Sapphire NC 24 Coronary Dilatation Catheter 492502612Recalls & reported problems
OrbusNeich Medical (ShenZhen) Co., Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955905360), received between Nov 17, 2023 and Nov 17, 2023 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Perforation of Vessels2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SAPPHIRE BALLOON WAS USED FOR TREATMENT. A PERFORATION WAS OBSERVED. A COVERED STENT PLACEMENT WAS PERFORMED TO TREAT THE PERFORATION AND COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.
Patient problems: Perforation of Vessels
MAUDE report 18164680 ↗InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SAPPHIRE BALLOON WAS USED FOR TREATMENT. A PERFORATION WAS OBSERVED. A COVERED STENT PLACEMENT WAS PERFORMED TO TREAT THE PERFORATION AND COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.
Patient problems: Perforation of Vessels
MAUDE report 18164651 ↗
Other Catheters, Transluminal Coronary Angioplasty, Percutaneous devices
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- Maverick²™ H7493892815200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous1 death203 reports
- MINI TREK™ 1012270-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous162 reports
- Maverick²™ H7493892820200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous161 reports
- NC TREK 1012454-08Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 recalls59 reports
- TREK™ 1012272-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 deaths158 reports
- NC TREK 1012453-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall84 reports
- NC TREK 1012453-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death83 reports
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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