REBEL™ H7493927420250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729843832), received between Nov 14, 2018 and Jan 6, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 20 X 2.50 REBEL STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS TAKEN OUT FROM THE PACKAGE, THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11123705 ↗
• MalfunctionNov 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 20 X 2.50 REBEL STENT WAS SELECTED FOR USE. HOWEVER, UPON REMOVING THE DEVICE FROM THE HOOP, THE STENT WAS STRIPPED OFF AND WAS LEFT ON THE STYLET. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9391970 ↗
• MalfunctionNov 14, 2018Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY WAS ENCOUNTERED AND THE SHAFT BROKE. THE 80% IN-STENT RESTENOSED LESION WAS IN THE CALCIFIED DISTAL RIGHT CORONARY ARTERY. PRE-DILATION WAS PERFORMED WITH MULTIPLE COMPLIANT AND NON-COMPLIANT BALLOON CATHETERS. AFTER A 3.0MM STENT WAS PLACED IN THE MID RCA AND ADDITIONAL 20 X 2.50 REBEL BMS STENT WAS ADVANCED AND DEPLOYED IN THE DISTAL RCA. HOWEVER, THE DELIVERY SYSTEM WAS UNABLE TO BE RETRACTED OR PULLED OUT. THE DELIVERY SYSTEM WAS INFLATED MULTIPLE TIMES TRYING TO DISLODGE IT. THE PHYSICIAN CONTINUED TO PULL ON THE DELIVERY SYSTEM DURING REMOVAL ATTEMPTS BUT ENDED UP LOSING GUIDE PLACEMENT. THE GUIDE WIRE AND THE DELIVERY SYSTEM CAME OUT BUT THE BALLOON TIP WAS LEFT IN THE DISTAL RCA. NO PATIENT COMPLICATIONS WERE REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THIS TIME. RETURNED PRODUCT CONSISTED OF A REBEL BMS BALLOON CATHETER. THE REMAINDER OF THE DEVICE THAT RETURNED WERE VISUALLY AND MICROSCOPICALLY EXAMINED. VISUAL EXAMINATION REVEALED THAT THE DISTAL SECTION OF THE CATHETER IS MISSING. THE EXIT NOTCH, DISTAL SHAFT, ENTIRE GUIDEWIRE LUMEN, BALLOON, MARKER BANDS, TIP, AND STENT ARE ALL MISSING. FROM THE

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 8071876 ↗

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