ViperCath XC 035-XC-200-0Recalls & reported problems
Cardiovascular Systems, Inc. · 200 cm, 0.035" guidewire compatible, support catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10852528005688), received between Dec 20, 2024 and Dec 20, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2024Break; Air/Gas in Device; Break; Air/Gas in Device
IT WAS REPORTED THAT DURING REMOVAL OF THE VIPERCATH XC EXCHANGE CATHETER DURING TREATMENT VIA RADIAL ACCESS, AIR WAS OBSERVED SUSPECTING A HOLE IN THE VIPERCATH. THE ISSUE WAS OBSERVED WHEN THE PHYSICIAN DREW THE SYRINGE BACK TO CONFIRM IF THE BLOOD WAS GETTING BACK AND IT WAS FILLED WITH AIR. THE CONTRAST WAS NOT INJECTED THROUGH THE CATHETER BECAUSE OF THE AIR COMING BACK. THERE WAS NO AIR PRESENT INSIDE THE PATIENT. THE VIPERCATH WAS REMOVED FROM PATIENT AND A NEW VIPERCATH WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY ADVERSE EFFECTS TO THE PATIENT. NO DAMAGE WAS OBSERVED TO THE VIPERCATH UPON REMOVAL. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20991003 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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