MULTI-LINK ULTRA 1003381-18Recalls & reported problems
Abbott Vascular Inc. · MULTI-LINK RX ULTRA Coronary Stent System 4.50 mm x 18 mm · Class 3 · Implant
Data updated Oct 16, 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 08717648035272), received between Jun 13, 2017 and Jul 17, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Dyspnea1
- No Patient Involvement1
- Respiratory Failure1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PRIOR TO USE, THE STENT OF A 4.5X18MM MULTILINK ULTRA STENT DELIVERY SYSTEM (SDS) WAS DISLODGED AND REMAINED IN THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. AN UNSPECIFIED STENT 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 Patient Involvement
MAUDE report 10292641 ↗InjuryJun 13, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A US RX ULTRA 9-CELL 4.5/18 MM STENT WAS IMPLANTED ON (B)(6) 2017 IN THE MID-CIRCUMFEX ARTERY AFTER THROMBECTOMY AND POST-DILATED WITH A 4.5 NON-COMPLIANT BALLOON REDUCING 100% STENOSIS TO 0 WITH TIMI 3 FLOW. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2017 WITH SHORTNESS OF BREATH AND RESPIRATORY FAILURE. TREATMENT INCLUDED A VENTILATOR AND DIURESIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2017 BACK TO THE NURSING HOME WHERE HE RESIDES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Dyspnea; Respiratory Failure
MAUDE report 6638937 ↗
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
- PALMAZ Balloon Expandable Stent P308Cordis US Corp. · STENT, CORONARY7 reports
- Cobra PzF 170-03-35024Celonova Biosciences, 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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