 05415067030283), received between Sep 20, 2019 and Sep 30, 2026 — classified as 151 injuries.
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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem145
- Insufficient Device Problem Information4
- No Apparent Adverse Event3
- Material Fragmentation2
Patient problems
- Unspecified Infection59
- Post Operative Wound Infection42
- Erosion21
- Wound Dehiscence15
- Skin Erosion9
- Fluid Discharge7
- Purulent Discharge6
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 25 most recent of 151 reports, 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 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION AT THE BURR HOLE CAP SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE BURR HOLE CAP AND RIGHT LEAD WERE EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 24377104 ↗InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A SUSPECTED INFECTION AT THE RIGHT INCISION SITE. THE CULTURES CONFIRMED THE INCISION DIDN'T HEAL PROPERLY. THE PATIENT WAS THEN GIVEN ANTIBIOTICS, AND THE RIGHT BURR HOLE CAP WAS EXPLANTED AND REPLACED. THE INVESTIGATION DID NOT DETERMINE WHICH BURR HOLE CAP ATTRIBUTED TO THIS ISSUE.
Patient problems: Fluid Discharge
MAUDE report 24164790 ↗InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS NOT HEALING AND THE LEAD HAD ERODED AT THE BURR HOLE SITE. IN TURN, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE DBS SYSTEM EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Erosion
MAUDE report 23961143 ↗InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT'S SYSTEM WAS INFECTED AT THE BURR HOLE SITES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE INFECTION WAS TREATED WITH POWDER ANTIBIOTICS.
Patient problems: Post Operative Wound Infection
MAUDE report 23889400 ↗InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT'S SYSTEM WAS INFECTED AT THE BURR HOLE SITES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE INFECTION WAS TREATED WITH POWDER ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 23889395 ↗InjuryDec 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S EXTENSIONS, LEADS AND BURR HOLE COVERS WERE EXPLANTED AND REPLACED FOR AN UNKNOWN REASON. THE INVESTIGATION DID NOT DETERMINE WHICH PRODUCTS ATTRIBUTED TO THIS ISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 23843774 ↗InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED AN OPEN-WOUND AT THE RIGHT BURR HOLE CAP SITE AND EXPERIENCED A SEIZURE WHILE CLEANING THE WOUND. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE RIGHT BURR HOLE CAP WAS REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY. IT IS UNKNOWN WHICH BURR HOLE CAP WAS REPLACED.
Patient problems: Convulsion/Seizure; Fall; Wound Dehiscence
MAUDE report 23372129 ↗InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN EROSION AT THE RIGHT-SIDE BURR HOLE COVER. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHERE THEY CLEANED THE AREA, PERFORMED A SKIN GRAFT, AND CLOSED. THE PATIENT WAS ADMITTED FOR 4-5 DAYS AND RECEIVED ANTIBIOTICS. NO SIGNS OF INFECTION WERE REPORTED.
Patient problems: Erosion
MAUDE report 23334021 ↗InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE LEFT BURR HOLE CAP AND WAS HOSPITALIZED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 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 22791216 ↗InjuryJul 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR LEAD, EXTENSION AND BURR HOLE CAP EXPLANTED FOR AN UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 22659833 ↗
Other COVER, BURR HOLE devices
- GUARDIAN™ 6010St. Jude Medical, Inc. · COVER, BURR HOLE1 death25 reports
- "1.5MM" SYSTEM 95-1505Biomet Microfixation, Inc · COVER, BURR HOLE23 reports
- "1.5MM" SYSTEM 91-6105Biomet Microfixation, Inc · COVER, BURR HOLE20 reports
- CRANIOFIX® ABSORBABLE FF016Aesculap AG · COVER, BURR HOLE8 reports
- "1.5MM" SYSTEM 91-6106Biomet Microfixation, Inc · COVER, BURR HOLE7 reports
- 1.5MM SYSTEM 91-6105X-50Biomet Microfixation, Inc · COVER, BURR HOLE6 reports
- TMS SYSTEM 25-2007Biomet Microfixation, Inc · COVER, BURR HOLE3 reports
- 1.5MM SYSTEM 01-7114Biomet Microfixation, Inc · COVER, BURR HOLE2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.