Promus PREMIERRecalls & reported problems across all models
Boston Scientific Corporation · 56 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 248
- Deaths reported
- 2
- Injuries reported
- 65
- Recalls
- 0
We found 56 models of Promus PREMIER by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 248 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2016 and Oct 12, 2023 — classified as 2 deaths, 65 injuries, 181 malfunctions.
The most frequently reported specific device problem is “Bent” (70 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
Reports received per month, all models
Most reported Promus PREMIER problems
Device problems
- Bent70
- Break52
- Device Dislodged or Dislocated51
- Device Damaged Prior to Use21
- Adverse Event Without Identified Device or Use Problem17
- Entrapment of Device17
- Difficult to Remove12
- Failure to Advance12
Patient problems
- No Consequences Or Impact To Patient166
- No Patient Involvement30
- No Known Impact Or Consequence To Patient21
- Thrombosis7
- Chest Pain5
- Occlusion4
- Angina3
- Cardiac Enzyme Elevation3
Promus PREMIER models
56 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Promus PREMIER™ H7493952838300Coronary drug-eluting stent13 reports
- Promus PREMIER™ H7493952838400Coronary drug-eluting stent12 reports
- Promus PREMIER™ H7493952816250Coronary drug-eluting stent11 reports
- Promus PREMIER™ H7493952812220Coronary drug-eluting stent10 reports
- Promus PREMIER™ H7493952812300Coronary drug-eluting stent10 reports
- Promus PREMIER™ H7493952820300Coronary drug-eluting stent8 reports
- Promus PREMIER™ H7493952832400Coronary drug-eluting stent8 reports
- Promus PREMIER™ H7493952838250Coronary drug-eluting stent1 death8 reports
- Promus PREMIER™ H7493952812250Coronary drug-eluting stent7 reports
- Promus PREMIER™ H7493952816300Coronary drug-eluting stent7 reports
- Promus PREMIER™ H7493952816350Coronary drug-eluting stent7 reports
- Promus PREMIER™ H7493952824300Coronary drug-eluting stent7 reports
- Promus PREMIER™ H7493952832220Coronary drug-eluting stent7 reports
- Promus PREMIER™ H7493952812350Coronary drug-eluting stent6 reports
- Promus PREMIER™ H7493952816220Coronary drug-eluting stent6 reports
- Promus PREMIER™ H7493952824270Coronary drug-eluting stent6 reports
- Promus PREMIER™ H7493952838350Coronary drug-eluting stent6 reports
- Promus PREMIER™ H7493952812400Coronary drug-eluting stent5 reports
- Promus PREMIER™ H7493952820220Coronary drug-eluting stent5 reports
- Promus PREMIER™ H7493952828220Coronary drug-eluting stent5 reports
- Promus PREMIER™ H7493952828270Coronary drug-eluting stent5 reports
- Promus PREMIER™ H7493952838270Coronary drug-eluting stent5 reports
- Promus PREMIER™ H7493952808220Coronary drug-eluting stent4 reports
- Promus PREMIER™ H7493952816400Coronary drug-eluting stent4 reports
- Promus PREMIER™ H7493952820250Coronary drug-eluting stent4 reports
- Promus PREMIER™ H7493952820350Coronary drug-eluting stent4 reports
- Promus PREMIER™ H7493952820400Coronary drug-eluting stent4 reports
- Promus PREMIER™ H7493952824250Coronary drug-eluting stent4 reports
- Promus PREMIER™ H7493952824400Coronary drug-eluting stent4 reports
- Promus PREMIER™ H7493952828250Coronary drug-eluting stent4 reports
- Promus PREMIER™ H7493952828350Coronary drug-eluting stent4 reports
- Promus PREMIER™ H7493952832250Coronary drug-eluting stent1 death4 reports
- Promus PREMIER™ H7493952832350Coronary drug-eluting stent4 reports
- Promus PREMIER™ H7493952808300Coronary drug-eluting stent3 reports
- Promus PREMIER™ H7493952820270Coronary drug-eluting stent3 reports
- Promus PREMIER™ H7493952824220Coronary drug-eluting stent3 reports
- Promus PREMIER™ H7493952832300Coronary drug-eluting stent3 reports
- Promus PREMIER™ H7493925212400Coronary drug-eluting stent2 reports
- Promus PREMIER™ H7493925216250Coronary drug-eluting stent2 reports
- Promus PREMIER™ H7493925224400Coronary drug-eluting stent2 reports
- Promus PREMIER™ H7493952808250Coronary drug-eluting stent2 reports
- Promus PREMIER™ H7493952808350Coronary drug-eluting stent2 reports
- Promus PREMIER™ H7493952812270Coronary drug-eluting stent2 reports
- Promus PREMIER™ H7493952824350Coronary drug-eluting stent2 reports
- Promus PREMIER™ H7493952828300Coronary drug-eluting stent2 reports
- Promus PREMIER™ H7493952828400Coronary drug-eluting stent2 reports
- Promus PREMIER™ H7493925208350Coronary drug-eluting stent1 report
- Promus PREMIER™ H7493925212220Coronary drug-eluting stent1 report
- Promus PREMIER™ H7493925216220Coronary drug-eluting stent1 report
- Promus PREMIER™ H7493925216350Coronary drug-eluting stent1 report
- Promus PREMIER™ H7493925224250Coronary drug-eluting stent1 report
- Promus PREMIER™ H7493925232270Coronary drug-eluting stent1 report
- Promus PREMIER™ H7493925232300Coronary drug-eluting stent1 report
- Promus PREMIER™ H7493952808270Coronary drug-eluting stent1 report
- Promus PREMIER™ H7493952816270Coronary drug-eluting stent1 report
- Promus PREMIER™ H7493952832270Coronary drug-eluting stent1 report
Recent Promus PREMIER adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 12, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2018, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. CORONARY ANGIOGRAPHY REVEALED A BIFURCATED MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80-90% DISEASE. THE TARGET LESION WAS DIRECTLY STENTED WITH A 16 X 2.50 PROMUS PREMIER DRUG ELUTING STENT RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS STABLE AND DISCHARGED ON DUAL ANTIPLATELET TREATMENT. ON (B)(6) 2023, THE PATIENT PRESENTED WITH UNSTABLE ANGINA, EXPERIENCING LEFT-SIDED CHEST PAIN RADIATING INTO THE LEFT SHOULDER AND DOWN THE LEFT ARM FOR 2 DAYS. HEPARIN DRIP WAS STARTED, AND THE PATIENT WAS STABLE, AND THEIR PAIN WAS RESOLVED. THE PATIENT WAS DIAGNOSED WITH NON-ST-ELEVATION MYOCARDIAL INFRACTION AND HYPERTENSION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. ANGIOGRAPHY REVEALED 99% IN-STENT RESTENOSIS OF THE PREVIOUSLY DEPLOYED PROMUS PREMIER DRUG ELUTING STENT. FOLLOWING PRE-DILATION WITH A 2.00 X 12 EMERGE BALLOON, SUCCESSFUL ANGIOPLASTY WAS PERFORMED USING A 2.75 X 22 NON-BSC DRUG ELUTING STENT. FOLLOWING POST DILATION THERE WAS NO RESIDUAL STENOSIS. THE PATIENT BECAME SEVERELY NAUSEATED AND HYPERTENSIVE POSSIBLY DUE TO A CONTRAST ALLERGY AND WAS GIVEN
Patient problems: Angina; High Blood Pressure/ Hypertension; Myocardial Infarction; Restenosis
MAUDE report 17924951 ↗InjuryMay 27, 2020Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE PATIENT WAS EXPOSED TO EXCESSIVE RADIATION. A 2.25 X 8MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION AND CAUSED A SIGNIFICANT DELAY TO THE PROCEDURE. THIS RESULTED TO PATIENT RECEIVING AN EXCESS RADIATION DOSE EXCEEDING 5 GYCM2. THE SECTION OF THE LESION COULD NOT BE STENTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Radiation Exposure, Unintended
MAUDE report 10093735 ↗InjuryMay 26, 2020Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE PATIENT WAS EXPOSED TO EXCESSIVE RADIATION. A 2.50 X 12MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND CAUSES A SIGNIFICANT DELAY TO THE PROCEDURE. THIS RESULTED TO PATIENT RECEIVING AN EXCESS RADIATION DOSE EXCEEDING 5 GYCM2. THE SECTION OF THE LESION COULD NOT BE STENTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Radiation Exposure, Unintended
MAUDE report 10088280 ↗MalfunctionMay 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00X38MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE LOADING THE DELIVERY SYSTEM ONTO A NON-BSC GUIDEWIRE, THE STENT CAME OFF THE BALLOON. THE STENT DELIVERY SYSTEM WAS PULLED OUT OFF THE WIRE AND THE PROCEDURE WAS COMPLETED WITH A 3.00X32MM SYNERGY DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10036566 ↗MalfunctionJan 30, 2020Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT STENT DAMAGE HAD OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS TO BE PERFORMED. DURING PREPARATION, THE PHYSICIAN TRIED LOADING THE 2.75 X 38MM PROMUS PREMIER DRUG-ELUTING STENT INTO THE WATCHDOG HEMOSTASIS VALVE AND IT CRUSHED THE STENT. THIS OCCURRED OUTSIDE OF THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT AND THE ORIGINAL WATCHDOG WITHOUT FURTHER ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9649091 ↗MalfunctionJan 24, 2020Inflation Problem; Material Deformation; Inflation Problem; Material Deformation
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2020. IT WAS REPORTED THAT BALLOON INFLATION FAILURE AND SHAFT KINK OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. A 4.00X38MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE SHAFT KINKED AND THE BALLOON WAS UNABLE TO INFLATE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9628938 ↗MalfunctionDec 20, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED AT THE LEFT CORONARY ARTERY. A 2.25X16MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE UNDEPLOYED STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9501330 ↗DeathDec 16, 2019Defective Device; Defective Device
SAME CASE AS MDR: (B)(4) AND (B)(4). IT WAS REPORTED THAT STENT PROFILE PROBLEM OCCURRED AND PATIENT EXPERIENCED ACUTE THROMBOSIS AND DIED. THE HIGHLY CALCIFIED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER CROSSING THE LESION WITH AN UNSPECIFIED GUIDEWIRE, TWO UNSPECIFIED BALLOON CATHETERS WERE ADVANCED WITH DIFFICULTY DUE TO THE CALCIFICATION. A 2.5X38MM PROMUS PREMIER DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE MID LAD. FOLLOWING IMPLANT, A DISTAL DISSECTION WAS NOTED ALONG WITH 18MM OF DISEASE THAT ALSO NEEDED TO BE TREATED. A 3.5X32MM PROMUS PREMIER DES WAS PROXIMALLY OVERLAPPED THE INITIALLY PLACED STENT. ANOTHER 2.5X32MM PROMUS PREMIER WAS ADVANCED DISTALLY THROUGH BOTH STENTS BUT WOULD NOT DELIVER DESPITE PUSHING HARD. THE DEVICE WAS REMOVED AND THE LESION WAS DILATED WITH AN UNSPECIFIED BALLOON CATHETER. THE 2.5X32MM STENT WAS READVANCED BUT WAS STILL UNSUCCESSFUL. THE DEVICE WAS REMOVED HOWEVER, THE STENT STARTED STRIPPING OFF THE BALLOON AND ACCORDIONED INSIDE THE PREVIOUS DEPLOYED STENTS. THE PHYSICIAN ATTEMPTED TO REMOVED THE DISLODGED STENT THAT BECAME STUCK IN THE PROXIMAL LAD. THE ARTERY STARTED TO CLOT AFTER 30 MINUTES AND A VENTRI
Patient problems: Death; Thrombosis
MAUDE report 9474802 ↗InjurySep 30, 2019Migration; Migration
IT WAS REPORTED THAT STENT EXPLANTATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY. A 2.75X20MM PROMUS PREMIER DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. HOWEVER, THE STENT STUCK TO THE POST DILATATION BALLOON AND CAME OUT OF THE BODY AFTER DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH A NEW PROMUS STENT. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT'S STATUS WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9135453 ↗MalfunctionJun 11, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75X24MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED FOR USE. THE STENT WAS CRIMPED WHEN IT WAS TAKEN OUT OF STERILE PACKAGING/ HOOP. HOWEVER, IT WAS NOTED THAT THE STENT ARCHITECTURE WAS COMPROMISED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8689842 ↗MalfunctionJun 10, 2019Failure to Advance; Defective Device; Failure to Advance; Defective Device
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15MAY2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON AS BULGING AT THE ENDS OF THE STENT. A 3.00X16MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AFTER SEVERAL ATTEMPTS AND UPON INSPECTION, IT WAS NOTED THAT THE BALLOON WAS BULGING AT THE END OF THE STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8682864 ↗InjuryJun 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGMENT INSIDE PATIENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LEFT LEG. A 3.00X20MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF OF THE DELIVERY SYSTEM BEFORE IT WAS DEPLOYED. THE STENT HAD TO BE CRUSHED AGAINST THE WALL IN THE EXTERNAL ILIAC ARTERY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE AND ENDO-TRASHED IN THE ARTERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8677151 ↗MalfunctionApr 17, 2019Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. AFTER DEPLOYING A 4.00X20MM PROMUS PREMIER DRUG-ELUTING STENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM; HOWEVER, THE SHAFT BROKE APPROXIMATELY 100CM FROM THE HUB. THE DISTAL END OF THE DELIVERY SHAFT WAS STILL INSIDE THE GUIDE CATHETER AND THE REST OF THE DEVICE WAS OUTSIDE THE PATIENT'S BODY. THE PHYSICIAN WAS THEN ABLE TO REMOVE THE GUIDE CATHETER FROM THE PATIENT'S BODY AND RETRIEVED THE BROKEN PIECE. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8524703 ↗MalfunctionApr 10, 2019Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75X20MM PROMUS PREMIER DRUG-ELUTING STENT WAS USED IN A PROCEDURE. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS NOT HARMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8500893 ↗InjuryApr 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND HEAVY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 3.00X12MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON AND LODGED IN THE ARM WHICH WAS THEN RETRIEVED BY SNARING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8487155 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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