Stellarex AB35SX060120135 (UDI 00813132023256)Recalls & reported problems
Spectranetics Corporation · Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 120mm) x 135cm · Class 3
All models of Stellarex (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00813132023256), received between Apr 18, 2018 and Sep 24, 2020 — classified as 1 injury, 11 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (11 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 Rupture11
- Deflation Problem1
Patient problems
- No Consequences Or Impact To Patient11
- Atherosclerosis1
- Peripheral Vascular Disease1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2020Material Rupture; Material Rupture
FROM A CONTRALATERAL FEMORAL APPROACH, THE STELLAREX DEVICE WAS USED IN A MODERATELY CALCIFIED MID POPLITEAL ARTERY. DURING INITIAL INFLATION BELOW NOMINAL PRESSURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10583770 ↗MalfunctionMar 31, 2020Material Rupture; Material Rupture
FROM THE CONTRALATERAL FEMORAL APPROACH,A STELLAREX DEVICE WAS INSERTED THROUGH A 6FR INTRODUCER SHEATH TO TREAT AN ISR IN THE LEFT SFA. THE BALLOON WAS INFLATED TO 6 ATM, BUT THE BALLOON RUPTURED. A NEW STELLAREX DEVICE WAS USED, BUT ALSO RUPTURED UPON INITIAL INFLATION. AN ABBOTT ARMADA BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9904445 ↗MalfunctionMar 6, 2020Material Rupture; Material Rupture
DURING INFLATION, A STELLAREX DCB WAS INFLATED TO 2 ATM AND IMMEDIATELY BURST WHILE INSIDE THE PATIENT. THE DEVICE WAS TAKEN OUT OF THE PATIENT AND A NEW STELLAREX BALLOON WAS USED TO FINISH THE CASE SUCCESSFULLY. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9801408 ↗MalfunctionJan 23, 2020Material Rupture; Material Rupture
THE STELLAREX DEVICE WAS USED IN A SEVERELY CALCIFIED AND TORTUOUS SFA LESION. DURING INFLATION FOR 30 SECONDS AT 10 ATM, THE BALLOON RUPTURED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9623892 ↗MalfunctionDec 29, 2019Material Rupture; Material Rupture
THE BALLOON WAS PRESSURIZED TO LESS THAN RBP, BUT WOULD NOT HOLD PRESSURE. A NEW STELLAREX DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9528630 ↗MalfunctionDec 23, 2019Material Rupture; Material Rupture
DURING INFLATION, THE STELLAREX BALLOON POPPED AT UNKNOWN PRESSURE. A NEW STELLAREX DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OCCURRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9513743 ↗MalfunctionDec 23, 2019Material Rupture; Material Rupture
POST LASER ATHERECTOMY, A STELLAREX BALLOON WAS UTILIZED IN A HEAVILY CALCIFIED LESION OF THE LEFT MID SFA. HOWEVER, THE BALLOON RUPTURED AT 10 ATM (BELOW RBP), POSSIBLY ON SOME RESIDUAL CALCIUM. THERE WAS NO PATIENT COMPLICATIONS. THE LESION WAS DILATED WITH A HIGH PRESSURE BALLOON, THEN BALLOONED WITH ANOTHER STELLAREX THAT PERFORMED TO SPECIFICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9513742 ↗MalfunctionDec 23, 2019Material Rupture; Material Rupture
DURING INFLATION, THE STELLAREX BALLOON RUPTURED AT 6 ATM. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9513740 ↗MalfunctionDec 23, 2019Material Rupture; Material Rupture
THE BALLOON WAS INFLATED AT NOMINAL PRESSURE FOR ABOUT 1.5 MINUTES, THEN PRESSURE WAS INCREASED A COUPLE MORE ATM (LESS THAN RPB) WHEN THE BALLOON RUPTURED. AFTER THE BALLOON WAS REMOVED FROM THE PATIENT, THE NURSE WIPED THE BALLOON CLEAN AND CONNECTED TO AN INDEFLATOR FOR INFLATION. ONCE INFLATED, IT WAS NOTICED THAT THE PROXIMAL END HAD A SMALL TEAR APPROXIMATELY 1 MM LONG. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DCB DEVICE. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9513736 ↗MalfunctionDec 23, 2019Material Rupture; Material Rupture
STELLAREX BALLOON WOULD NOT HOLD PRESSURE/ FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED USING A NEW STELLAREX DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9513732 ↗MalfunctionDec 23, 2019Material Rupture; Material Rupture
STELLAREX BURST WHEN INFLATED TO NOMINAL PRESSURE AT 8 ATM. A NEW STELLAREX BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9513731 ↗InjuryApr 18, 2018Deflation Problem; Deflation Problem
Patient problems: Atherosclerosis; Peripheral Vascular Disease
MAUDE report 7441379 ↗
Other Drug-Eluting Peripheral Transluminal Angioplasty Catheter devices
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- 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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