Sapphire II Pro 210-153-5UURecalls & reported problems
OrbusNeich Medical (ShenZhen) Co., Ltd. · Balloon Dilatation Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955942044), received between Oct 11, 2019 and Dec 8, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Material Rupture1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Material Rupture
THE 1.0 SAPPHIRE BALLOON RUPTURED WHEN INFLATED IN THE LAD [LEFT ANTERIOR DESCENDING].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23736478 ↗MalfunctionOct 11, 2019Defective Device
CUSTOMER COMPLAINT ALLEGES DEVICE MALFUNCTION; MID LEFT CIRCUMFLEX CORONARY ARTERY, VERY TIGHT LESION, MODERATE CALCIFICATION. A CIRCUMFLEX WITH A VERY TIGHT LESION. IT WAS FIRST ATTEMPTED TO PREDILATE THE LESION WITH A BIGGER BALLOON (YOU SEE 2 MARKERS). WHEN THIS DID NOT WORK THE SAPPHIRE II PRO 1,0 X 15 (FA1804585) WAS USED, WHICH ONE CENTRAL MARKER OF THE SAPPHIRE II PRO 1,0 X 15. THE MARKER OF THE 1,0 X 15 SAPPHIRE II PRO HAS BECOME DETACHED DURING PROCEDURE. THE OPERATOR TOOK OUT THE SAPPHIRE II PRO 1,0 X 15 AND FOUND THAT THE MARKER WAS GONE (STILL IN THE PATIENT) AND THAT THERE WAS ALSO BALLOON MATERIAL STILL IN THE PATIENTS CIRCUMFLEX (THE RETRIEVED BALLOON IS RETURNED TOGETHER WITH THIS COMPLAINT FORM). THE SAPPHIRE II PRO 1,0 X 15 HAS NEVER BEEN INFLATED. ALL OF THIS HAPPENED WITHOUT INFLATING THE BALLOON. ANOTHER BALLOON (2 MARKERS) THAT HAS BEEN USED TO PREDILATE AND TO PUSH THE LEFT BEHIND BALLOON MATERIAL FROM THE SAPPHIRE II PRO 1,0 X 15 AGAINST THE ARTERIAL WALL. STENT IS DEPLOYED, HOPEFULLY JAILING THE LEFT BEHIND BALLOON MATERIAL (WHICH YOU CANNOT SEE BECAUSE IT IS NOT RADIO-OPAQUE) IN BETWEEN THE STENT AND THE ARTERIAL WALL. IT CAN BE SEEN IN THIS VIDEO THAT IN
Patient problems: Foreign Body In Patient
MAUDE report 9178255 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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