REBEL™ H7493927420350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729843863), received between Mar 26, 2019 and May 3, 2021 — classified as 1 death, 1 injury.

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.

• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN AND INFECTION. IN (B)(6) 2017, A 20 X 3.50 REBEL STENT WAS IMPLANTED IN THE LEFT FEMORAL ARTERY. HOWEVER, IN (B)(6) 2018, THE AFOREMENTIONED STENT FAILED CAUSING SEVERE PAIN AND MEDICAL COMPLICATIONS THAT HAD TO BE CORRECTED VIA EMERGENCY SURGERY. AS A RESULT OF THE FAILURE OF THE STENT, THE PATIENT INCURRED AN INFECTION IN HIS LEG. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11767708 ↗
• DeathMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEATH OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT WAS SCHEDULED FOR A PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE AS THE PATIENT WAS TURNED DOWN BY SURGEON FOR BYPASS SURGERY. A 3.0 X 20 SYNERGY STENT WAS PLACED IN THE DISTAL LAD, A 3.5 X 38 SYNERGY STENT WAS THEN PLACED IN THE MID LAD, AND THEN A 3.5 X 16 SYNERGY STENT WAS PLACED IN THE PROXIMAL LAD. A FINAL ANGIOGRAM IMAGE SHOWED GOOD BLOOD FLOW AND THE PROCEDURE WAS FINISHED. WHILE THE PATIENT WAS IN RECOVERY, THE PATIENT CODED THIRTY MINUTES POST PROCEDURE AND WAS THEN BROUGHT BACK TO THE CATH LAB. AT THAT TIME, IT WAS DISCOVERED THAT THE THREE SYNERGY STENTS HAD CLOSED DOWN. THE LAD WAS THROMBOSED UP TO THE PROXIMAL EDGE OF THE 3.5 X 16 SYNERGY STENT. THE PHYSICIAN WIRED AND THEN BALLOONED THE DISTAL TO PROXIMAL LAD AND THEN IMPLANTED A 20 X 3.5 REBEL STENT BALLOON IN THE PROXIMAL SEGMENT OF THE LAD. A NON BSC ASPIRATION CATHETER DEVICE WAS ALSO USED TO RESTORE BLOOD FLOW. AN ADDITIONAL 10,000 UNITS OF HEPARIN WERE GIVEN ALONG WITH OTHER MEDICATIONS. THE PATIENT EXPIRED AT THE END OF THE SECOND PROCEDURE WHILE STILL IN THE CA

  Patient problems: Death

  MAUDE report 8451879 ↗

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