TIDIShield 5429Recalls & reported problems
Tidi Products, LLC · TIDIShield C-arm Equipment Covers Green Kit Sterile Fits OEC 9600/9800, Siemens ARCADIS Avantic, Sieme 20 per Case · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00618125140107), received between Nov 14, 2025 and Mar 6, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2026Contamination
THERE WAS A HAIR IN THE STERILE DRAPE OF THE 5429 C-ARM DRAPE KIT. UNFORTUNATELY, IT WAS ONE OF THE LAST ITEMS TO BE PLACED ON THE STERILE FIELD WHICH CAUSED US TO WASTE EVERYTHING WE HAD PREVIOUSLY OPENED FOR THE CASE DUE TO CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24538190 ↗MalfunctionNov 14, 2025Break; Break
THE CLIPS FREQUENTLY POP OFF AND THERE IS A RISK TO IT LANDING IN THE STERILE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555078 ↗
Other Drape, Surgical, Exempt devices
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- Medline DYNJP2498Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls1 report
- Medline DYNJP8005UGMedline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP3103Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP8304AMedline Industries, Inc. · Drape, surgical, exempt3 recalls0 reports
- Medline DYNJP9103Medline Industries, Inc. · Drape, surgical, exempt2 recalls7 reports
- Medline DYNJP8201Medline Industries, Inc. · Drape, surgical, exempt2 recalls6 reports
- Medline DYNJP6006Medline Industries, Inc. · Drape, surgical, exempt2 recalls4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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