Stellarex 0.035" OTW drug-coated angioplasty balloon AB35SX060200135Recalls & reported problems
Philips Image Guided Therapy Corporation · 6mm x 200mm x 135cm · Class 3
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 00810060550427), received between Oct 9, 2024 and Jul 7, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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 Rupture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2025Material Rupture; Material Rupture
A STELLAREX DEVICE WAS USED IN THE MID SFA. DURING THE FIRST INFLATION AT 6 ATM, THE BALLOON RUPTURED. A NEW STELLAREX DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED PER FDA REQUEST BECAUSE THE BALLOON RUPTURED BELOW RBP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411552 ↗MalfunctionOct 9, 2024Material Rupture; Material Rupture
A STELLAREX DEVICE WAS USED IN THE PROXIMAL POPLITEAL ARTERY AND DISTAL SFA. DURING INFLATION AT 1-2 ATM, THE BALLOON RUPTURED. A NEW STELLAREX DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED PER FDA REQUEST BECAUSE THE BALLOON RUPTURED BELOW RBP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20407798 ↗
Other Drug-Eluting Peripheral Transluminal Angioplasty Catheter devices
- LUTONIX® Drug Coated Balloon LX351305150Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter117 reports
- LUTONIX® Drug Coated Balloon LX351306150Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter75 reports
- Ranger™ H74939419502010Boston Scientific Corporation · Drug-Eluting Peripheral Transluminal Angioplasty Catheter71 reports
- Ranger™ H74939419602010Boston Scientific Corporation · Drug-Eluting Peripheral Transluminal Angioplasty Catheter71 reports
- Lutonix® Drug Coated Balloon LX351305100Lutonix, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter66 reports
- IN.PACT™ Admiral™ ADM06004013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall12 reports
- IN.PACT™ Admiral™ ADM06015013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall11 reports
- IN.PACT™ Admiral™ ADM04015013PMedtronic, Inc. · Drug-Eluting Peripheral Transluminal Angioplasty Catheter1 recall8 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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