MULTI-LINK ULTRA 1003382-38Recalls & reported problems
Abbott Vascular Inc. · MULTI-LINK RX ULTRA Coronary Stent System 5.00 mm x 38 mm · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648035333), received between Jul 14, 2017 and Sep 12, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Expiration Issue” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Expiration Issue1
- Improper or Incorrect Procedure or Method1
Patient problems
- Dyspnea1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2018 DURING WHICH A 3.5 X 15 MM XIENCE ALPINE STENT AND A 5.0 X 38 MM ULTRA MULTI-LINK STENT WERE IMPLANTED FOR TREATMENT OF AN UNSPECIFIED VESSEL. THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2018 FOR SHORTNESS OF BREATH. UNSPECIFIED TREATMENT WAS ADMINISTERED TO THE PATIENT. FINAL PATIENT OUTCOME IS REPORTEDLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Dyspnea
MAUDE report 7870852 ↗MalfunctionJul 14, 2017Device Expiration Issue; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THIS WAS AN EMERGENT PROCEDURE TO TREAT A LESION LOCATED IN THE MID RIGHT CORONARY ARTERY. DUE TO THE DIAMETER OF THE VESSEL A LARGER STENT WAS REQUIRED; THEREFORE, THE 5.0 X 38 MM ULTRA STENT DELIVERY SYSTEM WAS SELECTED FOR USE. PRIOR TO USE THE STENT DELIVERY SYSTEM PACKAGING WAS CHECKED AND IT WAS OBSERVED THAT THE DEVICE HAD PAST ITS EXPIRATION DATE; HOWEVER, THE DECISION WAS MADE TO USE IT AS THIS WAS THE ONLY ONE THEY HAD IN STOCK AND IT WAS AN EMERGENCY PROCEDURE. THE PHYSICIAN WAS FULLY AWARE THAT THE DEVICE HAD EXPIRED. THE PATIENT IS FINE POST-PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6715541 ↗
Other STENT, CORONARY devices
- WALLSTENT® Endoprosthesis H965403130Boston Scientific Corporation · STENT, CORONARY35 reports
- WALLSTENT® Endoprosthesis H965402130Boston Scientific Corporation · STENT, CORONARY23 reports
- Tryton Side Branch Stent T5-2530-191-USTryton Medical, Inc. · Stent, Coronary1 death22 reports
- WALLSTENT® Endoprosthesis H965403330Boston Scientific Corporation · STENT, CORONARY21 reports
- WALLSTENT® Endoprosthesis H965403320Boston Scientific Corporation · STENT, CORONARY10 reports
- WALLSTENT® Endoprosthesis H965403120Boston Scientific Corporation · STENT, CORONARY9 reports
- Tryton Side Branch Stent T5-3035-151-USTryton Medical, Inc. · Stent, Coronary2 deaths7 reports
- MULTI-LINK VISION 1007850-15Abbott Vascular Inc. · STENT, CORONARY7 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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