FLASH MINI Ostial System OCB4508BARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M917OCB4508BA0), received between Oct 19, 2017 and Mar 27, 2025 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 3 most recent of 3 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 MALFUNCTION OF DEVICES. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710485 ↗
• InjuryJan 14, 2023Material Rupture; Use of Device Problem; Improper or Incorrect Procedure or Method; Material Rupture; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE EVENT DESCRIPTION WAS PROVIDED TO OSTIAL IN AN EMAIL RECEIVED FROM FDA FOR THE USER FACILITY REPORT MDR#: 1001760000-2022-8008. THE EVENT DESCRIPTION IN THE MDR INDICATED THE PROXIMAL BALLOON BURST DUE TO THE USE OF A STANDARD MANIFOLD SYRINGE FOR INJECTION (10 ML) INSTEAD OF THE SUPPLIED SYRINGE CALLED FOR IN THE IFU (1 ML) WHICH MAY HAVE INADVERTENTLY CAUSED THE BALLOON TO BURST. ADDITIONALLY, AN "AIR EMBOLISM" WAS OBSERVED BY THE PHYSICIAN TRAVELING DOWN THE CORONARY ARTERY. PER THE MDR REPORT, THIS DID NOT CAUSE ANY PERMANENT ADVERSE OUTCOMES AND REQUIRED ONLY INITIAL MONITORING TO PREVENT HARM.

  Patient problems: Air Embolism

  MAUDE report 16169484 ↗
• DeathOct 19, 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 AND LOCAL SALES REPRESENTATIVES: THE PATIENT WAS ADMITTED TO THE ER AND THEN TAKEN TO THE CATH LAB FOR TREATMENT OF STEMI. THE PHYSICIAN DEPLOYED A 3.0MM DIAMETER STENT IN A CALCIFIED CHRONIC TOTAL OCCLUSION OF THE RCA AND THEN REQUESTED A FLASH DEVICE FOR USE IN POST-DILATION OF THE STENT. THE CATH LAB DID NOT HAVE ANY 3.0MM DIAMETER FLASH DEVICES AT THE TIME, ONLY A 4.5MM DIAMETER FLASH DEVICE WAS AVAILABLE. THE PHYSICIAN DECIDED TO USE THE HIGHER DIAMETER 4.5MM DIAMETER FLASH DEVICE TO POST DILATE THE 3.0MM STENT. FOLLOWING INFLATION OF THE FLASH DEVICE, A DISSECTION OCCURRED AND THE VESSEL SHUT DOWN. CPR WAS IMMEDIATELY STARTED; HOWEVER, THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death; Vascular Dissection

  MAUDE report 6962212 ↗