FLASH MINI Ostial System OCB4008BARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M917OCB4008BA0), received between Jan 20, 2017 and Mar 27, 2025 — classified as 2 deaths, 3 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Use of Device Problem; Use of Device Problem

  THE EVENT DESCRIPTION WAS PROVIDED TO OSTIAL VIA EMAIL BY THEIR SALES REPRESENTATIVE, ALONG WITH USER FACILITY REPORT MDR # (B)(4) FROM THE FDA. THE DESCRIPTION STATED THAT DURING A COMPLEX INTERVENTION, ATTEMPTS WERE MADE TO ADVANCE AN OSTIAL FLASH BALLOON INTO THE CORONARY ARTERY FOR ANGIOPLASTY. THE BALLOON WOULD NOT ADVANCE ALL THE WAY THROUGH THE GUIDE AND HAD TO BE REMOVED. THE FLASH DEVICE WAS PROMPTLY REMOVED FROM SERVICE, AND THERE WAS NO HARM TO THE PATIENT. THE USER FACILITY REPORT MDR # (B)(4) INDICATED A DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710525 ↗
• MalfunctionMar 2, 2024Device Handling Problem; Device Handling Problem

  THE USER FACILITY REPORTED DIFFICULTY PREPARING THE FLASH DEVICE. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18823349 ↗
• DeathAug 10, 2017Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Device Handling Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Device Handling Problem

  THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED FROM THE HOSPITAL: FOLLOWING TREATMENT OF A RAMUS INTERMEDIUS ARTERY, THE PHYSICIAN ATTEMPTED TO USE THE FLASH MINI OSTIAL SYSTEM IN THE PATIENT'S RCA. WHEN INFLATING THE PROXIMAL BALLOON, BOTH ENDS OF THE BALLOON WERE NOTED AS EXPANDING (DOG BONE), RESULTING IN A VESSEL DISSECTION. THE PATIENT SUBSEQUENTLY CODED AND EXPIRED.

  Patient problems: Death; Vascular Dissection

  MAUDE report 6787283 ↗
• MalfunctionFeb 10, 2017Deflation Problem; Occlusion Within Device; Compatibility Problem; Torn Material; Deflation Problem; Occlusion Within Device; Compatibility Problem; Torn Material

  IT WAS REPORTED THAT ONE OF THE BALLOONS ON A 4.0X8MM FLASH MINI DEVICE COULD NOT BE DEFLATED AND THAT WHEN ATTEMPTING TO WITHDRAW THE STILL INFLATED BALLOON INTO THE GUIDE CATHETER THAT THE CATHETER SHAFT BROKE. THE USER WAS ABLE TO SUCCESSFULLY REMOVE BOTH PIECES OF THE FLASH MINI DEVICE BY RETRACTING THE DEVICE AND GUIDE CATHETER AS A SINGLE UNIT. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6324593 ↗
• DeathJan 20, 2017Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Device Handling Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Device Handling Problem

  A 4.0X12MM XIENCE STENT WAS DEPLOYED AT THE OSTIUM OF THE PATIENT'S RCA. THE PHYSICIAN ATTEMPTED TO POST DILATE THE STENT USING A 4.0X8MM FLASH MINI OSTIAL SYSTEM DEVICE. THE DISTAL BALLOON INFLATED AS EXPECTED; HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE PROXIMAL BALLOON, IT WAS NOTED THAT THE SHAPE ON THE CINE DID NOT LOOK CORRECT. THE BALLOONS WERE DEFLATED AND IT WAS FOUND THAT VESSEL HAD TORN/RUPTURED AND THE PATIENT BECAME UNRESPONSIVE AND WENT INTO RESPIRATORY DISTRESS. ATTEMPTS TO REVIVE THE PATIENT WERE UNSUCCESSFUL AND THE PATIENT PASSED AWAY.

  Patient problems: Death; Perforation of Vessels

  MAUDE report 6268842 ↗