REBELRecalls & reported problems across all models

We found 24 models of REBEL by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2017 and Apr 12, 2022 — classified as 6 deaths, 7 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported REBEL problems

REBEL models

24 models, most reported first. Each model has its own page with its reports, recalls and device details.

• REBEL™ H7493927424250

  STENT, CORONARY
  2 deaths4 reports
• REBEL™ H7493927428400

  STENT, CORONARY
  4 reports
• REBEL™ H7493927432300

  STENT, CORONARY
  4 reports
• REBEL™ H7493927416400

  STENT, CORONARY
  3 reports
• REBEL™ H7493927420250

  STENT, CORONARY
  3 reports
• REBEL™ H7493927412450

  STENT, CORONARY
  2 reports
• REBEL™ H7493927420350

  STENT, CORONARY
  1 death2 reports
• REBEL™ H7493927420400

  STENT, CORONARY
  2 reports
• REBEL™ H7493927424450

  STENT, CORONARY
  2 reports
• REBEL™ H7493927408350

  STENT, CORONARY
  1 report
• REBEL™ H7493927412300

  STENT, CORONARY
  1 death1 report
• REBEL™ H7493927412350

  STENT, CORONARY
  1 report
• REBEL™ H7493927412400

  STENT, CORONARY
  1 report
• REBEL™ H7493927416300

  STENT, CORONARY
  1 report
• REBEL™ H7493927416450

  STENT, CORONARY
  1 report
• REBEL™ H7493927420270

  STENT, CORONARY
  1 death1 report
• REBEL™ H7493927420300

  STENT, CORONARY
  1 death1 report
• REBEL™ H7493927420450

  STENT, CORONARY
  1 report
• REBEL™ H7493927424300

  STENT, CORONARY
  1 report
• REBEL™ H7493927424350

  STENT, CORONARY
  1 report
• REBEL™ H7493927428300

  STENT, CORONARY
  1 report
• REBEL™ H7493927428450

  STENT, CORONARY
  1 report
• REBEL™ H7493927432350

  STENT, CORONARY
  1 report
• REBEL™ H7493927432400

  STENT, CORONARY
  1 report

Recent REBEL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 16 X 3.00 REBEL BMS STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT WAS DAMAGED UPON OPENING THE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14086338 ↗
• MalfunctionFeb 15, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 28 X 4.00 REBEL BMS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE ADVANCING IT OVER THE WIRE, THE SHAFT BREAK. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538708 ↗
• MalfunctionJul 16, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 16 X 4.00 REBEL STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE SHAFT WAS BROKEN IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12182249 ↗
• 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 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT AS SHAFT BREAK OCCURRED. A 32 X 4.00 REBEL BARE METAL STENT WAS SELECTED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT BROKE OFF DURING IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401793 ↗
• MalfunctionFeb 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OUTSIDE PATIENT OCCURRED. A 28 X 4.50 REBEL BMS STENT WAS ADVANCED FOR USE. HOWEVER, STENT WAS OFF THE BALLOON WHEN IT CAME OUT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273442 ↗
• 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 ↗
• DeathDec 8, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT DIED. A 12 X 3.00 REBEL STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS. THE PATIENT WENT INTO CARDIAC ARREST AND DIED.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 10971220 ↗
• InjuryNov 17, 2020Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK, UNRETRIEVED DEVICE FRAGMENTS, AND SURGICAL INTERVENTION OCCURRED. DURING A PERIPHERAL CASE, A 28MM X 4.00MM REBEL STENT BALLOON EXPANDABLE WAS USED FOR TREATMENT, BUT THE STENT BECAME STUCK IN THE ARTERY. THE STENT STRIPPED OFF THE DEVICE, THE SHAFT WAS SEPARATED, AND AS LEFT INSIDE THE PATIENT. THE PATIENT WAS SENT TO SURGERY FOR THE UNRETRIEVED DEVICE FRAGMENT. THE PROCEDURE WAS COMPLETED AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. IT WAS LATER REPORTED THAT THE TARGET LESION WAS LOCATED IN SUPERFICIAL FEMORAL ARTERY (SFA) AND OVER THE ARCH. IT WAS NOTED THAT THE REASON FOR THE EVENT WAS LIKELY DUE TO CALCIFICATIONS IN THE VESSEL AND THE ANGLE OF THE PURCHASE IN THE ARCH. THE EVENT LIKELY OCCURRED WHILE ADVANCING THE DEVICE AND BECAME STUCK. IT WAS ADDITIONALLY NOTED THAT WHILE PULLING BACK THE WIRE, IT LIKELY BENT OVER AT THE END OF THE DEPLOYMENT CATHETER AND THEN RUBBED ON THE EDGE OF A CALCIFICATION. THE DETACHED PORTION WAS SURGICALLY REMOVED FROM THE PATIENT. A CUT DOWN WAS DONE IN THE OPERATING ROOM (OR) UNDER ANESTHESIA, THE WIRE SECTION WAS REMOVED, AND THE PATIENT WAS CLOSED UP. NO ADDITIONAL PATIE

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Code Available

  MAUDE report 10852480 ↗
• 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 OCCURRED AND PATIENT DIED. 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 10729634 ↗
• 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 ↗
• MalfunctionOct 7, 2020Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL ARTERY. A 20 X 4.00MM REBEL BMS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THERE WAS DIFFICULTY ADVANCING THE GUIDE AND THE STENT STRUTS WERE BENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT WITH THE SAME GUIDEZILLA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10643220 ↗
• DeathAug 31, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PATIENT DIED. A 20 X 2.75 REBEL BMS STENT WAS SELECTED FOR USE. THE DEVICE WAS INSERTED IN THE ARTERY AND WAS PULLED OUT. HOWEVER, THE STENT MANGLED AND SLIPPED ON THE BALLOON. ONCE THE DEVICE WAS OUTSIDE THE PATIENT'S BODY, THE STENT FELL OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. BUT, THE PATIENT DIED.

  Patient problems: Death

  MAUDE report 10473378 ↗
• MalfunctionMay 14, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. A 32 X 3.00 REBEL BMS STENT WAS SELECTED FOR USE. HOWEVER, AFTER OPENING THE STENT, IT WAS NOTICED THAT THE STENT WAS ALREADY PARTIALLY DEPLOYED. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10057005 ↗

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