XIENCE Skypoint™ 1804225-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648233036), received between Jun 23, 2021 and Jan 23, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Difficult to Remove; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HIGHLY CALCIFIED LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY. A GUIDELINE WAS ADVANCED OVER THE BMW UNIVERSAL II GUIDE WIRE WHICH WAS PLACED IN THE CX. A 2.25X33MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED HOWEVER COULD NOT ADVANCE. WHEN PULLING BACK THE SDS, THE STENT BECAME STUCK AND FELT LIKE IT WAS GOING TO DISLODGE FROM THE BALLOON. THE WHOLE SYSTEM WAS REMOVED WITH FORCE WHEN IT WAS NOTED THE DISTAL PART OF THE GUIDE WIRE HAD SEPARATED. THE SEPARATED PORTION REMAINED IN THE DISTAL CX AS NO ATTEMPTS WERE MADE TO RETRIEVE THE WIRE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160570 ↗
• MalfunctionSep 2, 2025Leak/Splash; Activation Failure; Leak/Splash; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED CORONARY ARTERY. THE 2.25X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND PRESSURE WAS APPLIED; HOWEVER, THE DELIVERY SYSTEM BALLOON FAILED TO INFLATE AND THEREFORE, THE STENT FAILED TO DEPLOY. THE SDS WAS REMOVED FROM THE PATIENT. CONTRAST WAS NOTED TO BE LEAKING AFTER REMOVAL. A NON-ABBOTT STENT WAS USED TO CONTINUE THE PROCEDURE. 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 22939389 ↗
• MalfunctionApr 15, 2024Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.25X33 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, HOWEVER THE STENT BECAME CAUGHT ON THE DISTAL EDGE OF THE GUIDING CATHETER, THUS BECOMING DEFORMED AND MOVED ON THE BALLOON. THE SDS WITH THE STENT ATTACHED WAS REMOVED THROUGH THE FEMORAL SITE WITHOUT ISSUE. A NON-ABBOTT 2.25X32 MM STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT AFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106008 ↗
• MalfunctionNov 17, 2023Break; Break

  MEDWATCH RECEIVED WHICH STATES: XIENCE SKYPOINT (ABBOTT) 2.25X33MM CORONARY STENT STRUT BROKE INSIDE GUIDE CATHETER. STENT WAS REMOVED UNDEPLOYED. A NEW STENT WAS USED TO OPEN LESION WITH NO COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18163103 ↗
• MalfunctionNov 9, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH 90% STENOSIS, HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.25X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH RESISTANCE AND FAILED TO CROSS DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY UPON REMOVAL. THERE WERE NO OTHER DEVICE ISSUES NOTED. ANOTHER UNSPECIFIED DEVICE FAILED TO CROSS SO THE PROCEDURE WAS COMPLETED. ROTABLATION IS TO BE PERFORMED AT A LATER DATE 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 18101258 ↗
• InjuryJun 21, 2023Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE POSTERIOR DESCENDING ARTERY (PDA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. AFTER A CUTTING BALLOON WAS USED FOR PRE-DILATATION, THE 2.25X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE SDS BECAME STUCK WITH THE GUIDEWIRE DURING ADVANCEMENT. THEREFORE THE SDS WAS ATTEMPTED TO BE REMOVED FROM THE ANATOMY, DURING REMOVAL THE SDS ALSO MET WITH RESISTANCE AND HAD TO BE REMOVED WITH THE GUIDEWIRE AS A SINGLE UNIT WHEN THE STENT DISLODGED FROM THE DELIVERY SYSTEM. AN UNSUCCESSFUL ATTEMPT TO REMOVE THE DISLODGED STENT WAS MADE WITH SNARE DEVICE. AN ADDITIONAL STENT WAS ADVANCED TO EMBED THE DISLODGED STENT INTO THE TARGET LESION TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17175254 ↗
• MalfunctionApr 25, 2022Material Separation; Material Separation

  IT WAS REPORTED THE 2.25X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS USED IN A PROCEDURE AND SEPARATED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197866 ↗
• MalfunctionApr 1, 2022Difficult 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 LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON. THEN A 2.25 X 33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER THE STENT FAILED TO CROSS DUE TO ANATOMICAL CHALLENGES. THEREFORE, THE SDS WAS REMOVED AND RESISTANCE WAS NOTED DURING REMOVAL DUE TO ANATOMICAL CHALLENGES. A FLARED STENT STRUT WAS OBSERVED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SECOND DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON FOLLOWED BY DEPLOYMENT OF ANOTHER XIENCE SKYPOINT STENT TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13973047 ↗
• MalfunctionDec 18, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 99% STENOSED, HEAVILY CALCIFIED, HEAVILY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.25X33 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY AND THERE WAS RESISTANCE WITH THE ANATOMY DURING INDEPENDENT REMOVAL. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13040069 ↗
• MalfunctionNov 8, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. REPORTEDLY, A 2.25X33MM XIENCE SKYPOINT DRUG ELUTING STENTS (DES) WAS ATTEMPTED TO BE ADVANCED, BUT THE GUIDE CATHETER (GC) TIP WAS DAMAGED, AND THE DES COULD NOT REACH THE LESION. THE FIRST STENT WAS DIFFICULT TO REMOVE BECAUSE THE GUIDE CATHETER TIP WAS DAMAGED AND PREVENTED THE STENT FROM EASILY BEING RETRACTED. THE GC WAS REPLACED AND ANOTHER 2.5X33MM SKYPOINT DES WAS ADVANCED, HOWEVER THE VESSEL WAS TORTUOUS, AND THE GUIDE CATHETER HAD DIFFICULTY NAVIGATING THE TORTUOUS ANATOMY AND KEPT ¿POPPING OUT¿ OF THE LEFT CORONARY OSTIUM. THE DEPLOYER ALSO REALIZED THAT THE 2.5X33MM DES WAS THE INCORRECT SIZE. THE DES DID NOT REACH THE TARGET LESION. A 2.5X15MM WAS THEN ADVANCED BUT AGAIN, THE VESSEL WAS TORTUOUS, AND THE GUIDE CATHETER HAD DIFFICULTY NAVIGATING THE TORTUOUS ANATOMY AND COULD NOT ADVANCE TO THE LESION. IT WAS ALSO DETERMINED THAT THE LESION NEEDED MORE PREPARATION. A 3X28MM WAS THEN ATTEMPTED BUT THE VESSEL WAS TORTUOUS, AND THE GUIDE CATHETER HAD DIFFICULTY NAVIGATING THE TORTUOUS ANATOMY, AND THIS SIZE STENT DID NOT WORK AS WELL. THE DES COULD NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775923 ↗
• MalfunctionJul 14, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE HEAVILY TORTUOUS RIGHT CORONARY ARTERY. A 2.25X33MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE TORTUOUS ANATOMY. THE DES WAS REMOVED WITH RESISTANCE MET DUE TO THE ANATOMY AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 12170717 ↗
• MalfunctionJun 23, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MILDLY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH 75% STENOSIS. DURING ADVANCEMENT OF THE 2.25X33 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS), IT BECAME CAUGHT IN THE LESION AND THE STENT BECAME FRACTURED. THERE WAS NO RESISTANCE DURING REMOVAL AND A NON-ABBOTT STENT 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 12049617 ↗