Marvel™ H749393011900Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729887782), received between Aug 26, 2019 and Mar 3, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID CIRCUMFLEX ARTERY. A 6F GUIDEZILLA II, AN OPTICROSS HD AND A MARVEL GUIDEWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT UPON CROSSING THE PROXIMAL LESION, THE PHYSICIAN FELT RESISTANCE, THEN TURNED OFF IMAGING AND HAD TO PULL OUT ALL THREE DEVICES AS A UNIT. FURTHERMORE, THE MARVEL GUIDEWIRE OR GUIDEZILLA COULD NOT SEPARATE FROM THE OPTICROSS. THE PROCEDURE WAS COMPLETED WITH THE USE OF A DIFFERENT NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510676 ↗
• InjuryMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT AND AN UNRETRIEVED DEVICE FRAGMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 190CM STRAIGHT-TIP (POUCH) MARVEL GUIDEWIRE WAS SELECTED FOR USE. IT WAS NOTED THAT THE DIFFICULT LESION HAD A CALCIFIC LEDGE. DURING THE PROCEDURE, THE INSERTED GUIDEWIRE BECAME STUCK IN THE CALCIUM UPON RETRACTION. THE GUIDEWIRE, NON-BOSTON SCIENTIFIC (BSC) BALLOON, AND NON-BSC GUIDE EXTENDER WERE PULLED BACK SIMULTANEOUSLY AS ONE UNIT BY THE PHYSICIAN. HOWEVER, UPON FULL REMOVAL OF THE GUIDEWIRE, IT WAS NOTED THAT APPROXIMATELY 1 CENTIMETER OF THE DISTAL TIP HAD BROKEN OFF AND WAS SEEN IN A DISTAL BRANCH OF THE VESSEL. SNARING WAS ATTEMPTED BUT FAILED DUE TO THE INABILITY TO CROSS THE LESION, AND THE FRAGMENT OF THE DEVICE WAS LEFT IN THE PATIENT. ANOTHER RETRIEVAL ATTEMPT WILL BE MADE WHEN THE PATIENT IS BROUGHT BACK FOR FURTHER TREATMENT. THE PATIENT FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19234433 ↗
• InjuryOct 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DISTAL TIP DETACHMENT OCCURRED AND THE DEVICE WAS RETRIEVED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 190CM, STRAIGHT-TIP MARVEL GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE TIP BROKE OFF WHILE ATTEMPTING TO CROSS THE LESION. THE DEVICE WAS RETRIEVED FROM THE PATIENT AND NO PRODUCT WAS LEFT IN THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726250 ↗
• MalfunctionOct 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED MID CIRCUMFLEX ARTERY. A 190CM MARVEL GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. HOWEVER, WHILE ATTEMPTING TO CROSS THE LESION, THE RADIOPAQUE PORTION OF THE WIRE BROKE OFF. IT WAS THE THEN NOTED THAT THE BODY OF WIRE WAS INSIDE THE THREADER BALLOON. THE DEVICES WERE COMPLETELY REMOVED TOGETHER AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726087 ↗
• InjuryAug 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AFTER THE LESION WAS WIRED, THE PROXIMAL RCA WAS STENTED AND THE ORIGINAL WIRE WAS INSERTED INTO THE MARGINAL BRANCH. ANOTHER WIRE WAS NEEDED DOWN THE RCA AND A 190CM MARVEL GUIDE WIRE WAS THEN ADVANCED. HOWEVER, THE WIRE APPEARED TO BE BEHIND THE STENT WHEN TRYING TO REMOVE IT AND THE WIRE CAME APART. THE WIRE WAS SNARED NUMEROUS TIMES AND EVENTUALLY THE WIRE WAS ABLE TO BE RETRIEVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8929873 ↗