Sapphire II Pro 220-203-5UURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955942198), received between Mar 26, 2026 and Mar 26, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Material Separation

  IT WAS REPORTED THAT A SAPPHIRE II BALLOON CAME APART AT DISTAL AREA OF BALLOON. FIRST ADDITIONAL INFORMATION WAS RECEIVED ON 03/04/2026: 1. PROVIDE A DETAILED SUMMARY OF EVENT FROM BEGINNING TO END, INCLUDING TROUBLESHOOTING AND RESOLUTION. - WAITING ON EMAIL FROM HOSPITAL. 2. ANATOMICAL INFORMATION? (VESSEL / LOCATION / TORTUOSITY / CALCIFICATION / STENOSIS % / ETC.) - UNKNOWN. 3. PLEASE PROVIDE PATIENT DEMOGRAPHICS (GENDER, AGE, WEIGHT, RACE, ETHNICITY) AND COMORBIDITIES. IF UNAVAILABLE, PLEASE PROVIDE REASON WHY (E.G. HOSPITAL PRIVACY POLICY) - I THOUGHT I CHOSE THE HOSPITAL PRIVATE POLICY. 4. DID THE BALLOON BECOME FULLY DETACHED OR WAS IT DAMAGED INTACT? - IT LOOKS LIKE IT'S DETACHED. 5. HOW WAS THE BALLOON FRAGMENT(S) REMOVED FROM THE PATIENT? - HE REMAINS WITH A WALL STENT COVERING. 6. IF FRAGMENT(S) REMAIN IN VIVO - DOES THE PHYSICIAN HAVE ANY CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUTCOMES? - THE HOSPITAL SHOULD BE SENDING INFORMATION. 7. WHAT IS THE STATUS OF THE PATIENT? - UNKNOWN. SECOND ADDITIONAL INFORMATION WAS RECEIVED ON 3/13/2026: 1. PROVIDE A DETAILED SUMMARY OF EVENT FROM BEGINNING TO END, INCLUDING TROUBLESHOOTING AND RESOLUTION. - IT SEEMS THEY WERE USING TH

  Patient problems: Foreign Body In Patient

  MAUDE report 24696400 ↗
• InjuryMar 26, 2026Material Separation

  IT WAS REPORTED THAT A SAPPHIRE II BALLOON CAME APART AT DISTAL AREA OF BALLOON. FIRST ADDITIONAL INFORMATION WAS RECEIVED ON 3/4/2026: 1. PROVIDE A DETAILED SUMMARY OF EVENT FROM BEGINNING TO END, INCLUDING TROUBLESHOOTING AND RESOLUTION. WAITING ON EMAIL FROM HOSPITAL. 2. ANATOMICAL INFORMATION? (VESSEL / LOCATION / TORTUOSITY / CALCIFICATION / STENOSIS % / ETC.) UNKNOWN. 3. PLEASE PROVIDE PATIENT DEMOGRAPHICS (GENDER, AGE, WEIGHT, RACE, ETHNICITY) AND COMORBIDITIES. IF UNAVAILABLE, PLEASE PROVIDE REASON WHY (E.G. HOSPITAL PRIVACY POLICY) I THOUGHT I CHOSE THE HOSPITAL PRIVATE POLICY. 4. DID THE BALLOON BECOME FULLY DETACHED OR WAS IT DAMAGED INTACT? IT LOOKS LIKE IT'S DETACHED. 5. HOW WAS THE BALLOON FRAGMENT(S) REMOVED FROM THE PATIENT? HE REMAINS WITH A WALL STENT COVERING. 6. IF FRAGMENT(S) REMAIN IN VIVO - DOES THE PHYSICIAN HAVE ANY CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUTCOMES? THE HOSPITAL SHOULD BE SENDING INFORMATION. 7. WHAT IS THE STATUS OF THE PATIENT? UNKNOWN. SECOND ADDITIONAL INFORMATION WAS RECEIVED ON 3/13/2026: 1. PROVIDE A DETAILED SUMMARY OF EVENT FROM BEGINNING TO END, INCLUDING TROUBLESHOOTING AND RESOLUTION. IT SEEMS THEY WERE USING THIS IN A MINE CORON

  Patient problems: Foreign Body In Patient

  MAUDE report 24696380 ↗