REBEL™ H7493927424250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729843900), received between Feb 27, 2019 and Oct 23, 2020 — classified as 2 deaths, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HYPOTENSION, VESSEL OCCLUSION AND DEATH OCCURRED. THE PATIENT PRESENTED WITH GASTROINTESTINAL BLEEDING AND DEVELOPED ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS TREATED WITH 24 X 2.50, 20 X 3.00 AND 24 X 2.50 REBEL BARE METAL STENTS. POST PROCEDURE, THE PATIENT BECAME AGITATED WITH HYPOTENSION. THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY, AND WAS CODED AND INTUBATED. A NON-BOSTON SCIENTIFIC TEMPORARY VENTRICULAR SUPPORT DEVICE WAS INSERTED. RE-CATHETERIZATION SHOWED TOTAL OCCLUSION IN THE LAD AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED. THE PATIENT CONTINUED TO REQUIRE CARDIOPULMONARY RESUSCITATION AND MULTIPLE VASOPRESSOR IN THE INTENSIVE CARE UNIT. THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death; Low Blood Pressure/ Hypotension; Stenosis

  MAUDE report 10729711 ↗
• DeathOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HYPOTENSION, VESSEL OCCLUSION AND DEATH OCCURRED. THE PATIENT PRESENTED WITH GASTROINTESTINAL BLEEDING AND DEVELOPED ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS TREATED WITH 24 X 2.50, 20 X 3.00 AND 24 X 2.50 REBEL BARE METAL STENTS. POST PROCEDURE, THE PATIENT BECAME AGITATED WITH HYPOTENSION. THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY, AND WAS CODED AND INTUBATED. A NON-BOSTON SCIENTIFIC TEMPORARY VENTRICULAR SUPPORT DEVICE WAS INSERTED. RE-CATHETERIZATION SHOWED TOTAL OCCLUSION IN THE LAD AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED. THE PATIENT CONTINUED TO REQUIRE CARDIOPULMONARY RESUSCITATION AND MULTIPLE VASOPRESSOR IN THE INTENSIVE CARE UNIT. THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Death; Low Blood Pressure/ Hypotension; Stenosis

  MAUDE report 10729485 ↗
• MalfunctionApr 1, 2019Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08 MAR 2019. IT WAS REPORTED THAT SHAFT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED POSTERIOR TIBIAL ARTERY. AFTER A 45CM 5FR NON-BSC SHEATH WAS PLACED AND PRE-DILATATION WAS PERFORMED WITH 2MM AND 2.5MM BALLOON CATHETERS, A 24 X 2.50 REBEL STENT WAS SELECTED FOR USE. HOWEVER, UPON PASSING THROUGH THE SHEATH, THE DELIVERY BALLOON CATHETER WAS DAMAGED AND THE DEVICE WAS WITHDRAWN. SUBSEQUENTLY, ANOTHER 24 X 2.50 REBEL STENT WAS ADVANCED; HOWEVER, IT WAS NOTED THAT THE CATHETER BROKE ABOUT 25CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.5MM X 16MM REBEL STENT THAT WAS SUCCESSFULLY DEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE DETACHED/SEPARATED AND STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8469298 ↗
• MalfunctionFeb 27, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED POSTERIOR TIBIAL ARTERY. AFTER A 45CM 5FR NON-BSC SHEATH WAS PLACED AND PRE-DILATATION WAS PERFORMED WITH 2MM AND 2.5MM BALLOON CATHETERS, A 24 X 2.50 REBEL STENT WAS SELECTED FOR USE. HOWEVER, UPON PASSING THROUGH THE SHEATH, THE DELIVERY BALLOON CATHETER WAS DAMAGED AND THE DEVICE WAS WITHDRAWN. SUBSEQUENTLY, ANOTHER 24 X 2.50 REBEL STENT WAS ADVANCED; HOWEVER, IT WAS NOTED THAT THE CATHETER BROKE ABOUT 25CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.5MM X 16MM REBEL STENT THAT WAS SUCCESSFULLY DEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8376179 ↗

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