Stellarex AB35SX060060135Recalls & reported problems
Spectranetics Corporation · Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 60mm) x 135cm · Class 3
All models of Stellarex (8)
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 00813132024291), received between Dec 23, 2019 and Feb 21, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3 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.
Most reported problems
Device problems
- Material Rupture3
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2023Material Rupture; Material Rupture
A STELLAREX DEVICE WAS USED IN THE MID SFA. DURING INFLATION AT 8 ATM, A BALLOON PINHOLE LEAK WAS OBSERVED, CAUSED BY A STENT STRUT INSIDE THE STENT. 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 16414810 ↗MalfunctionJun 30, 2020Material Rupture; Material Rupture
THE STELLAREX DEVICE WAS USED IN A SEVERELY CALCIFIED AND SLIGHTLY TORTUOUS MID SFA. DURING INFLATION AT NOMINAL PRESSURE FOR THIRTY SECONDS, THE BALLOON RUPTURED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10215793 ↗MalfunctionDec 23, 2019Material Rupture; Material Rupture
DURING INFLATION IN A CALCIFIED LESION, THE STELLAREX BALLOON BURST AT 8 PSI (5 ATM).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9513729 ↗
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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