MULTI-LINK ULTRA 1003381-13Recalls & reported problems
Abbott Vascular Inc. · MULTI-LINK RX ULTRA Coronary Stent System 4.50 mm x 13 mm · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648035265), received between Jan 27, 2017 and Jan 27, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component1
- Device Dislodged or Dislocated1
- Failure to Advance1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2017Detachment Of Device Component; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE 4.5 X 13 MM ULTRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, WOULD NOT CROSS THE LESION. THE SDS WAS RETRACTED AND A 3.5 X 8 MM BALLOON CATHETER WAS THEN USED TO DILATE THE RCA. UPON EXAMINATION OF THE SDS IT WAS DETERMINED THAT THERE WAS NO DAMAGE TO THE 4.5 X 13 MM ULTRA SDS; THEREFORE, IT WAS REINSERTED; HOWEVER, AGAIN IT WOULD NOT CROSS THE LESION. UPON RETRACTION OF THE SDS A SECOND TIME IT WAS OBSERVED THAT THE STENT IMPLANT HAD DISLODGED AND REMAINED IN THE RCA. THERE WAS NO RESISTANCE FELT DURING REMOVAL OF THE SDS. AFTER NUMEROUS ATTEMPTS TO SNARE THE STENT FAILED, A 1.2 MM BALLOON CATHETER WAS INSERTED INTO THE STENT AND INFLATED ENOUGH TO GRAB THE STENT, WHICH THEN WAS ABLE TO BE BROUGHT DOWN ALMOST TO THE FEMORAL ARTERY INSERTION SITE. AT THIS TIME OPEN HEART SURGEONS WERE CALLED TO DO A GROIN EXPLORATION TO REMOVE THE STENT FROM THE BODY. THEY REMOVED THE STENT PIECE BY PIECE FROM THE PATIENT. THE PATIENT HAS RECOVERED WITH NO FURTHER COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6284931 ↗
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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