XIENCE SkypointRecalls & reported problems across all models
Abbott Vascular Inc. · 69 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,142
- Deaths reported
- 24
- Injuries reported
- 367
- Recalls
- 0
We found 69 models of XIENCE Skypoint by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 1,142 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2020 and Sep 29, 2026 — classified as 24 deaths, 367 injuries, 751 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (493 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 XIENCE Skypoint problems
Device problems
- Difficult to Remove493
- Failure to Advance479
- Device Dislodged or Dislocated221
- Adverse Event Without Identified Device or Use Problem183
- Difficult to Advance165
- Material Deformation128
- Material Rupture114
- Improper or Incorrect Procedure or Method106
Patient problems
- No Clinical Signs, Symptoms or Conditions827
- Thrombosis/Thrombus78
- Angina72
- Myocardial Infarction47
- Vascular Dissection39
- Foreign Body In Patient36
- Device Embedded In Tissue or Plaque27
- Cardiac Arrest26
XIENCE Skypoint models
69 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XIENCE Skypoint™ 1804350-28Coronary drug-eluting stent2 deaths52 reports
- XIENCE Skypoint™ 1804350-23Coronary drug-eluting stent2 deaths51 reports
- XIENCE Skypoint™ 1804350-38Coronary drug-eluting stent2 deaths50 reports
- XIENCE Skypoint™ 1804250-15Coronary drug-eluting stent40 reports
- XIENCE Skypoint™ 1804300-23Coronary drug-eluting stent1 death37 reports
- XIENCE Skypoint™ 1804300-18Coronary drug-eluting stent1 death36 reports
- XIENCE Skypoint™ 1804350-18Coronary drug-eluting stent1 death34 reports
- XIENCE Skypoint™ 1804300-28Coronary drug-eluting stent1 death33 reports
- XIENCE Skypoint™ 1804350-15Coronary drug-eluting stent1 death33 reports
- XIENCE Skypoint™ 1804250-23Coronary drug-eluting stent32 reports
- XIENCE Skypoint™ 1804250-18Coronary drug-eluting stent31 reports
- XIENCE Skypoint™ 1804225-15Coronary drug-eluting stent28 reports
- XIENCE Skypoint™ 1804300-15Coronary drug-eluting stent27 reports
- XIENCE Skypoint™ 1804350-12Coronary drug-eluting stent26 reports
- XIENCE Skypoint™ 1804400-18Coronary drug-eluting stent25 reports
- XIENCE Skypoint™ 1804400-23Coronary drug-eluting stent25 reports
- XIENCE Skypoint™ 1804225-12Coronary drug-eluting stent24 reports
- XIENCE Skypoint™ 1804250-33Coronary drug-eluting stent1 death24 reports
- XIENCE Skypoint™ 1804300-38Coronary drug-eluting stent24 reports
- XIENCE Skypoint™ 1804350-33Coronary drug-eluting stent24 reports
- XIENCE Skypoint™ 1804250-38Coronary drug-eluting stent23 reports
- XIENCE Skypoint™ 1804275-23Coronary drug-eluting stent22 reports
- XIENCE Skypoint™ 1804225-23Coronary drug-eluting stent21 reports
- XIENCE Skypoint™ 1804225-28Coronary drug-eluting stent20 reports
- XIENCE Skypoint™ 1804225-38Coronary drug-eluting stent20 reports
- XIENCE Skypoint™ 1804300-33Coronary drug-eluting stent1 death20 reports
- XIENCE Skypoint™ 1804400-12Coronary drug-eluting stent20 reports
- XIENCE Skypoint™ 1804250-48Coronary drug-eluting stent19 reports
- XIENCE Skypoint™ 1804250-12Coronary drug-eluting stent19 reports
- XIENCE Skypoint™ 1804225-18Coronary drug-eluting stent2 deaths17 reports
- XIENCE Skypoint™ 1804250-28Coronary drug-eluting stent1 death17 reports
- XIENCE Skypoint™ 1804275-18Coronary drug-eluting stent17 reports
- XIENCE Skypoint™ 1804300-12Coronary drug-eluting stent1 death17 reports
- XIENCE Skypoint™ 1804400-38Coronary drug-eluting stent16 reports
- XIENCE Skypoint™ 1804275-38Coronary drug-eluting stent15 reports
- XIENCE Skypoint™ 1804275-28Coronary drug-eluting stent14 reports
- XIENCE Skypoint™ 1804400-28Coronary drug-eluting stent1 death14 reports
- XIENCE Skypoint™ 1804225-33Coronary drug-eluting stent12 reports
- XIENCE Skypoint™ 1804275-15Coronary drug-eluting stent12 reports
- XIENCE Skypoint™ 1804400-15Coronary drug-eluting stent12 reports
- XIENCE Skypoint™ 1804350-48Coronary drug-eluting stent1 death11 reports
- XIENCE Skypoint™ 1804275-12Coronary drug-eluting stent11 reports
- XIENCE Skypoint™ 1804300-08Coronary drug-eluting stent10 reports
- XIENCE Skypoint™ 1804350-08Coronary drug-eluting stent10 reports
- XIENCE Skypoint™ 1804325-23Coronary drug-eluting stent1 death9 reports
- XIENCE Skypoint™ 1804400-33Coronary drug-eluting stent1 death9 reports
- XIENCE Skypoint™ 1804225-08Coronary drug-eluting stent8 reports
- XIENCE Skypoint™ 1804250-08Coronary drug-eluting stent1 death7 reports
- XIENCE Skypoint™ 1804325-28Coronary drug-eluting stent7 reports
- XIENCE Skypoint™ 1804300-48Coronary drug-eluting stent6 reports
- XIENCE Skypoint™ 1804275-33Coronary drug-eluting stent6 reports
- XIENCE Skypoint™ 1804325-18Coronary drug-eluting stent6 reports
- XIENCE Skypoint™ 1804325-38Coronary drug-eluting stent5 reports
- XIENCE Skypoint™ 1804450-18Coronary drug-eluting stent5 reports
- XIENCE Skypoint™ 1804325-15Coronary drug-eluting stent4 reports
- XIENCE Skypoint™ 1804400-08Coronary drug-eluting stent4 reports
- XIENCE Skypoint™ 1804450-23Coronary drug-eluting stent3 reports
- XIENCE Skypoint™ 1804500-15Coronary drug-eluting stent3 reports
- XIENCE Skypoint™ 1804275-48Coronary drug-eluting stent2 reports
- XIENCE Skypoint™ 1804325-12Coronary drug-eluting stent2 reports
- XIENCE Skypoint™ 1804450-33Coronary drug-eluting stent2 reports
- XIENCE Skypoint™ 1804500-28Coronary drug-eluting stent1 death2 reports
- XIENCE Skypoint™ 1804400-48Coronary drug-eluting stent1 report
- XIENCE Skypoint™ 1804325-08Coronary drug-eluting stent1 report
- XIENCE Skypoint™ 1804325-33Coronary drug-eluting stent1 report
- XIENCE Skypoint™ 1804450-15Coronary drug-eluting stent1 report
- XIENCE Skypoint™ 1804450-28Coronary drug-eluting stent1 report
- XIENCE Skypoint™ 1804500-12Coronary drug-eluting stent1 report
- XIENCE Skypoint™ 1804500-18Coronary drug-eluting stent1 death1 report
Recent XIENCE Skypoint adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936410 ↗InjurySep 29, 2026Device Dislodged or Dislocated
It was reported that the procedure was to treat the circumflex coronary artery. The 3.5x18 mm Xience Skypoint stent dislodged from the delivery system prior to reaching the target lesion. There was no resistance. The stent went down into the aorta and is undeployed. A snare was attempted but was unsuccessful. A non-Abbott stent was used to treat the target lesion and the patient was discharged as planned. No additional information was provided.
Patient problems: Foreign Body In Patient
MAUDE report 50935930 ↗InjuryAug 6, 2026Device Dislodged or Dislocated
It was reported that the procedure was to treat a lesion in the right coronary artery (RCA). A bend and calcium was located in the proximal anatomy and a dual guide wire technique was used for support; however, no resistance during advancement was reported. The 3.5x33mm Xience Skypoint stent delivery system (SDS) was attempted to be used in the procedure; however, the stent became dislodged. Therefore, the patient was transferred another hospital for bypass surgery of other vessels and removal of the stent. No additional information was provided.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 50161473 ↗DeathJul 28, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem
It was reported that the procedure was to treat a basilar artery. The lesion was pre-dilated with a 2.75 x 10mm Sapphire II PRO balloon. The 3.50 x 15mm Xience Skypoint drug-eluting stent was implanted when suspected hyper fusion syndrome occurred. Post dilatation was not performed, and it was noted that hemostasis was achieved with a ProStyle device. Subsequently, the patient was transferred to the intensive care unit for observation when left hand immobility, and right pupil dilation and right sided blindness were noted. A code blue was called, and it was determined that the patient was experiencing a right sided cerebral hemorrhage. The patient was stabilized and another code blue was called. Medication was provided and the patient transferred to another center for potential further intervention. Following the patient's transfer to another facility, no additional information from that facility is available. It was subsequently noted on (b)(6) 2026 that the patient died on (b)(6) 2026. No additional information was provided.
Patient problems: Dyskinesia; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Nervous System Injury; Visual Disturbances
MAUDE report 50060973 ↗MalfunctionJul 20, 2026Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25873308 ↗MalfunctionJul 9, 2026Difficult to Remove; Material Separation; Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25764564 ↗InjuryJul 6, 2026Break; Improper or Incorrect Procedure or Method; Defective Device; Material Deformation; Activation Failure; Noise, Audible; Migration; Failure to Deflate
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS MID-RIGHT CORONARY ARTERY LESION WITH 50% STENOSIS. A 3.5X38 MM XIENCE SKYPOINT DRUG-ELUDING STENT (DES) WAS ADVANCED TO THE TARGET LESION. HOWEVER, A SCRAPING/GRINDING SOUND WAS HEARD. THE STENT WAS REMOVED AND INSPECTED, BUT NO DAMAGE WAS NOTED. THE STENT WAS ADVANCED TO THE TARGET LESION AGAIN. DURING INFLATION AT 6 ATM, ONLY THE DISTAL PORTION OF THE BALLOON INFLATED DUE TO A CRACK IN THE SHAFT. THEREFORE, THE STENT WAS PARTIALLY DEPLOYED, AND THE BALLOON WAS UNABLE TO BE DEFLATED. THE DELIVERY SYSTEM WAS SLOWLY REMOVED AND THE STENT MOVED BACK TO THE PROXIMAL SECTION OF THE LESION. THE DELIVERY SYSTEM WAS REMOVED, BUT THE STENT REMAINED IN THE ANATOMY AND HAD SHORTENED TO 30 MM. A 4 MM BALLOON DILATION CATHETER WAS USED TO FULLY DEPLOY THE STENT. THE STENT WAS DEPLOYED IN PART OF THE LESION SITE AND A HEALTHY SEGMENT, AND THE STENT STRUTS APPEARED TO BE OVERLAPPED IN TWO LAYERS. A NEW 4X23 MM XIENCE DES WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 25722677 ↗MalfunctionJun 17, 2026Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY LESION. A 3.5X48 MM XIENCE SKYPOINT DRUG-ELUDING STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION. HOWEVER, IT FAILED TO CROSS THE LESION. A GUIDELINER WAS INSERTED AND THE DES WAS ADVANCED AGAIN. HOWEVER, IT AGAIN FAILED TO CROSS THE LESION. DURING REMOVAL, RESISTANCE WAS NOTED BETWEEN THE SDS AND GUIDLINER, CAUSING THE EDGES OF THE STENT TO BE MANGLED. BOTH DEVICES WERE REMOVED TOGETHER. A NEW 3.5X48 MM XIENCE SKYPOINT SDS AND GUIDELINER WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 25539582 ↗InjuryJun 5, 2026Device Damaged by Another Device
IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.50 X 33 MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS IMPLANTED. UPON REMOVAL OF AN UNSPECIFIED GUIDE WIRE IN A SECONDARY BRANCH, THE DES WAS EXPLANTED AND LOCATED IN THE PATIENT'S RIGHT BRACHIAL ARTERY. A 3.5 X 38 MM XIENCE DES WAS IMPLANTED IN THE LAD TO REPLACE THE EXPLANTED STENT. THE PATIENT WAS CURRENTLY ADMITTED AND HEPARINIZED OVERNIGHT. THE FOLLOWING DAY ((B)(6) 2026), THE PATIENT UNDERWENT A CUTDOWN AND THE 3.50 X 33 MM DES WAS SUCCESSFULLY REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410955 ↗MalfunctionJun 3, 2026Difficult to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION. THE 3.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED WHEN THE DEVICE HAD RESISTANCE WITH A NON-ABBOTT HEMOSTATIC ROTATING HEMOSTATIC VALVE (RHV) AND THE STENT CAME OFF INSIDE THE RHV. THE DISLODGED STENT WAS SIMPLY REMOVED FROM THE RHV AND ANOTHER XIENCE SKYPOINT 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 25376976 ↗MalfunctionJun 3, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY LESION WITH 90% STENOSIS. A NON-ABBOTT BDC WAS USED TO PRE-DILATE THE VESSEL WITHOUT ISSUE. THE 3.5X18 MM XIENCE SKYPOINT DRUG ELUDING STENT (DES) WAS PREPARED BEFORE PATIENT USE AS PER THE INSTRUCTIONS FOR USE WITHOUT ISSUE. SLIGHT RESISTANCE WAS NOTED WHILE CROSSING THE LESION. DURING THE FIRST INFLATION AT 6 ATM, THE BALLOON RUPTURED. THE DES WAS REMOVED WITH THE STENT STILL MOUNTED ON THE BALLOON. A NEW 3.5X23 MM XIENCE SKYPOINT DES WAS IMPLANTED WITHOUT ISSUE. TWO NON-ABBOTT BALLOON DILATION CATHETERS WERE USED FOR POST-DILATION WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS 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 25376975 ↗MalfunctionJun 1, 2026Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE 3.5X12 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THERE WAS RESISTANCE DURING REMOVAL AND THE STENT BECAME STRETCHED AND MANGLED. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351371 ↗MalfunctionMay 28, 2026Break; Failure to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X15MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE PATIENT HOWEVER FAILED TO CROSS THE LESION DUE TO THE ANATOMY. WHEN THE SDS WAS REMOVED FROM THE PATIENT IT WAS NOTED THE STENT HAD MOVED ON THE BALLOON AND THE STENT STRUTS WERE BROKEN AND LIFTED. 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 25315249 ↗MalfunctionMay 27, 2026Difficult to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 3.5X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED AND MET RESISTANCE WITH A GUIDE WIRE. A STRUT BECAME CAUGHT ON THE GUIDE WIRE AND THE STENT MOVED HALFWAY OFF THE DELIVERY SYSTEM. THE DELIVERY SYSTEM BALLOON WAS INFLATED IN ORDER TO KEEP THE STENT ABLE TO BE REMOVED WITH THE DELIVERY SYSTEM. A NEW 3.5X23 MM XIENCE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25306282 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE WAS ADMITTED WITH AN ST ELEVATION MYOCARDIAL INFARCTION (STEMI) INVOLVING THE CORONARY ARTERY OF THE ANTERIOR WALL. ONE XIENCE SKYPOINT (3.5 X 28 MM) STENT IMPLANTED. ON (B)(6) 2026, THE PATIENT WAS RE-ADMITTED WITH CHRONIC ISCHEMIC HEART DISEASE (A PRE-EXISTING CONDITION) AND OCCLUSION (STENOSIS) OF THE CORONARY ARTERY STENT. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY, (B)(6) 2026 TO A SHORT-TERM NURSING FACILITY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Obstruction/Occlusion
MAUDE report 25246472 ↗
Other Abbott Vascular Inc. products
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- Armada213 models · 1,904 reports
- Indeflator7 models · 1,196 reports · 9 recalls
- XIENCE Sierra56 models · 1,161 reports · 1 recall
- 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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