REBEL™ H7493927424350Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729843931), received between Nov 29, 2018 and Nov 29, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 29, 2018Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 24X3.50MM REBEL STENT, IT WAS NOTED THAT THE STENT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED AS THE DEVICE DID NOT ENTER THE PATIENT'S BODY. DEVICE EVALUATED BY MFR.: THE OUTER SHAFT, INNER SHAFT, BALLOON, STENT AND TIP WERE MICROSCOPICALLY EXAMINED. THERE ARE NUMEROUS SHAFT KINKS. THERE IS SHAFT DAMAGE AT THE EXIT NOTCH WHICH IS CONSISTENT WITH DAMAGE SEEN WITH THE USE OF A GUIDEWIRE. THE STENT IS DAMAGED 10MM FROM THE PROXIMAL MARKERBAND. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE AND THE REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 8115970 ↗
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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