XIENCE SierraRecalls & reported problems across all models
Abbott Vascular Inc. · 56 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,161
- Deaths reported
- 57
- Injuries reported
- 775
- Recalls
- 1
We found 56 models of XIENCE Sierra by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 1,161 adverse event reports in the FDA's MAUDE database, received between Jun 1, 2018 and Oct 15, 2024 — classified as 57 deaths, 775 injuries, 329 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (169 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
XIENCE Sierra recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 25, 2020Terminated
Incorrect expiration date
Z-2370-2020 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗
Most reported XIENCE Sierra problems
Device problems
- Adverse Event Without Identified Device or Use Problem656
- Difficult to Remove169
- Failure to Advance169
- Device Dislodged or Dislocated148
- Improper or Incorrect Procedure or Method102
- Material Deformation78
- Difficult to Advance51
- Material Rupture43
Patient problems
- No Consequences Or Impact To Patient270
- Angina250
- Thrombosis117
- Stenosis113
- Myocardial Infarction109
- No Clinical Signs, Symptoms or Conditions83
- No Code Available77
- No Patient Involvement47
XIENCE Sierra models
56 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XIENCE Sierra™ 1550350-33Coronary drug-eluting stent1 recall32 reports
- XIENCE Sierra™ 1550300-38Coronary drug-eluting stent7 deaths48 reports
- XIENCE Sierra™ 1550300-23Coronary drug-eluting stent3 deaths45 reports
- XIENCE Sierra™ 1550350-18Coronary drug-eluting stent1 death45 reports
- XIENCE Sierra™ 1550350-38Coronary drug-eluting stent2 deaths43 reports
- XIENCE Sierra™ 1550250-15Coronary drug-eluting stent3 deaths42 reports
- XIENCE Sierra™ 1550350-28Coronary drug-eluting stent4 deaths39 reports
- XIENCE Sierra™ 1550250-18Coronary drug-eluting stent2 deaths38 reports
- XIENCE Sierra™ 1550300-15Coronary drug-eluting stent38 reports
- XIENCE Sierra™ 1550300-18Coronary drug-eluting stent1 death38 reports
- XIENCE Sierra™ 1550250-38Coronary drug-eluting stent2 deaths36 reports
- XIENCE Sierra™ 1550350-23Coronary drug-eluting stent1 death34 reports
- XIENCE Sierra™ 1550300-28Coronary drug-eluting stent3 deaths33 reports
- XIENCE Sierra™ 1550250-12Coronary drug-eluting stent3 deaths32 reports
- XIENCE Sierra™ 1550275-15Coronary drug-eluting stent1 death29 reports
- XIENCE Sierra™ 1550350-15Coronary drug-eluting stent1 death29 reports
- XIENCE Sierra™ 1550225-18Coronary drug-eluting stent2 deaths24 reports
- XIENCE Sierra™ 1550250-28Coronary drug-eluting stent2 deaths24 reports
- XIENCE Sierra™ 1550350-12Coronary drug-eluting stent1 death23 reports
- XIENCE Sierra™ 1550225-15Coronary drug-eluting stent1 death22 reports
- XIENCE Sierra™ 1550225-38Coronary drug-eluting stent1 death22 reports
- XIENCE Sierra™ 1550250-23Coronary drug-eluting stent22 reports
- XIENCE Sierra™ 1550250-33Coronary drug-eluting stent3 deaths22 reports
- XIENCE Sierra™ 1550300-12Coronary drug-eluting stent22 reports
- XIENCE Sierra™ 1550275-23Coronary drug-eluting stent1 death21 reports
- XIENCE Sierra™ 1550400-23Coronary drug-eluting stent3 deaths21 reports
- XIENCE Sierra™ 1550225-12Coronary drug-eluting stent2 deaths19 reports
- XIENCE Sierra™ 1550275-18Coronary drug-eluting stent19 reports
- XIENCE Sierra™ 1550400-18Coronary drug-eluting stent19 reports
- XIENCE Sierra™ 1550400-38Coronary drug-eluting stent17 reports
- XIENCE Sierra™ 1550400-12Coronary drug-eluting stent1 death16 reports
- XIENCE Sierra™ 1550225-23Coronary drug-eluting stent15 reports
- XIENCE Sierra™ 1550275-12Coronary drug-eluting stent1 death15 reports
- XIENCE Sierra™ 1550300-33Coronary drug-eluting stent15 reports
- XIENCE Sierra™ 1550400-15Coronary drug-eluting stent15 reports
- XIENCE Sierra™ 1550325-23Coronary drug-eluting stent1 death14 reports
- XIENCE Sierra™ 1550275-28Coronary drug-eluting stent1 death13 reports
- XIENCE Sierra™ 1550275-38Coronary drug-eluting stent13 reports
- XIENCE Sierra™ 1550400-28Coronary drug-eluting stent13 reports
- XIENCE Sierra™ 1550225-28Coronary drug-eluting stent12 reports
- XIENCE Sierra™ 1550275-33Coronary drug-eluting stent1 death12 reports
- XIENCE Sierra™ 1550250-08Coronary drug-eluting stent11 reports
- XIENCE Sierra™ 1550325-15Coronary drug-eluting stent11 reports
- XIENCE Sierra™ 1550300-08Coronary drug-eluting stent10 reports
- XIENCE Sierra™ 1550325-12Coronary drug-eluting stent1 death10 reports
- XIENCE Sierra™ 1550325-18Coronary drug-eluting stent10 reports
- XIENCE Sierra™ 1550225-08Coronary drug-eluting stent9 reports
- XIENCE Sierra™ 1550350-08Coronary drug-eluting stent1 death9 reports
- XIENCE Sierra™ 1550325-28Coronary drug-eluting stent8 reports
- XIENCE Sierra™ 1550325-33Coronary drug-eluting stent7 reports
- XIENCE Sierra™ 1550325-38Coronary drug-eluting stent7 reports
- XIENCE Sierra™ 1550400-08Coronary drug-eluting stent6 reports
- XIENCE Sierra™ 1550225-33Coronary drug-eluting stent3 reports
- XIENCE Sierra™ 1550275-08Coronary drug-eluting stent3 reports
- XIENCE Sierra™ 1550325-08Coronary drug-eluting stent3 reports
- XIENCE Sierra™ 1550400-33Coronary drug-eluting stent3 reports
Recent XIENCE Sierra adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2024Improper or Incorrect Procedure or Method; Failure to Advance; Improper or Incorrect Procedure or Method; Failure to Advance
IT WAS REPORTED THE 2.75X18MM RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) AND THE 4.0X12MM RX XIENCE SIERRA SDS BOTH FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS NOTED THE 4.0X12 RX XIENCE SIERRA WAS USED PAST THE EXPIRATION DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450834 ↗MalfunctionMay 3, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 2.5X33MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS INSERTED INTO A 5FRENCH (F) GUIDE EXTENSION CATHETER WITH RESISTANCE WHEN THE STENT DISLODGED AND WAS UNABLE TO BE USED. THE DISLODGED STENT WAS REMOVED FROM INSIDE THE GUIDE EXTENSION CATHETER. ANOTHER 2.5X28MM XIENCE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19243290 ↗MalfunctionApr 8, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THAT THE STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19061029 ↗MalfunctionMar 15, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY CALCIFIED AND NON TORTUOUS. REPORTEDLY, THE XIENCE SIERRA DES 2.50X28 RX STENT DELIVERY SYSTEM WAS ADVANCED OVER A NON-ABBOTT PRESSURE WIRE AND IT FROZE ON THE WIRE. IT WAS REMOVED WITH RESISTANCE AS A UNIT WITHOUT ISSUE. THE LESION WAS RE-WIRED WITH A DIFFERENT WIRE AND A NEW XIENCE WAS SUCCESSFULLY DEPLOYED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18914630 ↗MalfunctionMar 15, 2024Stretched; Failure to Advance; Device Dislodged or Dislocated; Stretched; Failure to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. REPORTEDLY, THE XIENCE SIERRA DES 2.75X23 RX STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH ANOTHER NON-ABBOTT STENT DURING CROSSING. THE STENT DISLODGED; HOWEVER, WAS RETRIEVED WITH THE SDS BALLOON WHICH WAS STILL IN THE ANATOMY. THE STENT WAS REMOVED ELONGATED WITH THE SDS BALLOON. THE LESION WAS DILATED AND A DIFFERENT STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18914557 ↗MalfunctionMar 8, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X12MM XIENCE SIERRA STENT DELIVERY SYSTEM WAS USED FOR POST-DILATATION AT 14 ATMOSPHERES. IT WAS DILATATED FOR A SECOND TIME AND WHEN REMOVING FROM THE ANATOMY IT BECAME STUCK. THEREFORE, IT WAS DILATATED AGAIN TO 10 ATMOSPHERES AND THEN WAITED FOR 15 SECONDS FOR DEFLATION. THE DELIVERY BALLOON WAS REMOVED WITH HEAVY RESISTANCE NOTED. THE XIENCE SIERRA WAS DETAINED [DEPLOYED]. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18867936 ↗InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HYPOGLYCEMIC EVENT AND CHEST PAINS. THE PROCEDURE WAS TO TREAT A RESTENOSIS IN AN UNSPECIFIED ARTERY. THE 3.5X18MM XIENCE SIERRA STENT WAS IMPLANTED ON (B)(6) 2020, HOWEVER, THE PATIENT WENT BACK TO THE HOSPITAL ON (B)(6) 2023 DUE TO THE STENT BEING BLOCKED BY SCAR TISSUE. IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY (DAPT) AFTER THE PROCEDURE. ANGIOGRAPHY WAS PERFORMED TO CONFIRM RESTENOSIS. A BALLOON WAS USED TO OPEN UP THE IMPLANTED STENT. THE PATIENT WAS DISCHARGED. THERE WAS NO ADVERSE PATIENT SEQUELAE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Stenosis
MAUDE report 17218138 ↗InjuryApr 28, 2023Difficult or Delayed Positioning; Migration; Difficult or Delayed Positioning; Migration
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) AND THE OSTIAL RCA WITHOUT CALCIFICATION OR TORTUOSITY. TWO XIENCE SIERRA STENTS, 2.25X23MM AND 3.5X12MM, WERE ADVANCED WITHOUT RESISTANCE AND IMPLANTED. HOWEVER, THE DISTAL END OF THE 3.5X12MM XIENCE SIERRA STENT DEPLOYED IN THE OSTIAL RCA WAS HARD TO VISUALIZE DURING CONTRAST INJECTIONS AND THE STENT PLACEMENT WAS A GEOGRAPHICAL MISS. THE DISTAL END OF THE STENT WAS BARELY ATTACHED TO THE VESSEL WALL AND ONCE THE STENT DELIVERY SYSTEM AND GUIDE WIRE WERE REMOVED WITHOUT RESISTANCE, THE STENT DISLODGED. SINCE THE STENT CANNOT BE VISUALIZED, THE DISLODGED STENT WAS UNABLE TO BE RETRIEVED AND NO ATTEMPTS WERE MADE. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16834917 ↗MalfunctionJan 16, 2023Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 4.00X28MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. THEREFORE THE SDS WAS REMOVED WITH DIFFICULTY ALSO DUE TO THE ANATOMY AND THE STENT STRUT WAS NOTED TO BE FLARED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16174187 ↗InjuryJan 10, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT ID: (B)(6). IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2019, TREATING A TARGET LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.0 X 33 MM XIENCE SIERRA STENT AND A 3.0 X 28 MM XIENCE SIERRA STENT WERE IMPLANTED. ON (B)(6) 2019, THE PATIENT PRESENTED WITH CHEST PAIN, SHORTNESS OF BREATH AND NAUSEA. ELECTROCARDIOGRAM WAS PERFORMED, CONFIRMING ST ELEVATION MYOCARDIAL INFARCTION. ANGIOGRAPHY REVEALED THAT THE 3.0 X 28 MM XIENCE SIERRA STENT WAS UNDER-DEPLOYED AND IN-STENT RESTENOSIS WAS NOTED. MEDICATIONS WERE ADMINISTERED. A REVASCULARIZATION PROCEDURE WAS PERFORMED AND THE EVENT RESOLVED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina; Dyspnea; Myocardial Infarction; Nausea; Stenosis; Thrombosis/Thrombus
MAUDE report 16134576 ↗InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT ID: (B)(6). IT WAS REPORTED THAT A 2.5X23 MM XIENCE SIERRA STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY ON (B)(6) 2020. THE PATIENT EXPERIENCED ANGINA ON (B)(6) 2021. ON (B)(6) 2022, DURING A FOLLOW UP, 75% STENOSIS WAS NOTED IN THE PROXIMAL LAD; HOWEVER, NO IN-STENT RESTENOSIS WAS NOTED IN THE XIENCE SIERRA STENT IN THE MID LAD. ON (B)(6) 2022, ELECTIVE INTERVENTION WAS PERFORMED TO TREAT THE PROXIMAL LAD AND A 3.0X23 MM XIENCE SKYPOINT STENT WAS IMPLANTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY. ACCORDING TO THE PHYSICIAN¿S OPINION, THE EVENT IS NOT RELATED TO THE STUDY AS IT IS A TREATMENT FOR DE NOVO LESION OCCURRING IN THE NATURAL HISTORY; HOWEVER, IT IS UNKNOWN IF THE RESTENOSIS WAS +/- 5 MM FROM THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina; Stenosis
MAUDE report 15789269 ↗InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT ID: (B)(6). IT WAS REPORTED THROUGH THE TACTICS REGISTRY THAT A 4X23MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2020. DUAL ANTIPLATELET TREATMENT WAS GIVEN AFTER STENT IMPLANTATION ON (B)(6) 2021 THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND 100% STENOSIS WAS NOTED PROXIMAL TO THE XIENCE SIERRA STENT. A NON-ABBOTT STENT WAS IMPLANTED FROM THE NEW LESION OVERLAPPING INTO THE IMPLANTED XIENCE SIERRA STENT, AND A DRUG COATED BALLOON WAS USED AS WELL. ON (B)(6) 2021, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. IT IS THE PHYSICIAN¿S OPINION THAT THE EVENT WAS NOT RELATED TO THE STUDY AS IT WAS PROGRESSION OF DISEASE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Myocardial Infarction; Stenosis
MAUDE report 15765117 ↗InjuryJul 8, 2022Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.5X33MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION AND INFLATED ONE TIME BELOW NOMINAL PRESSURE WHEN A RUPTURE OCCURRED. THE STENT WAS NOT FULLY APPOSED TO THE VESSEL WALL AND REQUIRED ADDITIONAL DILATATION TO BE FULLY IMPLANTED, THEREFORE ANOTHER 3.5MM BALLOON WAS USED TO POST-DILATE THE STENT AND SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS COMMENTED THAT THE CALCIFIED PART IN THE LESION OR A STENT THAT HAD ALREADY BEEN DEPLOYED AT THE PROXIMAL PART TO THE LESION, PROBABLY CAUSED THE RUPTURE, BUT THAT IT CANNOT BE CONCLUDED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14958186 ↗DeathJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PROCEDURE IN A LESION IN AN UNKNOWN ARTERY. AT AN UNSPECIFIED TIME AFTER STENT IMPLANTATION OF A XIENCE STENT THE PATIENT DIED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Angina; Cardiac Arrest; Insufficient Information; Myocardial Infarction
MAUDE report 14838293 ↗InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. POST STENT IMPLANTATION OF A XIENCE STENT, WORSENING HEART FAILURE WAS NOTED. THIS WAS RESOLVED IN AN UNSPECIFIED MANNER. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Heart Failure/Congestive Heart Failure; No Clinical Signs, Symptoms or Conditions
MAUDE report 14838255 ↗
Other Abbott Vascular Inc. products
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- NC TREK56 models · 1,842 reports · 12 recalls
- Armada213 models · 1,904 reports
- Indeflator7 models · 1,196 reports · 9 recalls
- XIENCE Skypoint69 models · 1,142 reports
- Graftmaster15 models · 1,071 reports
- TREK50 models · 909 reports
- XIENCE ALPINE72 models · 898 reports
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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