Sapphire NC 24 Coronary Dilatation Catheter 492501512Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06934955905339), received between May 29, 2025 and May 29, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• InjuryMay 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING PROCEDURE TO TREAT HEAVILY CALCIFIED POSTERIOR LATERAL ARTERY, THE SAPPHIRE BALLOON WAS INFLATED TWICE. THE BALLOON DID NOT INFLATE COMPLETELY. THE BALLOON WAS DEFLATE AND DURING REMOVAL, THE DISTAL PART OF THE BALLOON CAME OFF AND THE FRAGMENT WAS LEFT INSIDE THE ARTERY. THERE WAS DISSECTION IN THE RCA AND AN ABBOTT STENT WAS USED. IT IS UNKNOWN IF DISSECTION WAS CAUSED DUE TO THE SAPPHIRE BALLOON OR THE PROCEDURE. THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 2025/5/21: 1. THE SAPPHIRE NC 24 BALLOON WAS THE FIRST BALLOON USED TO INFLATE. 2. THE SPECIFIC VESSEL LOCATION(S) THAT SAPPHIRE BALLOON INFLATED WAS THE POSTERIOR LATERAL ARTERY. 3. THE SAPPHIRE BALLOON WAS INFLATED TO 18 ATMOSPHERES. 4. THE VESSEL WAS 90% STENOSED. THE DIAMETER OF THE INFLATED VESSEL WAS UNAVAILABLE. 5. IT IS UNKNOWN IF ANY RESISTANCE OR ABNORMALITY FELT DURING THE BALLOON REMOVAL. 6. THE DISSECTION OCCUR IN THE MID OF RCA. 7. IN THE OPINION OF THE PHYSICIAN, THE CAUSE OF DISSECTION WAS THE LESION AND NOT THE SAPPHIRE BALLOON. 8. THE DISSECTION WAS NON-FLOW LIMITING.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 22111538 ↗
• InjuryMay 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING PROCEDURE TO TREAT HEAVILY CALCIFIED POSTERIOR LATERAL ARTERY, THE SAPPHIRE BALLOON WAS INFLATED TWICE. THE BALLOON DID NOT INFLATE COMPLETELY. THE BALLOON WAS DEFLATE AND DURING REMOVAL, THE DISTAL PART OF THE BALLOON CAME OFF AND THE FRAGMENT WAS LEFT INSIDE THE ARTERY. THERE WAS DISSECTION IN THE RCA AND AN ABBOTT STENT WAS USED. IT IS UNKNOWN IF DISSECTION WAS CAUSED DUE TO THE SAPPHIRE BALLOON OR THE PROCEDURE. THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 2025/5/21: 1. THE SAPPHIRE NC 24 BALLOON WAS THE FIRST BALLOON USED TO INFLATE. 2. THE SPECIFIC VESSEL LOCATION(S) THAT SAPPHIRE BALLOON INFLATED WAS THE POSTERIOR LATERAL ARTERY. 3. THE SAPPHIRE BALLOON WAS INFLATED TO 18 ATMOSPHERES. 4. THE VESSEL WAS 90% STENOSED. THE DIAMETER OF THE INFLATED VESSEL WAS UNAVAILABLE. 5. IT IS UNKNOWN IF ANY RESISTANCE OR ABNORMALITY FELT DURING THE BALLOON REMOVAL. 6. THE DISSECTION OCCUR IN THE MID OF RCA. 7. IN THE OPINION OF THE PHYSICIAN, THE CAUSE OF DISSECTION WAS THE LESION AND NOT THE SAPPHIRE BALLOON. 8. THE DISSECTION WAS NON-FLOW LIMITING.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 22111468 ↗
• InjuryMay 29, 2025Material Separation; Material Separation

  DURING PROCEDURE TO TREAT 90% STENOSED HEAVILY CALCIFIED POSTERIOR LATERAL ARTERY, THE SAPPHIRE BALLOON WAS INFLATED TWICE AT 18 ATMOSPHERES. THE BALLOON DID NOT INFLATE COMPLETELY. THE BALLOON WAS DEFLATED AND DURING REMOVAL, THE DISTAL PART OF THE BALLOON CAME OFF AND THE FRAGMENT WAS LEFT INSIDE THE ARTERY. THERE WAS NON-FLOW LIMITING DISSECTION IN THE MID RCA AND AN ABBOTT DRUG ELUTING STENT WAS USED TO TREAT THE DISSECTION. IN THE OPINION OF THE PHYSICIAN, THE CAUSE OF DISSECTION WAS THE LESION AND NOT SAPPHIRE BALLOON. THE PATIENT WAS STABLE.

  Patient problems: Embolism/Embolus; Foreign Body In Patient; Vascular Dissection

  MAUDE report 22108284 ↗