XIENCE XPEDITIONRecalls & reported problems across all models
Abbott Vascular Inc. · 41 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 86
- Deaths reported
- 11
- Injuries reported
- 43
- Recalls
- 0
We found 41 models of XIENCE XPEDITION by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 86 adverse event reports in the FDA's MAUDE database, received between Aug 5, 2016 and May 2, 2023 — classified as 11 deaths, 43 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 XIENCE XPEDITION problems
Device problems
- Adverse Event Without Identified Device or Use Problem46
- Improper or Incorrect Procedure or Method14
- Difficult to Remove12
- Device Dislodged or Dislocated10
- Material Separation8
- Failure to Advance4
- Material Deformation4
- Device Expiration Issue3
Patient problems
- Stenosis28
- No Consequences Or Impact To Patient25
- Angina13
- No Patient Involvement9
- Death8
- Myocardial Infarction7
- Thrombosis6
- Cardiac Arrest5
XIENCE XPEDITION models
41 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XIENCE XPEDITION 1074350-38Coronary drug-eluting stent8 reports
- XIENCE XPEDITION 1074225-28Coronary drug-eluting stent1 death7 reports
- XIENCE XPEDITION 1074250-38Coronary drug-eluting stent1 death5 reports
- XIENCE XPEDITION 1074300-23Coronary drug-eluting stent5 reports
- XIENCE XPEDITION 1074300-38Coronary drug-eluting stent1 death5 reports
- XIENCE XPEDITION 1074225-18Coronary drug-eluting stent4 reports
- XIENCE XPEDITION 1074300-15Coronary drug-eluting stent3 reports
- XIENCE XPEDITION 1074350-18Coronary drug-eluting stent1 death3 reports
- XIENCE XPEDITION 1074350-23Coronary drug-eluting stent3 reports
- XIENCE XPEDITION 1074225-08Coronary drug-eluting stent2 reports
- XIENCE XPEDITION 1074250-15Coronary drug-eluting stent2 reports
- XIENCE XPEDITION 1074250-18Coronary drug-eluting stent2 reports
- XIENCE XPEDITION 1074250-23Coronary drug-eluting stent2 reports
- XIENCE XPEDITION 1074300-18Coronary drug-eluting stent2 reports
- XIENCE XPEDITION 1074300-33Coronary drug-eluting stent1 death2 reports
- XIENCE XPEDITION 1074325-18Coronary drug-eluting stent2 reports
- XIENCE XPEDITION 1074350-12Coronary drug-eluting stent1 death2 reports
- XIENCE XPEDITION 1074350-28Coronary drug-eluting stent2 reports
- XIENCE XPEDITION 1074350-33Coronary drug-eluting stent2 reports
- XIENCE XPEDITION 1074400-18Coronary drug-eluting stent1 death2 reports
- XIENCE XPEDITION 1074225-12Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074225-15Coronary drug-eluting stent1 death1 report
- XIENCE XPEDITION 1074225-23Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074250-08Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074250-12Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074250-33Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074275-18Coronary drug-eluting stent1 death1 report
- XIENCE XPEDITION 1074275-28Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074275-33Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074275-38Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074300-08Coronary drug-eluting stent1 death1 report
- XIENCE XPEDITION 1074300-12Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074300-28Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074325-33Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074325-38Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074350-08Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074350-15Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074400-15Coronary drug-eluting stent1 death1 report
- XIENCE XPEDITION 1074400-23Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074400-33Coronary drug-eluting stent1 report
- XIENCE XPEDITION 1074400-38Coronary drug-eluting stent1 report
Recent XIENCE XPEDITION adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 2, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 3.0X33MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED ON (B)(6) 2014. AN ALLERGIC REACTION OCCURRED AS THE PATIENT NOTICED SHORTNESS OF BREATH BUT HAD NO OTHER ADVERSE REACTIONS. THE PATIENT THOUGHT THIS IS SOMEWHAT NORMAL AS THE PATIENT IS ALLERGIC TO THINGS LIKE NICKEL, LATEX, BEES, STITCHES, AND AMONG OTHER THINGS. TREATMENT, IF ANY, WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Dyspnea; Hypersensitivity/Allergic reaction
MAUDE report 16853440 ↗InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PROC-124212/CN-150010: CAPTURING THE 2.5X23MM XIENCE XPEDITION STENT: IT WAS REPORTED THAT ON 11/8/2021, A 2.5X23MM XIENCE XPEDITION STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT CIRCUMFLEX ARTERY (LCX). ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED. MEDICATIONS WERE CHANGED AND REVASCULARIZATION WAS PERFORMED IN THE LCX USING A DRUG COATED BALLOON (DCB). THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina; Stenosis
MAUDE report 16285103 ↗InjurySep 19, 2022Material Separation; Material Separation
IT WAS REPORTED THAT "THE XIENCE XPEDITION [3.50 X 38 MM] SDS WAS REMOVED AND THE SHAFT WAS SEPARATED. THE PATIENT HAS TO HAVE SURGERY REQUIRED TO HAVE THE REST OF THE DEVICE REMOVED." NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 15451200 ↗MalfunctionMay 26, 2021Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress
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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11886777 ↗InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, A 3.25 X 33 MM XIENCE XPEDITION STENT WAS SUCCESSFULLY IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT WAS DISCHARGED TO HOME THE FOLLOWING DAY. ON(B)(6) 2021, THE PATIENT WAS RE-HOSPITALIZED WITH HEART FAILURE AND A MYOCARDIAL INFARCTION. A CORONARY ANGIOGRAM WAS PERFORMED AND SHOWED 70-80% STENOSIS IN THE LEFT MAIN CORONARY ARTERY AND 70% STENOSIS IN THE PROXIMAL LAD, PROXIMAL TO THE TARGET LESION. ON (B)(6) 2021, REVASCULARIZATION WAS PERFORMED, WITH IMPLANT OF A 3.5 X 18 MM XIENCE STENT IN THE LEFT MAIN AND LAD ARTERIES. THE EVENT RESOLVED ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Heart Failure; Myocardial Infarction; Stenosis
MAUDE report 11227524 ↗InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS WITH A CHRONIC, TOTAL OCCLUSION (100%) WITHIN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) LESION. PRE-DILATATION WAS PERFORMED. THREE 3.0X38MM XIENCE XPEDITION STENTS WERE IMPLANTED AND A 3.0X18MM XIENCE XPEDITION STENT WAS IMPLANTED WITHOUT A DEVICE ISSUE REPORTED. TIMI FLOW 3 AND 0% RESIDUAL STENOSIS WAS OBSERVED. PLAQUE SHIFT HAD OCCURRED WITHIN A XIENCE STENT AND THE SIDE BRANCH WAS LOST. THE SIDE BRANCH WAS ATTEMPTED TO BE RE-CROSSED UNSUCCESSFULLY. THE PATIENT HAD GONE INTO VENTRICULAR FIBRILLATION, TREATED WITH CARDIOVERSION. DURING OCT IMAGING, THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENTS RHYTHM RETURNED TO NORMAL SINUS AND THE EVENT RESOLVED. ELEVATED CARDIAC ENZYMES WERE ALSO OBSERVED WITHOUT ANY TREATMENT REPORTED AND WITHOUT ANY NEW MYOCARDIAL INFARCTION (MI) DIAGNOSED. REPORTEDLY, THE ELEVATED ENZYMES WERE LIKELY DUE TO CARDIAC ARREST ALONG WITH LOSS OF A SIDE BRANCH. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.
Patient problems: Cardiac Arrest; Cardiac Enzyme Elevation; Occlusion; Prolapse; Ventricular Fibrillation
MAUDE report 10656302 ↗MalfunctionSep 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A 3.5 X 08 MM XIENCE XPEDITION STENT DISLODGED DURING THE REMOVAL OF THE PROTECTIVE SHEATH. THERE WAS NO RESISTANCE WHILE REMOVING THE STYLET OR PROTECTIVE SHEATH. THE STENT DELIVERY SYSTEM (SDS) WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER XIENCE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10547584 ↗MalfunctionAug 19, 2020Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated
SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE STENT REMAINED STUCK IN THE PROTECTIVE SHEATH AND CAME OFF OF THE BALLOON.
Patient problems: No Patient Involvement
MAUDE report 10427968 ↗MalfunctionAug 5, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE 4.0X38 MM XIENCE XPEDITION STENT CAME OUT WHEN THE PROTECTIVE SHEATH AND STYLET WERE REMOVED WITH SOME RESISTANCE NOTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND THERE WAS NO REPORTED DEVICE USE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 10368063 ↗DeathApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A RECENT NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). NO PRE-DILATATION WAS PERFORMED. A 2.75X33MM AND 2.75X18MM XIENCE STENT WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD), CORONARY ARTERY LESION. A 2.75X18 AND A 2.75X8MM XIENCE STENT WERE IMPLANTED IN THE DIAGONAL CORONARY ARTERY, 80% STENOSED LESION. REPORTEDLY, STENT PLACEMENTS ANGIOGRAPHIC APPEARANCE WAS ACCEPTABLE AND POST-DILATATION WAS PERFORMED. THE END RESULT WAS TIMI FLOW 3 AND 0% DIAMETER STENOSIS. POST-PROCEDURE, THE PATIENT'S TROPONIN INCREASED AND A NEW MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED. THE PATIENT HAD AN INTRACRANIAL BLEED WITH HERNIATION WORSENED BY MEDICAL THERAPY FOR MI AND HAD BECOME UNRESPONSIVE. ON (B)(6) 2020, THE PATIENT EXPIRED. PER PHYSICIAN, THE EVENT WAS UNRELATED TO THE DEVICE AND UNRELATED TO THE PROCEDURE. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.
Patient problems: Death; Intracranial Hemorrhage; Myocardial Infarction; Neurological Deficit/Dysfunction
MAUDE report 9917838 ↗InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBSEQUENT TO THE INITIAL 30 DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE STENT THROMBOSIS, WITH ASSOCIATED ADVERSE EFFECTS OF MYOCARDIAL INFARCTION AND VENTRICULAR FIBRILLATION, RESOLVED ON (B)(6) 2020; HOWEVER, THE PATIENT WAS LEFT WITH COGNITIVE COMMUNICATION DIFFICULTIES, AS WELL AS PHYSICAL DECONDITIONING. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Cardiac Arrest; Embolism; Myocardial Infarction; Prolapse; Thrombosis; Ventricular Fibrillation
MAUDE report 9861612 ↗MalfunctionMar 11, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THE SHAFT OF A 3.0X38MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) SNAPPED DURING ADVANCEMENT OVER AN UNSPECIFIED GUIDE WIRE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9820954 ↗DeathFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE 2.5X30 MM TREK DILATATION CATHETER WAS INFLATED THREE TIMES IN THE CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. IT WAS INFLATED AT 14 ATMOSPHERES (ATMS), 20 ATMS AND 18 ATMS WHEN THE TREK RUPTURED. DURING REMOVAL OF THE TREK, THE BALLOON SEPARATED AND REMAINED IN THE ARTERY. ATTEMPTS MADE TO REMOVE/SNARE OUT THE SEPARATED SEGMENT OF THE TREK WERE NOT SUCCESSFUL. A VESSEL PERFORATION OCCURRED IN THE MID LAD DURING USE OF A NON-ABBOTT DILATATION CATHETER, BUT THE PATIENT REMAINED STABLE. THE 2.5X38 MM XIENCE XPEDITION STENT WAS DEPLOYED AT 12 ATMS FOR 15 SEC, THEN 12 ATM FOR 22 SEC, THEN 20 ATM FOR 15 SEC, AND 5 ATM FOR 11 SEC IN THE MID LAD OVER THE SEPARATED TREK BALLOON; HOWEVER, THE STENT DELIVERY SYSTEM (SDS) DID NOT FULLY DEFLATE AND WAS DIFFICULT TO REMOVE FROM THE GUIDE CATHETER, SO THE SDS AND GUIDE CATHETER WERE REMOVED TOGETHER AS A UNIT. THE PATIENT REMAINED STABLE. A 3.5X38 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PROXIMAL LAD AND A 4.0X12 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE OSTIAL LEFT MAIN CORONARY ARTERY. A 4.0 X 18 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PREDILATED LEFT MAIN TO LEFT CIRCUMFLEX. AFTER P
Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Occlusion
MAUDE report 9707781 ↗MalfunctionFeb 13, 2020Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE 2.5X30 MM TREK DILATATION CATHETER WAS INFLATED THREE TIMES IN THE CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. IT WAS INFLATED AT 14 ATMOSPHERES (ATMS), 20 ATMS AND 18 ATMS WHEN THE TREK RUPTURED. DURING REMOVAL OF THE TREK, THE BALLOON SEPARATED AND REMAINED IN THE ARTERY. ATTEMPTS MADE TO REMOVE/SNARE OUT THE SEPARATED SEGMENT OF THE TREK WERE NOT SUCCESSFUL. A VESSEL PERFORATION OCCURRED IN THE MID LAD DURING USE OF A NON-ABBOTT DILATATION CATHETER, BUT THE PATIENT REMAINED STABLE. THE 2.5X38 MM XIENCE XPEDITION STENT WAS DEPLOYED AT 12 ATMS FOR 15 SEC, THEN 12 ATM FOR 22 SEC, THEN 20 ATM FOR 15 SEC, AND 5 ATM FOR 11 SEC IN THE MID LAD OVER THE SEPARATED TREK BALLOON; HOWEVER, THE STENT DELIVERY SYSTEM (SDS) DID NOT FULLY DEFLATE AND WAS DIFFICULT TO REMOVE FROM THE GUIDE CATHETER, SO THE SDS AND GUIDE CATHETER WERE REMOVED TOGETHER AS A UNIT. THE PATIENT REMAINED STABLE. A 3.5X38 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PROXIMAL LAD AND A 4.0X12 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE OSTIAL LEFT MAIN CORONARY ARTERY. A 4.0 X 18 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PREDILATED LEFT MAIN TO LEFT CIRCUMFLEX. AFTER P
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9707663 ↗InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) /2019, THE PATIENT PRESENTED WITH ELEVATED CARDIAC ENZYMES AND A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. PRE-DILATATION WAS PERFORMED ON THE PROXIMAL RIGHT CORONARY ARTERY (RCA), 100% STENOSED LESION AND A 3.5X23MM (1074350-23 9053141) XIENCE XPEDITION STENT WAS SUCCESSFULLY IMPLANTED. PRE-DILATATION WAS ALSO PERFORMED ON THE MID CIRCUMFLEX (CX) CORONARY ARTERY, 100% STENOSED LESION AND A 2.5X28MM (1074250-28 9031141) XIENCE XPEDITION STENT WAS SUCCESSFULLY IMPLANTED. REPORTEDLY EXCELLENT RESULTS WERE OBSERVED WITH 0% DIAMETER STENOSIS, TIMI FLOW III, AND NO COMPLICATIONS. POST-PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN, CARDIAC ENZYMES REMAINED ELEVATED AND A NEW MYOCARDIAL INFARCTION WAS DIAGNOSED. MEDICATION WAS PROVIDED AS TREATMENT. PER PHYSICIAN, THE EVENT WAS UNKNOWN IF DEVICE RELATED. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL TREATMENT WAS PROVIDED. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.
Patient problems: Angina; Myocardial Infarction
MAUDE report 9655788 ↗
Other Abbott Vascular Inc. products
- MITRACLIP8 models · 5,973 reports · 2 recalls
- NC TREK56 models · 1,842 reports · 12 recalls
- Armada213 models · 1,904 reports
- Indeflator7 models · 1,196 reports · 9 recalls
- XIENCE Sierra56 models · 1,161 reports · 1 recall
- XIENCE Skypoint69 models · 1,142 reports
- Graftmaster15 models · 1,071 reports
- TREK50 models · 909 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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