MULTI-LINK MINI VISION 1007823-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648049538), received between May 17, 2017 and Dec 13, 2022 — classified as 4 injuries.

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2022Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  USER FACILITY MEDWATCH REPORT (MW5113174) RECEIVED STATING: VOLUNTARY REPORT. UNABLE TO DELIVER THE STENT TO THE LESION. STENT EMBOLIZED TO THE RT. FEMORAL ARTERY DURING REMOVAL OF THE STENT. RADIOLOGIST INTO REVIEW THE CINE IMAGES SURGEON INTO CONSULT FOR STENT REMOVAL FROM FEMORAL ARTERY SITE. PT. TRANSFERRED TO OPERATING ROOM FOR REMOVAL OF THE STENT , STABLE, WIFE AND SON INFORMED OF THE SITUATION BY PHYSICIAN. ABBOT BARE METAL MINI VISION RX; 535 GTIN: (B)(4). FDA SAFETY REPORT ID# (B)(4). ADDITIONAL INFORMATION RECEIVED FROM THE SITE: THE STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY AND COULD NOT BE ADVANCED PAST THE LEFT POSTERIOR DESCENDING ARTERY (LPDA)/DISTAL CIRCUMFLEX (CX) ORIGIN OF THE MAIN CX. WHEN DRAWN BACK, THE DEVICE DID NOT GO INTO THE GUIDE CATHETER. THE PROXIMAL END OF THE STENT SEEMED FLARED AND THE PHYSICIAN DID NOT WANT TO RISK DISLODGEMENT. HOWEVER, THE STENT DISLODGED AND EMBOLIZED TO THE RIGHT FEMORAL ARTERY. VASCULAR SURGERY WAS CONSULTED AND THE PATIENT HAD FEMORAL ENDARTERECTOMY. THERE WAS NO ADVERSE PATIENT SEQUELA.

  Patient problems: Embolism/Embolus

  MAUDE report 15970801 ↗
• InjuryNov 8, 2022Migration or Expulsion of Device; Failure to Deliver

  UNABLE TO DELIVER THE STENT TO THE LESION. STENT EMBOLIZED TO THE RT. FEMORAL ARTERY DURING REMOVAL OF THE STENT. RADIOLOGIST INTO REVIEW THE CINE IMAGES SURGEON INTO CONSULT FOR STENT REMOVAL FROM FEMORAL ARTERY SITE. PT. TRANSFERRED TO OPERATING ROOM FOR REMOVAL OF THE STENT , STABLE, WIFE AND SON INFORMED OF THE SITUATION BY PHYSICIAN. ABBOT BARE METAL MINI VISION RX; 535 GTIN: (B)(4). FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760433 ↗
• InjuryJun 4, 2018Detachment Of Device Component; Kinked; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.5X23 MM MINI VISION STENT DELIVERY SYSTEM (SDS) WAS INSERTED THROUGH THE TUOHY WHEN A SMALL KINK WAS NOTED ON THE SHAFT OF THE SDS. THE PROCEDURE CONTINUED AND THE SDS WAS INFLATED TO 12 ATMOSPHERES OF PRESSURE IN THE LAD, BUT THE DEVICE DID NOT HOLD PRESSURE. THE SDS WAS REMOVED, BUT ONLY THE PROXIMAL 1/3 CAME OUT. THE DISTAL 2/3 OF THE SDS CATHETER HAD SEPARATED IN THE PATIENT, BUT WAS SUCCESSFULLY REMOVED WITH A SNARE. IT IS SUSPECTED THAT THE KINK NOTED EARLIER BECAME FURTHER COMPROMISED AND WAS THE POINT OF THE CATHETER SEPARATION IN THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7567463 ↗
• InjuryMay 17, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2012, THREE MULTI-LINK VISION STENTS WERE IMPLANTED. TWO STENTS (3.0X18MM, 3.5X18MM) WERE IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA) AND A 2.5X23MM STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE PATIENT HAD NOT HAD HIS NEW MEDICATIONS FILLED YET, WHEN EIGHT DAYS AFTER THE STENT PROCEDURE, ON (B)(6) 2012, THE PATIENT HAD A MYOCARDIAL INFARCTION WITH CHEST PAIN WHEN PUTTING UP DRY WALL. THE LAD WAS 100% OCCLUDED WITH THROMBUS AND THERE WAS MODERATE DISEASE IN THE RCA, BUT THE RCA STENTS WERE PATENT. THERE WAS ALSO 80% OCCLUSION IN THE OBTUSE MARGINAL ARTERY (OM) AND 70% OCCLUSION IN THE POSTERIOR DESCENDING CORONARY ARTERY (PDA). CORONARY ARTERY BYPASS GRAFT WAS PERFORMED IN THE LAD, OMS, AND PDA. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis

  MAUDE report 6573479 ↗