MULTI-LINK VISION 1007848-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648050657), received between Nov 21, 2016 and Mar 2, 2021 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 2, 2021Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE LEFT TIBIAL ARTERY. A NON-ABBOTT GUIDE WIRE WAS ADVANCED INTO THE PATIENT ANATOMY AND OTHER DEVICES WERE ADVANCED OVER THE GUIDE WIRE WITHOUT ISSUE. THE 3.0 X 28 MM VISION STENT DELIVERY SYSTEM (SDS) WAS INSERTED ONTO THE GUIDE WIRE. DURING ADVANCEMENT ON THE GUIDE WIRE, THE PHYSICIAN NOTED THE GUIDE WIRE WAS GRITTY AND STICKY, AND RESISTANCE WAS NOTED ADVANCING THE SDS. THE DECISION WAS MADE TO REMOVE THE SDS. RESISTANCE WAS NOTED DURING REMOVAL AND THE TIP OF THE SDS SEPARATED. AS THE DEVICE HAD NOT ENTERED THE PATIENT ANATOMY, THE SDS AND THE SEPARATED TIP WERE EASILY REMOVED FROM THE GUIDE WIRE. THERE WAS NO ADVERSE PATIENT EFFECT. THE PHYSICIAN WIPED THE GUIDE WIRE. THE PROCEDURE WAS CONTINUED WITH IMPLANT OF TWO ADDITIONAL VISION STENTS USING THE SAME GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402198 ↗
• DeathMar 13, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2007 2 MULTI-LINK VISION STENTS WERE IMPLANTED WITHOUT REPORTED ISSUE. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A COUGH AND WAS ADMITTED. FIVE DAYS LATER, ON (B)(6) 2013, THE PATIENT DIED FROM CONGESTIVE HEART FAILURE. THERE WAS NO REPORTED RELATED ISSUE WITH THE STENT IMPLANTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Heart Failure

  MAUDE report 7336745 ↗
• InjuryJan 6, 2017Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  SUS VOLUNTARY EVENT REPORT WAS RECEIVED STATING THE FOLLOWING: REPORT #: MW5066282. ON (B)(6) 2016, A CARDIAC CATH WAS ATTEMPTED TO BE PERFORMED BY PHYSICIAN VIA THE RIGHT RADIAL ARTERY. INITIAL VISION STENT WAS UNABLE TO BE ADVANCED IN CORONARY; BECAME MANGLED AND UNABLE TO BE DRAWN BACK IN TO GUIDE CATHETER. WHEN TRYING TO REMOVE FROM BODY, STENT CAME OFF OF STENT BALLOON SYSTEM. MULTIPLE, VARIED ATTEMPTS TO REMOVE BUT UNSUCCESSFUL. STENT CRUSHED TO SIDE WALL OR RADIAL ARTERY. PATIENT REMAINED WITHOUT PAIN IN ARM DURING AND AFTER CATH. VASCULAR SURGERY WAS CONSULTED. NOTES STATES THAT AT THIS TIME THE RADIAL ARTERY APPEARS TO BE PATENT. ABBOTT MULTI-LINK VISION STENT DELIVERY SYSTEM SIZE: 3.0 X 28 MM REF# 1067848-28 LOT# 6032241, EXP DATE: 02/28/2019.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6228916 ↗
• InjuryNov 21, 2016Detachment Of Device Component; Retraction Problem; Failure to Advance; Material Twisted/Bent

  ON (B)(6) 2016, A CARDIAC CATH WAS ATTEMPTED TO BE PERFORMED BY PHYSICIAN VIA THE RIGHT RADIAL ARTERY. INITIAL VISION STENT WAS UNABLE TO BE ADVANCED IN CORONARY; BECAME MANGLED AND UNABLE TO BE DRAWN BACK IN TO GUIDE CATHETER. WHEN TRYING TO REMOVE FROM BODY, STENT CAME OFF OF STENT BALLOON SYSTEM. MULTIPLE, VARIED ATTEMPTS TO REMOVE BUT UNSUCCESSFUL. STENT CRUSHED TO SIDE WALL OR RADIAL ARTERY. PATIENT REMAINED WITHOUT PAIN IN ARM DURING AND AFTER CATH. VASCULAR SURGERY WAS CONSULTED. NOTES STATES THAT AT THIS TIME THE RADIAL ARTERY APPEARS TO BE PATENT. ABBOTT MULTI-LINK VISION STENT DELIVERY SYSTEM SIZE: 3.0 X 28MM REF # 1067848-28 LOT# 6032241, EXP DATE: 02/28/2019.

  Patient problems: Foreign Body In Patient

  MAUDE report 6124735 ↗