XIENCE Skypoint™ 1804275-48Recalls & reported problems
Abbott Vascular Inc. · XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 2.75 mm x 48 mm / Rapid-Exchange · Class 3 · Implant
All models of XIENCE Skypoint (69)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648231278), received between Dec 11, 2024 and Mar 2, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Component Missing1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Component Missing
IT WAS REPORTED THAT DURING PREPARATION OF A 2.75X48 MM XIENCE SKYPOINT, IT WAS NOTED THAT THE STENT WAS MISSING FROM THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24490281 ↗MalfunctionDec 11, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT MILDLY TORTUOUS MID AND DISTAL CIRCUMFLEX ARTERIES OF THE LEFT CIRCUMFLEX CORONARY ARTERY. AFTER IMPLANTATION OF A 2.75X48MM XIENCE SKYPOINT DRUG-ELUTING STENT, THE STENT WAS NOTED TO BE EXPIRED. 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 20905742 ↗
Other Coronary drug-eluting stent devices
- SYNERGY™ H7493926038300Boston Scientific Corporation · Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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