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Stellarex AB35SX060200135 (UDI 00813132026981)Recalls & reported problems

Spectranetics Corporation · Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 200mm) x 135cm · Class 3

All models of Stellarex (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813132026981), received between May 21, 2021 and Jun 15, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 Rupture4

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 15, 2022Material Rupture; Material Rupture

    TWO STELLAREX DEVICES WERE USED IN A SLIGHTLY TORTUOUS AND MODERATELY CALCIFIED SFA. DURING INFLATION OF THE FIRST STELLAREX DEVICE (MDR 3011416935-2022-00010), THE BALLOON RUPTURED AT 6 ATM. THE BALLOON WAS REMOVED IN ONE PIECE AND A NEW STELLAREX DEVICE WAS USED. DURING INFLATION OF THE SECOND STELLAREX DEVICE, THE BALLOON RUPTURED AT 5 ATM. THE BALLOON WAS ALSO REMOVED IN ONE PIECE AND THE PROCEDURE WAS COMPLETED WITH A NON-STELLAREX DEVICE. 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 14709309 ↗
  • MalfunctionJun 1, 2022Material Rupture; Material Rupture

    THE STELLAREX DEVICE WAS USED IN A SEVERELY CALCIFIED PROXIMAL SFA. DURING INFLATION AT 2 ATM, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED IN ONE PIECE AND THE PROCEDURE WAS COMPLETED WITH A NEW STELLAREX DEVICE. 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 14569454 ↗
  • MalfunctionOct 26, 2021Material Rupture; Material Rupture

    THE STELLAREX DEVICE WAS USED TO TREAT A MODERATELY TORTUOUS AND A SEVERELY CALCIFIED MID SFA. DURING INFLATION AT 2 ATM, THE BALLOON BURST DUE TO HEAVILY CALCIFIED EDGES. THE BALLOON WAS REMOVED IN ONE PIECE AND THE PROCEDURE WAS COMPLETED WITH A NEW STELLAREX DEVICE. 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 12701517 ↗
  • MalfunctionMay 21, 2021Material Rupture; Material Rupture

    FROM A RETROGRADE FEMORAL APPROACH, THE STELLAREX DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID SFA. DURING INFLATION AT 8 ATM, THE DEVICE BURST. NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11864273 ↗

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Sources and updates

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