REBEL™ H7493927424450Recalls & reported problems
Boston Scientific Corporation · Platinum Chromium Coronary Stent System · Class 3 · Implant
All models of REBEL (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729843955), received between Nov 26, 2018 and Dec 10, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
Device problems
- Material Deformation2
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED MID RIGHT CORONARY ARTERY. A 24 X 4.50 REBEL BMS STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE STENT WAS TAKEN OUT TO DO SOME BALLOONING, IT WAS NOTED THAT A STENT STRUT WAS LIFTED. A 20 X 4.50 REBEL BMS STENT WAS ADVANCED BUT EVEN WITH BALLOONING, THIS STENT ALSO GOT CAUGHT IN THE CALCIUM AND WAS DEFORMED. THE PROCEDURE WAS ABORTED AND THE PATIENT DID NOT GET A STENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9448734 ↗MalfunctionNov 26, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 24 X 4.50MM REBEL BMS STENT, IT WAS NOTED THAT THE STENT STRUT WAS BENT. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NEW REBEL STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8104079 ↗
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 · TerminatedRebel 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
Other STENT, CORONARY devices
- WALLSTENT® Endoprosthesis H965403130Boston Scientific Corporation · STENT, CORONARY35 reports
- WALLSTENT® Endoprosthesis H965402130Boston Scientific Corporation · STENT, CORONARY23 reports
- Tryton Side Branch Stent T5-2530-191-USTryton Medical, Inc. · Stent, Coronary1 death22 reports
- WALLSTENT® Endoprosthesis H965403330Boston Scientific Corporation · STENT, CORONARY21 reports
- WALLSTENT® Endoprosthesis H965403320Boston Scientific Corporation · STENT, CORONARY10 reports
- WALLSTENT® Endoprosthesis H965403120Boston Scientific Corporation · STENT, CORONARY9 reports
- Tryton Side Branch Stent T5-3035-151-USTryton Medical, Inc. · Stent, Coronary2 deaths7 reports
- MULTI-LINK VISION 1007850-15Abbott Vascular Inc. · STENT, CORONARY7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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