StellarexRecalls & reported problems across all models

We found 8 models of Stellarex by Spectranetics Corporation in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2018 and Feb 21, 2023 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Stellarex problems

Stellarex models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Stellarex AB35SX060120135

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  12 reports
• Stellarex AB35SX060200135

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  4 reports
• Stellarex AB35SX060040135

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• Stellarex AB35SX060060135

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  3 reports
• Stellarex AB35SX060150135

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  2 reports
• Stellarex AB35SX050120135

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Stellarex AB35SX040200135

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report
• Stellarex AB35SX050200135

  Drug-Eluting Peripheral Transluminal Angioplasty Catheter
  1 report

Recent Stellarex adverse event reports

The 15 most recent reports across all models, 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 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, 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 (MDR 3011416935-2022-00011), 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 14709407 ↗
• 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 ↗
• MalfunctionOct 25, 2021Material Rupture; Material Rupture

  THE STELLAREX DEVICE WAS USED TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL SFA. DURING INFLATION AT LESS THAN 10 ATM, THE BALLOON BURST. THE BALLOON WAS REMOVED OVER THE WIRE AND IN ONE PIECE. 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 12693657 ↗
• 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 ↗
• MalfunctionApr 12, 2021Material Rupture; Material Rupture

  FROM A CONTRALATERAL FEMORAL APPROACH, THE STELLAREX DEVICE WAS USED TO TREAT THE PROXIMAL POPLITEAL ARTERY. DURING INFLATION AT 1 ATM, CONTRAST WAS VISIBLY LEAKING OUT OF THE BALLOON. THE BALLOON WAS REMOVED FROM THE BODY, INFLATED ON THE TABLE AND A PINHOLE ON THE BALLOON WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653902 ↗
• MalfunctionFeb 18, 2021Material Rupture; Material Rupture

  FROM A CONTRALATERAL FEMORAL APPROACH, THE STELLAREX DEVICE WAS USED TO TREAT A PRE-DILATED RIGHT MID SFA. DURING INFLATION BELOW NOMINAL PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11345001 ↗
• 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 ↗
• InjuryAug 11, 2020Difficult to Insert; Difficult to Insert

  THE STELLAREX DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED AND A SEVERELY TORTUOUS PROXIMAL CFA. THE PHYSICIAN ATTEMPTED TO LOAD THE STELLAREX OVER THREE DIFFERENT SIZE GUIDE WIRES (014, 018, 035), BUT WAS UNABLE TO PASS ALL THE WAY THROUGH THE 6F TERUMO DESTINATION SHEATH. THE STELLAREX WAS REMOVED FROM THE 035 GUIDE WIRE, WHICH REMAINED IN THE PATIENT. THE PHYSICIAN THEN REMOVED THE INTRODUCER SHEATH AND REPLACED IT WITH A NEW INTRODUCER SHEATH. AT THAT POINT, A NEW STELLAREX WAS LOADED OVER THE EXISTING 035 GUIDE WIRE AND WAS ABLE TO PASS THROUGH THE NEW INTRODUCER SHEATH WITH NO ISSUES. WHEN THE FIRST STELLAREX WAS REMOVED FROM THE PATIENT, THE PHYSICIAN DID NOT ATTEMPT TO LOAD THE NEW STELLAREX THROUGH THE FIRST INTRODUCER SHEATH. THEREFORE, IT IS UNKNOWN IF THE STELLAREX WAS UNABLE TO PASS DUE TO AN OCCLUDED GUIDE WIRE LUMEN (PREVENTING THE STELLAREX TO ADVANCE PAST THE INTRODUCER SHEATH) OR AN OCCLUDED INTRODUCER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394216 ↗
• 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 ↗
• 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 9906201 ↗
• 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 ↗

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