Chaperon Guiding Catheter GC595M2VTRecalls & reported problems
Microvention, Inc. · Guides · 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 00810170012372), received between Aug 25, 2021 and Aug 25, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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.
Most reported problems
Device problems
- Material Rupture1
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.
MalfunctionAug 25, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING TREATMENT, A CHAPERON GUIDING CATHETER RUPTURED AT THE PROXIMAL END, OUTSIDE OF THE PATIENT. 200ML OF BLOOD FLOWED BACK OUT OF THE RUPTURED SEGMENT OF THE CATHETER. NO PORTION OF THE RUPTURED SEGMENT ENTERED THE PATIENT'S BODY. THE DEVICE WAS EXCHANGED FOR ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12367578 ↗
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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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