OPN NC 300-015-004Recalls & reported problems
SIS Medical AG · OPN NC Ø3.0x15 PTCA catheters · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640142570578), received between Nov 22, 2023 and Aug 6, 2026 — classified as 3 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Break1
- Improper or Incorrect Procedure or Method1
- Material Rupture1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Break; Stretched; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50153564 ↗MalfunctionJan 3, 2025Material Rupture; Material Rupture
IT HAS BEEN REPORTED BY THE PHYSICIAN THAT THE BALLOON RUPTURED/BURST AFTER 5 SECONDS, AT INFLATION PRESSURE 30-35 ATM (WITH NO NODULAR CALCIUM). LESION DESCRIPTION AND LOCATION: LAD PROX. STENOSIS 90%. IT WAS CONFIRMED THAT THE PATIENT WAS NOT HARMED IN ANY WAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21073401 ↗MalfunctionNov 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
THE FOLLOWING EVENT WAS REPORTED. THE OPN NC WOULD NOT DELIVER THROUGH A CONCENTRIC HIGHLY CALCIFIED LCX LESION IN SEVERAL ATTEMPTS. THE PHYSICIAN REPORTED THAT CATHETER FRICTION WAS FELT DURING INSERTION AND THE SHAFT BROKE PROXIMALLY. THE EVENT DID NOT AFFECT THE PATIENT, WHO WAS DISCHARGED HOME AFTER THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18196188 ↗
Other Catheters, Transluminal Coronary Angioplasty, Percutaneous devices
- MINI TREK™ 1012270-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous223 reports
- 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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