Tack Endovascular System (6F, 4.0-8.0mm)Recalls & reported problems across all models

We found 2 models of Tack Endovascular System (6F, 4.0-8.0mm) by Intact Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Jun 23, 2021 and Nov 4, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

Tack Endovascular System (6F, 4.0-8.0mm) recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 10, 2025Class IOpen, Classified

   Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.

   Z-1070-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Tack Endovascular System (6F, 4.0-8.0mm) problems

Tack Endovascular System (6F, 4.0-8.0mm) models

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

• Tack Endovascular System (6F, 4.0-8.0mm) 206120061

  Scaffold, Dissection Repair
  1 recall0 reports
• Tack Endovascular System (6F, 4.0-8.0mm) 206135061

  Scaffold, Dissection Repair
  7 reports

Recent Tack Endovascular System (6F, 4.0-8.0mm) adverse event reports

The 7 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Ejection Problem; Ejection Problem

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED TO TREAT THE DISTAL SFA. THE FIRST FIVE TACKS WERE DEPLOYED SUCCESSFULLY. THE SIXTH TACK WAS NOT INTENDED TO BE DEPLOYED; HOWEVER, THE PATIENT MOVED HER LEG, AND WAS INADVERTENTLY DEPLOYED IN THE COMMON FEMORAL ARTERY. AN ATTEMPT WAS MADE TO RETRIEVE THE TACK BY PUTTING THE SHEATH OVER IT BUT COULD NOT BE RETRIEVED. A BALLOON WAS USED TO POST DILATE AND TO ENSURE PROPER WALL APPOSITION OF THE SIXTH TACK. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE SIXTH TACK WAS INADVERTENTLY DEPLOYED, REQUIRING ADDITIONAL INTERVENTION, BUT RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20599624 ↗
• InjuryJul 8, 2024Positioning Failure; Positioning Failure

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED TO TREAT THE SFA LESION. THREE TACKS WERE DEPLOYED INSIDE THE PATIENT; HOWEVER, ONE TACK WAS SLIGHTLY TILTED. IN ORDER TO ACHIEVE THE DESIRED OUTCOME, THE PHYSICIAN ELECTED TO STENT THE MOST DISTAL TACK, EVEN THOUGH LEAVING IT SLIGHTLY TILTED IN PLACE WAS NOT EXPECTED TO CAUSE ANY RISK OR HARM TO THE PATIENT. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY DUE TO THE TACK POSITION; RESULTING IN ELECTED STENT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696745 ↗
• MalfunctionJul 3, 2024Positioning Problem; Positioning Problem

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED IN A PERIPHERAL PROCEDURE IN THE DISTAL COMMON FEMORAL ARTERY. DURING USE, A TACK WAS DEPLOYED IN THE ARTERY, REMOVED THE DEVICE, AND PERFORMED ANGIO. THE PHYSICIAN WANTED TO PLACE A SECOND TACK PROXIMAL TO THE ORIGINAL TACK LOCATION; HOWEVER, DID NOT POST DILATE THE FIRST TACK AND PUSHED THE TACK FURTHER DOWN THE ARTERY. THE SYSTEM WAS REMOVED WITHOUT DEPLOYING THE SECOND TACK, AND A BALLOON WAS USED TO POST DILATE THE TACK. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED AND NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE TACK MIGRATED. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667677 ↗
• MalfunctionJul 3, 2024Ejection Problem; Ejection Problem

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, ONE TACK WAS DEPLOYED SUCCESSFULLY IN THE POPLITEAL ARTERY. THE PHYSICIAN PLANNED TO DEPLOY ADDITIONAL TACKS IN THE OTHER AREAS OF THE SFA, WHICH REQUIRED THE DEVICE TO BE REMOVED FROM THE PATIENT IN ORDER TO REPOSITION. AS THE DEVICE WAS BEING PULLED OVER THE WIRE OUTSIDE OF THE PATIENT'S BODY, THE OUTER SHEATH RETRACTED, AND UNINTENTIONALLY DEPLOYED THE REMAINING 5 TACKS. THE PROCEDURE WAS COMPLETED USING A REGULAR STENT TO TREAT THE SFA. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE TACK INADVERTENTLY DEPLOYED. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665820 ↗
• MalfunctionNov 17, 2022Material Separation; Material Separation

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED TO TREAT THE SLIGHTLY TORTUOUS AND MODERATELY CALCIFIED PERIPHERAL LESIONS. FOUR TACKS WERE DEPLOYED SUCCESSFULLY. DURING REMOVAL, IT WAS NOTED THAT THE DISTAL PORTION OF THE INNER CORE SEPARATED INSIDE THE INTRODUCER SHEATH. THE INTRODUCER SHEATH WAS REMOVED WITH THE SEPARATED TES CONTAINED WITHIN THE SHEATH. IMAGING CONFIRMED NO PIECE WAS RETAINED INSIDE THE BODY. THE SAME INTRODUCER SHEATH WAS PLACED BACK INSIDE THE PATIENT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE SHAFT SEPARATION. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15813490 ↗
• MalfunctionNov 23, 2021Unintended Collision; Device Damaged by Another Device; Unintended Collision; Device Damaged by Another Device

  FIVE 4-8MM TACKS WERE PLACED IN PROXIMAL/MID SFA AROUND (B)(6) 2021. PATIENT HAD BEEN ON DUAL ANTIPLATET THERAPY FROM PRIOR PROCEDURE. INITIAL ANGIOGRAM SHOWED PATENT TACKS AND SFA, WITH A LONG DISSECTION PRESENT IN DISTAL SFA/PROXIMAL POPLITEAL. WE THEN USED 0.014 IVUS TO EVALUATE DISSECTIONS, VESSEL SIZE, DISEASE BURDEN/MORPHOLOGY, IN POPLITEAL, AS PHYSICIAN PRE-PROCEDURE HAD PLANNED ON STENTING WITH SUPERA STENT IN POP AND ELUVIA IN SFA IF NEEDED. IVUS SHOWED SOFT ECCENTRIC PLAQUE IN POPLITEAL AROUND 80% STENOSIS. THERE WAS ALSO A LONG DISSECTION PLANE FROM PROXIMAL POPLITEAL INTO DISTAL SFA, AS WELL AS SOME OTHER AREAS OF DISSECTION THROUGHOUT THE SFA. PHYSICIAN WANTED TO USE HAWK ATHERECTOMY FOR POPLITEAL. ADVISED PHYSICIAN TO PROCEED WITH CAUTION THROUGH TACKS SINCE SOMEWHAT RECENT PLACEMENT, AND THAT THE HAWK MAY BE TO "BULKY" TO PASS THROUGH TWO OF THE PROXIMAL TACKS THAT WEREN'T FULLY EXPANDED DUE TO SOME RESIDUAL DISEASE. SPIDER FILTER/WIRE WAS PLACED INTO THE DISTAL POPLITEAL AND THEN HAWK INSERTED. AT ONE POINT PHYSICIAN HAD SOME DIFFICULTY PASSING HAWK IN SFA. AFTER THREE PASSES WITH THE HAWK, IT WAS REMOVED, AND PHYSICIAN REQUESTED A STELLAREX FOR THE POPLITEAL. NO IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862680 ↗
• MalfunctionJun 23, 2021Unintended Collision; Device Damaged by Another Device; Unintended Collision; Device Damaged by Another Device

  UPON POST DILATION OF THE TACKS, THE BALLOON PASSED THE FIRST TACK WITHOUT ISSUE BUT CAME INTO CONTACT WITH THE SECOND TACK. THE BALLOON BECAME CAUGHT ON THE SECOND TACK. THE BALLOON PUSHED THE TACK SIDEWAYS IN THE VESSEL AND THEN DOWN THE SUPERFICIAL FEMORAL ARTERY (SFA). EVENTUALLY, THE OPERATOR WAS ABLE TO USE A STENT TO OVERLAY THE DISPLACED TACK, SECURING IT AGAINST THE VESSEL WALL. A SELF-EXPANDING STENT WAS PLACED IN THE PROXIMAL SFA TO COVER THE DISSECTIONS. AT THE CONCLUSION OF THE PROCEDURE, THERE WAS COMPLETE FLOW THROUGH THE SFA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051440 ↗

Other Intact Vascular, Inc. products

• Tack Endovascular System (6F, 3.5-6.0mm)2 models · 5 reports · 1 recall