REBEL™ H7493927412450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729843740), received between Nov 8, 2017 and Feb 20, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY (LM). A 12 X 4.50MM REBEL STENT WAS ADVANCED FOR TREATMENT; HOWEVER, THE STENT CAME OFF THE DELIVERY SYSTEM IN THE FALSE LUMEN IN LM. THE PHYSICIAN WAS ABLE TO IMPLANT ANOTHER STENT IN THE TRUE LUMEN OF THE LM WHICH ALSO WAS ABLE TO SECURE THE DISLODGED STENT IN THE FALSE LUMEN OF THE LM. THE PROCEDURE WAS COMPLETED WITH PATIENT'S STATUS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8353811 ↗
• InjuryNov 8, 2017Fracture; Fracture

  DURING LMT, ANGIOPLASTY BALLOON FROM REBEL MONORAIL PLATINUM CHROMIUM CORONARY STENT SYSTEM BROKE AND WAS LODGED IN LMT. THE BALLOON WAS NOT ABLE TO BE REMOVED PERCUTANEOUSLY REQUIRING OPEN HEART SURGERY TO REMOVE THE BALLOON. AFTER THE BALLOON WAS DEFLATED, THE PHYSICIAN COULD NOT PULL IT OUT OF THE DEPLOYED STENT. AFTER PULLING ON THE SHAFT OF THE BALLOON IN A FINAL ATTEMPT, THE CATHETER BROKE.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7013186 ↗

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