Sapphire II Pro 210-103-5UURecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 06934955942037), received between Mar 17, 2024 and May 5, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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.

• InjuryMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE INTENDED PROCEDURES WERE LEFT HEART CATHETERIZATION, BYPASS GRAFT ANGIOGRAPHY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) OF THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA). THE 1.0 X10 MM SAPPHIRE BALLOON CAME OFF OF THE DELIVERY CATHETER AND WAS PERMANENTLY LODGED IN RPDA.

  Patient problems: Foreign Body In Patient

  MAUDE report 21960481 ↗
• MalfunctionApr 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE INTENDED PROCEDURES WERE LEFT HEART CATHETERIZATION, BYPASS GRAFT ANGIOGRAPHY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) OF THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA). THE 1.0 X10 MM SAPPHIRE BALLOON CAME OFF OF THE DELIVERY CATHETER AND WAS PERMANENTLY LODGED IN RPDA. BACKGROUND: 1. OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: CABG [CORONARY ARTERY BYPASS GRAFT] X2004, PCI [PERCUTANEOUS CORONARY INTERVENTION] WITH STENT, HYPERLIPIDEMIA. 2. PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: CORONARY HEART DISEASE; DIABETES; HYPERTENSION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21916491 ↗
• MalfunctionApr 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE INTENDED PROCEDURES WERE LEFT HEART CATHETERIZATION, BYPASS GRAFT ANGIOGRAPHY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) OF THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA). THE 1.0 X10 MM SAPPHIRE BALLOON CAME OFF OF THE DELIVERY CATHETER AND WAS PERMANENTLY LODGED IN RPDA. BACKGROUND: 1. OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: CABG [CORONARY ARTERY BYPASS GRAFT] X 2004, PCI [PERCUTANEOUS CORONARY INTERVENTION] WITH STENT, HYPERLIPIDEMIA. 2. PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: CORONARY HEART DISEASE; DIABETES; HYPERTENSION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21915851 ↗
• InjuryMar 18, 2024Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  DURING THE PROCEDURE, THE SAPPHIRE BALLOON FRACTURED, AND THE TIP BECAME STUCK IN THE SIDE CELL OF THE LEFT ANTERIOR DESCENDING (LAD) STENT INTO THE DIAGONAL. MULTIPLE DIFFERENT WIRES AND A NON-CSI/ABBOTT CATHETER WERE USED TO DISLODGE THE FRACTURED FRAGMENT. AS THE FRACTURED FRAGMENT WAS BEING RETRIEVED, IT FELL OFF THE WIRE IN THE AORTA AND BECAME LOST. IN THE PHYSICIAN'S OPINION, THE EMBOLIZATION LIKELY OCCURRED IN THE PATIENT'S LEGS. TO COMPLETE THE PROCEDURE, A DRUG-ELUTING STENT WAS PLACED IN THE LEFT MAIN ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque; Embolism/Embolus; Foreign Body In Patient

  MAUDE report 18921030 ↗
• InjuryMar 17, 2024Material Separation; Material Separation

  DURING THE PROCEDURE, THE SAPPHIRE BALLOON FRACTURED, AND THE TIP BECAME STUCK IN THE SIDE CELL OF THE LEFT ANTERIOR DESCENDING (LAD) STENT INTO THE DIAGONAL. MULTIPLE DIFFERENT WIRES AND A NON-CSI AND ABBOTT CATHETER WERE USED TO DISLODGE THE FRACTURED FRAGMENT. AS THE FRACTURED FRAGMENT WAS BEING RETRIEVED, IT FELL OFF THE WIRE IN THE AORTA AND BECAME LOST. IN THE PHYSICIAN'S OPINION, EMBOLIZATION LIKELY OCCURRED IN THE PATIENT'S LEGS. TO COMPLETE THE PROCEDURE, A DRUG-ELUTING STENT WAS PLACED IN THE LEFT MAIN ARTERY. PATIENT STATUS IS SATISFACTORY. THE DEVICE HISTORY RECORD FOR THIS LOT: (4203462309) HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO OTHER SIMILAR COMPLAINTS WERE RECEIVED FROM THE SAME LOT OF PRODUCTS UP TO NOW. ORBUSNEICH MEDICAL MANUFACTURING PROCESSES INCLUDE EXTENSIVE TESTING AND INSPECTIONS TO ENSURE EACH PRODUCT MEETS ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO RELEASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18919210 ↗