MULTI-LINK MINI VISIONRecalls & reported problems across all models

We found 16 models of MULTI-LINK MINI VISION by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2016 and Dec 13, 2022 — classified as 16 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 MINI VISION problems

MULTI-LINK MINI VISION models

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

• MULTI-LINK MINI VISION 1007823-15

  STENT, CORONARY
  5 reports
• MULTI-LINK MINI VISION 1007821-08

  STENT, CORONARY
  4 reports
• MULTI-LINK MINI VISION 1007823-12

  STENT, CORONARY
  4 reports
• MULTI-LINK MINI VISION 1007823-23

  STENT, CORONARY
  4 reports
• MULTI-LINK MINI VISION 1007821-23

  STENT, CORONARY
  3 reports
• MULTI-LINK MINI VISION 1007822-15

  STENT, CORONARY
  2 reports
• MULTI-LINK MINI VISION 1007821-12

  STENT, CORONARY
  1 report
• MULTI-LINK MINI VISION 1007821-15

  STENT, CORONARY
  1 report
• MULTI-LINK MINI VISION 1007821-18

  STENT, CORONARY
  1 report
• MULTI-LINK MINI VISION 1007821-28

  STENT, CORONARY
  1 report
• MULTI-LINK MINI VISION 1007822-08

  STENT, CORONARY
  1 report
• MULTI-LINK MINI VISION 1007822-12

  STENT, CORONARY
  1 report
• MULTI-LINK MINI VISION 1007822-18

  STENT, CORONARY
  1 report
• MULTI-LINK MINI VISION 1007823-18

  STENT, CORONARY
  1 report
• MULTI-LINK MINI VISION 1007823-28

  STENT, CORONARY
  1 report
• MULTI-LINK MINI VISION 1010152-23

  STENT, CORONARY
  1 report

Recent MULTI-LINK MINI VISION adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMar 26, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX ARTERY THAT WAS MILDLY CALCIFIED AND TORTUOUS. AFTER A FAILED ATTEMPT TO CROSS WITH THE MINI VISION, WHEN THE DELIVERY SYSTEM WAS WITHDRAWN AND ON THE TABLE, THE STENT CAME OFF THE BALLOON. ANOTHER MINI VISION WAS USED TO COMPLETE THE PROCEDURE. 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 9885714 ↗
• InjuryAug 23, 2019Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. A 2.0 X 08 MM MINI VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER FAILED TO CROSS THE LESION DUE TO THE PATIENT ANATOMY. ON REMOVAL OF THE SDS WITHOUT REPORTED FORCE, RESISTANCE WITH THE LESION WAS MET AND THE STENT DISLODGED. MEDICAL INTERVENTION WAS PERFORMED TO REMOVE THE STENT AND A DISSECTION WAS NOTED. AN ADDITIONAL UNSPECIFIED STENT WAS USED TO TREAT THE DISSECTION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 8927751 ↗
• MalfunctionJul 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT BEFORE USE, THE STENT OF A 2.0 X 23 MM MINI VISION STENT DELIVERY SYSTEM WAS FOUND DISLODGED INSIDE THE PROTECTIVE SHEATH. ANOTHER 2.0 X 23 MM MINI VISION STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8827479 ↗
• InjuryApr 22, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 2.0X12MM MINI VISION STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY AND THE STENT DISLODGED. A NEW 2.0X8MM MINI VISION SDS WAS USED TO CRUSH THE DISLODGED STENT AGAINST THE WALL AND 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: Vessel Or Plaque, Device Embedded In

  MAUDE report 8537818 ↗
• MalfunctionMar 6, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. AN UNSPECIFIED TURNTRAC GUIDE WIRE (GW) WAS INSERTED AND POSITIONED INTO THE ANATOMY. A 2.0X18MM MINI VISION STENT DELIVERY SYSTEM WAS BACKLOADED ON THE GW AND WHEN ADVANCING (STILL OUTSIDE OF THE ANATOMY) RESISTANCE WAS MET AND THE STENT-BALLOON AREA GOT STUCK ON THE GW. PHYSICIAN ATTEMPTED TO ADVANCE AND WITHDRAW BUT WAS UNABLE TO DO SO. IT WAS THEN NOTED THAT THE STENT-BALLOON AREA HAD A PIECE PROTRUDING WHICH MADE THE PHYSICIAN THINK IT WAS NOT FULLY FLUSHED. THE GUIDE WIRE WAS THEN PULLED WITH MUCH FORCE AS RESISTANCE WAS MET WITH THE ANATOMY AND REMOVED ALTOGETHER AS A SINGLE UNIT ALONG WITH THE SDS. THE PROTRUDING AREA IN THE STENT-BALLOON RETURNED TO ITS NORMAL STATE ONCE TAKEN OFF THE GW. BALLOON ANGIOPLASTY WAS PERFORMED 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 8396034 ↗
• MalfunctionJan 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC MID CIRCUMFLEX ARTERY THAT DID NOT HAVE ANY TORTUOSITY AND WAS 100% STENOSED. BEFORE USE, A 2.25 X 15 MM MINI VISION STENT DISLODGED FROM THE STENT DELIVERY BALLOON WHEN THE STYLET WAS REMOVED. THEREFORE, A 2.25 X 18 MM MINI VISION STENT WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8281603 ↗
• MalfunctionJan 22, 2019Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE MID TO DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE TARGET LESION WAS PRE-DILATED WITH AN UNSPECIFIED DEVICE. THE 2.5X12MM MINI VISION RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH ANATOMICAL RESISTANCE, AND THE BDC SHAFT KINKED AND SUBSEQUENTLY BROKE INTO TWO SEPARATE PIECES ON THE PORTION JUST INSIDE THE GUIDING CATHETER. THE ENTIRE BDC WAS WITHDRAWN FROM THE PATIENT ANATOMY AS A SINGLE UNIT WITH THE GUIDING CATHETER AND GUIDE WIRE, AND IT WAS CONFIRMED THAT NO BDC DEVICE COMPONENTS REMAINED IN THE PATIENT ANATOMY. ANOTHER MINI VISION BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS, AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8268787 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE HAD A MYOCARDIAL INFARCTION IN THE RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2013. FOUR VISION STENTS WERE IMPLANTED EMERGENTLY AT (B)(6) HOSPITAL, (B)(6) BY DR. (B)(6). A MINI VISION RX 2.25 X 8 MM AND A VISION RX 2.75 X 15 MM WERE IMPLANTED IN THE MID RCA, A MINI VISION RX 2.5 X 15 MM WAS IMPLANTED IN THE PROXIMAL RCA, AND A MINI VISION RX 2.5 X 12 MM WAS IMPLANTED IN THE DISTAL RCA. FOUR YEARS LATER, THE PATIENT WAS RE-ADMITTED ON (B)(6) 2017 WITH LIGHTHEADEDNESS, DIZZINESS, ANGINA AND ANOTHER MYOCARDIAL INFARCTION. THE PATIENT STATED HE WAS TOLD THAT ALL FOUR OF THE PREVIOUSLY PLACED STENTS WERE 100% BLOCKED; ALTHOUGH HE WAS NOT TOLD WHETHER THIS WAS DUE TO THROMBOSIS OR RE-STENOSIS. TWO ADDITIONAL UNKNOWN STENTS WERE EMERGENTLY IMPLANTED AS TREATMENT AT FLORIDA HOSPITAL BY DR. MASSARO. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Myocardial Infarction; Occlusion

  MAUDE report 7843593 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE HAD A MYOCARDIAL INFARCTION IN THE RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2013. FOUR VISION STENTS WERE IMPLANTED EMERGENTLY AT (B)(6) HOSPITAL, (B)(6) BY DR. (B)(6). A MINI VISION RX 2.25 X 8 MM AND A VISION RX 2.75 X 15 MM WERE IMPLANTED IN THE MID RCA, A MINI VISION RX 2.5 X 15 MM WAS IMPLANTED IN THE PROXIMAL RCA, AND A MINI VISION RX 2.5 X 12 MM WAS IMPLANTED IN THE DISTAL RCA. FOUR YEARS LATER, THE PATIENT WAS RE-ADMITTED ON (B)(6) 2017 WITH LIGHTHEADEDNESS, DIZZINESS, ANGINA AND ANOTHER MYOCARDIAL INFARCTION. THE PATIENT STATED HE WAS TOLD THAT ALL FOUR OF THE PREVIOUSLY PLACED STENTS WERE 100% BLOCKED; ALTHOUGH HE WAS NOT TOLD WHETHER THIS WAS DUE TO THROMBOSIS OR RE-STENOSIS. TWO ADDITIONAL UNKNOWN STENTS WERE EMERGENTLY IMPLANTED AS TREATMENT AT FLORIDA HOSPITAL BY DR. (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Myocardial Infarction; Occlusion

  MAUDE report 7843585 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE HAD A MYOCARDIAL INFARCTION IN THE RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2013. FOUR VISION STENTS WERE IMPLANTED EMERGENTLY AT (B)(6) BY DR. (B)(6). A MINI VISION RX 2.25 X 8 MM AND A VISION RX 2.75 X 15 MM WERE IMPLANTED IN THE MID RCA, A MINI VISION RX 2.5 X 15 MM WAS IMPLANTED IN THE PROXIMAL RCA, AND A MINI VISION RX 2.5 X 12 MM WAS IMPLANTED IN THE DISTAL RCA. FOUR YEARS LATER, THE PATIENT WAS RE-ADMITTED ON (B)(6) 2017 WITH LIGHTHEADEDNESS, DIZZINESS, ANGINA AND ANOTHER MYOCARDIAL INFARCTION. THE PATIENT STATED HE WAS TOLD THAT ALL FOUR OF THE PREVIOUSLY PLACED STENTS WERE 100% BLOCKED; ALTHOUGH HE WAS NOT TOLD WHETHER THIS WAS DUE TO THROMBOSIS OR RE-STENOSIS. TWO ADDITIONAL UNKNOWN STENTS WERE EMERGENTLY IMPLANTED AS TREATMENT AT (B)(6) BY DR. (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Myocardial Infarction; Occlusion

  MAUDE report 7843580 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, TWO RX VISION STENTS (2.75 X 12MM AND 2.5 X 28MM) WERE IMPLANTED. PRIOR TO THE PROCEDURE, THE PATIENT WAS EXPERIENCING CHEST PAIN. A DAY AFTER THE PROCEDURE, THE PATIENT WAS EXPERIENCING CHEST PAIN, SWEATS, SHORTNESS OF BREATH, NAUSEA AND OVERALL NOT FEELING WELL. PATIENT WENT TO HOSPITAL TO CHECK ON HER ALLERGIC REACTION AND WAS DIAGNOSED WITH A BACTERIAL INFECTION IN THE RIGHT LYMPH NODE. THE PHYSICIAN COULD NOT STATE WHETHER THERE WAS A RELATIONSHIP BETWEEN THE STENTS AND THE BACTERIAL INFECTION. PATIENT STATES THAT THEY WERE ALLERGIC TO COBALT CHROMIUM AND WAS NOT INFORMED BY THE PHYSICIAN PRIOR TO THE PROCEDURE THAT BOTH VISION STENTS CONTAINED SUCH METAL WHICH CAUSED THIS ALLERGIC REACTION TO THE PATIENT. PATIENT WAS PROVIDED WITH AN ANTIBIOTIC. AN ECHOCARDIOGRAM WAS PERFORMED ON (B)(6) 2018 BUT RESULTS WERE INCONCLUSIVE. ADDITIONALLY, PATIENT DEVELOPED SWELLING ON HER LEFT ANKLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Diaphoresis; Dyspnea; Hypersensitivity/Allergic reaction; Nausea; Swelling; Unspecified Infection

  MAUDE report 7718951 ↗
• 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 ↗
• InjuryMar 23, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN 2016, A MINI VISION STENT WAS IMPLANTED IN THE CORONARY ARTERY. ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN AND ELEVATED BLOOD SUGARS. ON (B)(6) 2018, AN ANGIOGRAM WAS PERFORMED. THE PREVIOUSLY IMPLANTED STENT WAS TREATED AND ANOTHER STENT WAS IMPLANTED. THE EVENT RESOLVED AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; High Blood Pressure/ Hypertension; Occlusion

  MAUDE report 7367928 ↗

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