REBEL™ H7493927428400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844013), received between Dec 11, 2019 and Feb 15, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P130030); they may or may not involve this specific model.

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

Recent adverse event reports

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

• MalfunctionFeb 15, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 28 X 4.00 REBEL BMS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE ADVANCING IT OVER THE WIRE, THE SHAFT BREAK. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538708 ↗
• InjuryNov 17, 2020Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK, UNRETRIEVED DEVICE FRAGMENTS, AND SURGICAL INTERVENTION OCCURRED. DURING A PERIPHERAL CASE, A 28MM X 4.00MM REBEL STENT BALLOON EXPANDABLE WAS USED FOR TREATMENT, BUT THE STENT BECAME STUCK IN THE ARTERY. THE STENT STRIPPED OFF THE DEVICE, THE SHAFT WAS SEPARATED, AND AS LEFT INSIDE THE PATIENT. THE PATIENT WAS SENT TO SURGERY FOR THE UNRETRIEVED DEVICE FRAGMENT. THE PROCEDURE WAS COMPLETED AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. IT WAS LATER REPORTED THAT THE TARGET LESION WAS LOCATED IN SUPERFICIAL FEMORAL ARTERY (SFA) AND OVER THE ARCH. IT WAS NOTED THAT THE REASON FOR THE EVENT WAS LIKELY DUE TO CALCIFICATIONS IN THE VESSEL AND THE ANGLE OF THE PURCHASE IN THE ARCH. THE EVENT LIKELY OCCURRED WHILE ADVANCING THE DEVICE AND BECAME STUCK. IT WAS ADDITIONALLY NOTED THAT WHILE PULLING BACK THE WIRE, IT LIKELY BENT OVER AT THE END OF THE DEPLOYMENT CATHETER AND THEN RUBBED ON THE EDGE OF A CALCIFICATION. THE DETACHED PORTION WAS SURGICALLY REMOVED FROM THE PATIENT. A CUT DOWN WAS DONE IN THE OPERATING ROOM (OR) UNDER ANESTHESIA, THE WIRE SECTION WAS REMOVED, AND THE PATIENT WAS CLOSED UP. NO ADDITIONAL PATIE

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Code Available

  MAUDE report 10852480 ↗
• MalfunctionApr 8, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 28 X 4.00 REBEL BMS STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE STENT STRUTS WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9935907 ↗
• MalfunctionDec 11, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. A 28 X 4.00 REBEL STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT WAS CRUMPLED UP AND THERE WAS DAMAGE ON THE STRUTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9454215 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P130030. One submission often covers many models, so check the product and lot details in each record.

• Z-0580-2020 · Oct 24, 2019 · Terminated
  Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chro