FLASH Ostial System OTW OTW6012BARecalls & reported problems
Verge Medical, Inc. · FLASH Ostial System, Dual Balloon Angioplasty Catheter, 0.035" OVER-THE-WIRE, 6.0mm x 12mm · Class 2
Data updated Oct 16, 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 M917OTW6012BA0), received between Aug 18, 2018 and Aug 18, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE FDA FORWARDED OSTIAL CORPORATION AN MDR FROM A USER FACILITY INDICATING THAT ONE OF THE BALLOONS FOR A FLASH OSTIAL SYSTEM OTW DEVICE MAY HAVE BEEN DAMAGED DURING USE AND "NEVER HELD ANY PRESSURE". THERE WERE NO PATIENT INJURIES REPORTED IN ASSOCIATION WITH THIS EVENT. AT THIS TIME, THE USER FACILITY HAS BEEN UNABLE TO PROVIDE OSTIAL CORPORATION WITH ANY ADDITIONAL FEEDBACK REGARDING THE REPORTED EVENT AND HAS NOT INDICATED IF THE DEVICE USED IN THIS CASE IS AVAILABLE FOR EVALUATION. ADDITIONAL DETAILS FROM THE USER FACILITY MDR REPORT ARE PROVIDED BELOW: INTENDED PROCEDURE: FIVE VESSEL FENESTRATED/BRANCHED- EVAR WITH PMEG ZFEN- P- 2- 26- 124-R INCLUDING DISTAL BIFURCATE ZFEN- D- 12 - 28- 91-C AND STENTED FENESTRATIONS TO THE CELIAC, SMA, RIGHT RENAL ARTERY, LEFT MAIN RENAL ARTERY, AND STENTED BRANCH TO THE LEFT LOWER POLE RENAL ARTERY. PERCUTANEOUS ACCESS OF BILATERAL COMMON FEMORAL ARTERIES WITH PRECLOSURE OF 20 FR SHEATH ON THE RIGHT AND 14 FR SHEATH ON THE LEFT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7795812 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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