Sapphire II Pro 230-153-5UURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955942334), received between Jun 26, 2024 and Jul 10, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF SEVERELY CALCIFIED LESIONS IN THE CIRCUMFLEX (CFX) ARTERY VIA FEMORAL APPROACH. THE PROXIMAL OSTIAL LESION WAS 70% STENOSED AND THE MID DISTAL LESION WAS 95% STENOSED. THE VESSEL DIAMETER WAS 3.5MM. SEVERAL LOW-SPEED TREATMENTS WERE PERFORMED. IMAGING WAS CHECKED POST ATHERECTOMY AND THE VESSEL LOOKED FINE. A 3.0 X 15MM SAPPHIRE II PRO SZ BALLOON WAS ADVANCED TO THE LESION AND INFLATED THREE TIMES. THE FIRST INFLATION WAS 12 ATMOSPHERES (ATM) FOR FIFTEEN SECONDS. THE SECOND INFLATION WAS 8 ATM FOR TEN SECONDS. THE THIRD INFLATION WAS 8 ATM FOR TWENTY SECONDS. FOLLOWING ANGIOPLASTY, IMAGING WAS CHECKED, AND A PERFORATION WAS OBSERVED. COVERED-STENT PLACEMENT WAS PERFORMED TO TREAT THE PERFORATION. A SECOND STENT WAS PLACED TO COVER THE LESION. THE PATIENT WAS STABLE. IN THE OPINION OF THE PHYSICIAN, THE EVENT WAS DUE TO PATIENT'S ANATOMY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024 AFTER A PLANNED OVERNIGHT STAY AT THE HOSPITAL UNRELATED TO THE REPORTED PERFORATION.

  Patient problems: Perforation of Vessels

  MAUDE report 19711734 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF SEVERELY CALCIFIED LESIONS IN THE CIRCUMFLEX (CFX) ARTERY VIA FEMORAL APPROACH. THE PROXIMAL OSTIAL LESION WAS 70% STENOSED AND THE MID DISTAL LESION WAS 95% STENOSED. THE VESSEL DIAMETER WAS 3.5MM. SEVERAL LOW-SPEED TREATMENTS WERE PERFORMED. IMAGING WAS CHECKED POST ATHERECTOMY AND THE VESSEL LOOKED FINE. A 3.0 X 15MM SAPPHIRE II PRO SZ BALLOON WAS ADVANCED TO THE LESION AND INFLATED THREE TIMES. THE FIRST INFLATION WAS 12 ATMOSPHERES (ATM) FOR FIFTEEN SECONDS. THE SECOND INFLATION WAS 8 ATM FOR TEN SECONDS. THE THIRD INFLATION WAS 8 ATM FOR TWENTY SECONDS. FOLLOWING ANGIOPLASTY, IMAGING WAS CHECKED, AND A PERFORATION WAS OBSERVED. COVERED-STENT PLACEMENT WAS PERFORMED TO TREAT THE PERFORATION. A SECOND STENT WAS PLACED TO COVER THE LESION. THE PATIENT WAS STABLE. IN THE OPINION OF THE PHYSICIAN, THE EVENT WAS DUE TO PATIENT'S ANATOMY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024. BACKGROUND: LESION INFORMATION: CIRCUMFLEX ARTERY (PROXIMAL OSTIAL LESION 70% AND MID-DISTAL LESION 95% STENOSED, SEVERELY CALCIFIED). THE VESSEL DIAMETER WAS 3.5MM. PATIENT COMPLICATION: VESSEL PERFORATION. THE BALL

  Patient problems: Perforation of Vessels

  MAUDE report 19612025 ↗