OPN NC 350-010-004Recalls & reported problems
SIS Medical AG · OPN NC Ø3.5x10 PTCA catheters · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640142570592), received between Nov 22, 2023 and Nov 22, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED FROM THE INSTITUTION THAT DURING A PERCUTANEOUS VENTRICULAR ASSIST DEVICE REMOVAL (PVAD) AN OPN NC BALLOON WAS DILATED TO 28 ATM DURING 4 INFLATIONS WITH THE SPECIFIED PRODUCT INDEFLATOR. BALLOON FUNCTIONED AS EXPECTED BUT UPON REMOVAL FROM THE ARTERY INTO THE GUIDE CATHETER, THE BALLOON SHAFT FRACTURED IN THE GUIDE CATHETER. BALLOON CATHETER WAS UNABLE TO SAFELY BE REMOVED FROM GUIDE CATHETER. DECISION WAS MADE TO REMOVE THE GUIDE CATHETER WITH THE FRACTURED OPN BALLOON INSIDE. AFTER REMOVAL FROM PATIENT BODY, BALLOON CATHETER WAS PULLED OUT OF GUIDE CATHETER AND GUIDE CATHETER WAS FLUSHED TO CONFIRM ALL PARTS WERE ACCOUNTED FOR. NO FOREIGN BODY RETAINED. GUIDEWIRES (ASAHI SION BLUE), BALLOON, AND GUIDE CATHETER ALL REMOVED AS SINGLE UNIT AND REPLACED WITH NEW EQUIPMENT TO COMPLETE PROCEDURE. SIS MEDICAL WAS INFORMED, THAT NO PATIENT INJURIES OCCURRED AND THE PATIENT WAS DISCHARGED HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18196128 ↗
Other Catheters, Transluminal Coronary Angioplasty, Percutaneous devices
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- 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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