MULTI-LINK VISIONRecalls & reported problems across all models

We found 19 models of MULTI-LINK VISION by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2016 and Oct 11, 2023 — classified as 3 deaths, 7 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MULTI-LINK VISION problems

MULTI-LINK VISION models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MULTI-LINK VISION 1007850-15

  STENT, CORONARY
  7 reports
• MULTI-LINK VISION 1007848-18

  STENT, CORONARY
  4 reports
• MULTI-LINK VISION 1007848-28

  STENT, CORONARY
  1 death4 reports
• MULTI-LINK VISION 1007849-15

  STENT, CORONARY
  1 death4 reports
• MULTI-LINK VISION 1007849-23

  STENT, CORONARY
  3 reports
• MULTI-LINK VISION 1007850-12

  STENT, CORONARY
  3 reports
• MULTI-LINK VISION 1007847-18

  STENT, CORONARY
  2 reports
• MULTI-LINK VISION 1007848-12

  STENT, CORONARY
  2 reports
• MULTI-LINK VISION 1007849-12

  STENT, CORONARY
  2 reports
• MULTI-LINK VISION 1007849-18

  STENT, CORONARY
  2 reports
• MULTI-LINK VISION 1007849-28

  STENT, CORONARY
  2 reports
• MULTI-LINK VISION 1007850-18

  STENT, CORONARY
  2 reports
• MULTI-LINK VISION 1007847-12

  STENT, CORONARY
  1 report
• MULTI-LINK VISION 1007847-15

  STENT, CORONARY
  1 report
• MULTI-LINK VISION 1007847-23

  STENT, CORONARY
  1 death1 report
• MULTI-LINK VISION 1007847-28

  STENT, CORONARY
  1 report
• MULTI-LINK VISION 1007849-08

  STENT, CORONARY
  1 report
• MULTI-LINK VISION 1007850-08

  STENT, CORONARY
  1 report
• MULTI-LINK VISION 1007850-28

  STENT, CORONARY
  1 report

Recent MULTI-LINK VISION adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2023Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS LEFT VERTEBRAL ARTERY THAT WAS NOTED TO HAVE IN-STENT RESTENOSIS. THE 3.5X18MM VISION STENT FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS FELT WITH THE UNSPECIFIED CATHETER DURING REMOVAL. THE DEVICES HAD TO BE REMOVED AS A SINGLE UNIT. UPON REMOVAL, THE STENT STRUT WAS OBSERVED TO BE FLARED. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913287 ↗
• InjuryJul 26, 2022Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. THE 3.0X18MM RX VISION CORONARY STENT SYSTEM WAS INSERTED BUT FAILED TO CROSS THE LESION. THEREFORE, THE DEVICE WAS REMOVED AND AGAIN INSERTED. THE DEVICE STILL FAILED TO CROSS THE LESION AND WAS REMOVED. PRIOR TO INSERTING THE DEVICE A THIRD TIME, IT WAS OBSERVED THE STENT WAS NO LONGER ON THE CATHETER. IT IS UNKNOWN IF THE STENT CAME OFF WHILE IN THE ANATOMY. ULTRASOUND WAS PERFORMED BUT THE STENT WAS UNABLE TO BE OBSERVED ANYWHERE IN THE ANATOMY. HOWEVER, THE MISSING STENT COULD ALSO NOT BE FOUND OUTSIDE THE ANATOMY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15103404 ↗
• MalfunctionJul 20, 2021Difficult to Remove; No Apparent Adverse Event; Difficult to Remove; No Apparent Adverse Event

  A 3.00X12MM RX VISION BALLOON-EXPANDABLE STENT SYSTEM (BESS) WAS RETURNED IN A BIO BAG WITHOUT ANY INFORMATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE ANALYSIS IDENTIFIED THAT A BMW UNIVERSAL GUIDE WIRE WAS RETURNED FROZEN IN THE BESS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12198976 ↗
• MalfunctionApr 2, 2021Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. A 3.5X12MM RX VISION STENT WAS PREPPED AND THEN INSERTED INTO THE PATIENT. ONCE AT THE TARGET LESION, THE BALLOON WAS INFLATED AND IT WAS NOTED THERE WAS NO STENT ON THE BALLOON. THE ENTIRE CATH LAB SEARCHED BUT COULD NOT FIND THE STENT. A SCAN WAS PERFORMED OF THE PATIENT AND THE STENT WAS NOT FOUND INSIDE THE PATIENT. IT IS ASSUMED IT DISLODGED DURING PREPARATION AS THE STENT WAS NOT FOUND IN THE BODY. ANOTHER SAME SIZE STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609453 ↗
• MalfunctionMar 22, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE 3.5X23 MM VISION STENT WAS NOT IN THE BOX. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT. TWO 3.0X23 MM VISION STENTS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11544532 ↗
• 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 ↗
• MalfunctionDec 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING PREPARATION OF A 3.50X28MM RX VISION BALLOON EXPANDABLE STENT THE STENT CAME OFF WHEN THE STYLET WAS REMOVED. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10983962 ↗
• MalfunctionSep 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD). DURING ADVANCEMENT OF THE RX VISION STENT DELIVERY SYSTEM (SDS), THE STENT DISLODGED PRIOR TO ENTERING THE TUOHY VALVE; HOWEVER, THIS WAS NOT NOTED UNTIL AFTER THE BALLOON WAS INFLATED AT THE LESION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER RX VISION WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10589731 ↗
• InjurySep 22, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT CORONARY CIRCUMFLEX (LCX). BEFORE THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD PREVIOUSLY UNDERGONE A PROCEDURE IN THE SAME REGION. A 3.50 X 08 MM RX VISION STENT DELIVERY SYSTEM (SDS) WAS PREPPED PER THE INSTRUCTIONS FOR USE AND THE STENT WAS CONFIRMED TO BE ON THE BALLOON PRIOR TO INSERTING THE SDS INTO THE PATIENT ANATOMY. THE SDS WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE SDS FAILED TO CROSS THE LESION. THE SDS WAS REMOVED AND IT WAS NOTED THAT THE STENT WAS DISLODGED FROM THE BALLOON. THE STENT COULD NOT BE SEEN THROUGH ECHOCARDIOGRAPHY; THEREFORE, A NEW 3.0 X 08MM UNSPECIFIED STENT WAS USED AND SUCCESSFULLY IMPLANTED TO THE TARGET LESION. THEN, AN UNSPECIFIED BALLOON WAS INSERTED AND INFLATED AND DRAGGED UP THE GUIDE WIRE IN AN ATTEMPT TO RETRIEVE THE DISLODGED STENT; HOWEVER, THE STENT WAS NOT RETRIEVED. A CT SCAN WAS PERFORMED BUT THE STENT COULD NOT BE SEEN IN THE ANATOMY. THE PROCEDURE ENDED AT THIS POINT. NO ADDITIONAL TREATMENT WAS PERFORMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10567751 ↗
• MalfunctionMar 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, A 4.0X15MM RX VISION WAS SUCCESSFULLY REMOVED FROM THE HOOP COIL; HOWEVER, WHEN THE PROTECTIVE SHEATH WAS REMOVED FROM THE BALLOON, THE STENT DISLODGED AND REMAINED INSIDE THE SHEATH. THERE WAS NO DIFFICULTY REMOVING THE SHEATH AND THE DEVICE WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9897613 ↗
• MalfunctionFeb 6, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, RESISTANCE WAS MET DURING REMOVAL OF THE PROTECTIVE SHEATH AND ONCE REMOVED, IT WAS NOTED THAT THE STENT WAS DISLODGED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER VISION STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9679431 ↗
• MalfunctionOct 28, 2019Difficult 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 LESION IN THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. THEN A 2.75 X 18 MM VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCING OVER THE GUIDE WIRE; HOWEVER, RESISTANCE MET WITH THE GUIDE WIRE. THEREFORE, THE SDS RETRACTED BACK WITH RESISTANCE WHEN THE TIP BECAME SEPARATED OUTSIDE THE PATIENT¿S ANATOMY. THE DETACHED TIP AND THE REMAINDER OF THE SDS WAS REMOVED FROM THE GUIDE WIRE. ANOTHER 2.75 X 18 MM VISION SDS WAS ADVANCED WITH THE SAME GUIDE WIRE. THE TARGET LESION WAS SUCCESSFULLY TREATED. THERE WERE NO 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 9246792 ↗
• MalfunctionAug 19, 2019Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.00 X 18 MM RX VISION STENT WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY POST EXPIRATION DATE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8908656 ↗
• MalfunctionAug 2, 2019Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION WHEN PULLING THE STYLET FROM THE END OF THE 4.0 X 15 RX VISION STENT DELIVERY SYSTEM, SLIGHT RESISTANCE WAS MET AND THE STENT BECAME DISLODGED, STILL REMAINING ON THE STYLET. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. AFTERWARDS THE PHYSICIAN MANIPULATED AND INFLATED THE DEVICE ON THE TABLE FOR TROUBLESHOOTING PURPOSES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8857678 ↗
• MalfunctionFeb 7, 2019Inflation Problem; Difficult to Advance; Inflation Problem; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED WITH A CUTTING BALLOON CATHETER AND A GUIDELINER WAS USED. A 4.0 X 12 MM VISION STENT DELIVERY SYSTEM WAS USED AND MET INITIAL RESISTANCE WITH THE ANATOMY. THE STENT DELIVERY BALLOON WAS INFLATED TO A NOMINAL PRESSURE OF 9 ATMOSPHERES AND DEFLATED WITHOUT ANY ISSUES. HOWEVER, THE STENT WAS STILL ON THE BALLOON WHEN THE DEVICE WAS REMOVED FROM THE ANATOMY. THERE WAS A WAIST IN THE STENT DELIVERY BALLOON. THEREFORE, A 4.0 X 18 MM VISION STENT WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO 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 8317650 ↗

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