MULTI-LINK ULTRA 1003382-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648035302), received between Dec 16, 2016 and Oct 20, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH NO CALCIFICATION AND NO TORTUOSITY IN LEFT MAIN CORONARY ARTERY. THE 5.0 X 13 MM RX ULTRA 9-CELL STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITH NO ISSUES; HOWEVER, DURING AN ATTEMPT TO DEPLOY THE STENT, THE STENT DID NOT DEPLOY. THE SDS WAS REMOVED WITHOUT ISSUE. A NEW SDS WAS USED IN THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10707589 ↗
• InjuryFeb 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 5.0X13MM RX ULTRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE 6FR GUIDING CATHETER HOWEVER THE PHYSICIAN DECIDED TO EXCHANGE THE GUIDING CATHETER FOR A 7FR. THE SDS WAS RETRACTED HOWEVER THE STENT DISLODGED WHEN ENTERING THE GUIDING CATHETER AND EMOBOLIZED TO THE AORTA. ATTEMPTS WERE MADE TO SNARE THE STENT HOWEVER WERE UNSUCCESSFUL, THE PATIENT WAS STABLE AND THEN SENT FOR A CT SCAN TO FURTHER ASSESS THE SITUATION. THE PATIENT WAS THEN BROUGHT BACK TO THE CATH LAB AND THE STENT WAS ABLE TO BE SNARED AND REMOVED FROM THE PATIENT. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9659928 ↗
• InjuryFeb 21, 2018Difficult or Delayed Positioning

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH NO TORTUOSITY AND NO CALCIFICATION IN THE RIGHT CORONARY ARTERY (RCA). DURING DEPLOYMENT OF THE 5.0 X 13 MM ULTRA STENT; THE DISTAL PORTION OF THE STENT DID NOT FULLY DEPLOY. MULTIPLE NON-COMPLIANT BALLOONS WERE USED TO FULLY OPEN THE DISTAL END OF THE STENT SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287199 ↗
• InjuryFeb 21, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 60% - 70% STENOSED AND HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH 3.0X20MM AND 3.5X15MM TREK BALLOON DILATATION CATHETERS. A 5.0X13MM ULTRA RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. THE SDS WAS BEING REMOVED WITHOUT RESISTANCE WHEN THE STENT DISLODGED. A CINE CONFIRMED THE STENT WAS FLOATING IN THE FEMORAL ARTERY OF THE LEG. AN ATTEMPT TO RETRIEVE THE STENT WITH THE DELIVERY SYSTEM WAS MADE BUT IT WAS UNSUCCESSFUL. THE STENT WAS LEFT IN FREE FLOATING DOWNWARD. THE PATIENT IS REPORTED TO BE OK AND THERE WAS A 30% FLOW IMPROVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6346718 ↗
• InjuryDec 16, 2016Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT MAIN. A 5.0X13MM ULTRA STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION; HOWEVER, IT FAILED TO CROSS DUE TO THE ANATOMY. THE DEVICE WAS WITHDRAWN; HOWEVER, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM UPON REMOVAL OF THE DEVICE FROM THE PATIENTS ANATOMY. A BALLOON CATHETER WAS USED TO DEPLOY THE STENT IN HEALTHY TISSUE. A 4.5X12MM NON-ABBOTT STENT WAS SUCCESSFULLY DEPLOYED PROXIMAL TO THE ULTRA STENT SLIGHTLY OVERLAPPING THE STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6183562 ↗