MULTI-LINK ULTRA 1003382-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648035326), received between Apr 18, 2017 and Nov 19, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING REMOVAL OF THE PROTECTIVE SHEATH, WITHOUT RESISTANCE, THE 5.0X28 MM ULTRA STENT DISLODGED INSIDE THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED. A SAME SIZE ULTRA STENT DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8087009 ↗
• InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED VIA VOLUNTARY MEDWATCH REPORT (MW5076123): REPORTER STATED SHE HAD A HEART ATTACK IN 2016. SHE STARTED OFF WITH A CARDIO REHAB AND INSTEAD OF FEELING BETTER, FELT WORST. SHE HAD SHORTNESS OF BREATH AND WENT TO THE HOSPITAL. AFTER CARDIAC MONITORING, THE DRS DISCOVERED THAT THE STENT WAS 100% BLOCKED. REPORTER CONTINUES TO EXPERIENCE SYMPTOMS OF A HEART ATTACK IN AN ATTEMPT TO CLEAR THE STENT, THE BALLOON BLOCKED IN THE CORONARY ARTERY. THE DRS PUSHED THE BALLOON TO THE TIP OF ARTERY AND PUT A STENT ON EACH SIDE OF THE ARTERY TO HOLD IT IN PLACE. SHE WAS ADMINISTERED EFFIENT TO PREVENT BLOOD CLOTS. REPORTER IS WORRIED AND AFRAID TO TRAVEL OUT OF OR DO ANYTHING FOR FEAR OF DISLOCATING THE DEVICE. REPORTER STATES THAT THE MANUFACTURER (MFR) REFUSES TO TAKE RESPONSIBILITY REGARDING THIS FAULTY DEVICE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: IN (B)(6) 2016, THE PATIENT EXPERIENCED A HEART ATTACK AND AN ULTRA STENT WAS IMPLANTED. ON (B)(6) 2016, THE PATIENT EXPERIENCED ANGINA AND SHORTNESS OF BREATH AND WAS HOSPITALIZED. ANGIOGRAPHY REVEALED 100% STENT RESTENOSIS AND PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED (SEE MEDWATCH #2024168-2016-05135).

  Patient problems: Angina; Dyspnea; Stenosis

  MAUDE report 7469512 ↗
• InjuryApr 18, 2017Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY. THE US RX ULTRA 9-CELL 5.0/28MM STENT WAS SUCCESSFULLY DEPLOYED BUT THE BALLOON WOULD NOT DEFLATE. THE BALLOON HAD TO BE BURST AND THEN REMOVED FROM THE ANATOMY. THERE WAS NO DIFFICULTY DURING REMOVAL OF THE PROTECTIVE SHEATH AND THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6501886 ↗