Tack Endovascular System (6F, 3.5-6.0mm)Recalls & reported problems across all models

We found 2 models of Tack Endovascular System (6F, 3.5-6.0mm) by Intact Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between May 27, 2020 and Jul 3, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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, 3.5-6.0mm) 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, 3.5-6.0mm) problems

Tack Endovascular System (6F, 3.5-6.0mm) models

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

• Tack Endovascular System (6F, 3.5-6.0mm) 156120061

  Scaffold, Dissection Repair
  1 recall2 reports
• Tack Endovascular System (6F, 3.5-6.0mm) 156135061

  Scaffold, Dissection Repair
  3 reports

Recent Tack Endovascular System (6F, 3.5-6.0mm) adverse event reports

The 5 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Entrapment of Device; Entrapment of Device

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, A 0.035" NON-PHILIPS GUIDEWIRE LOOPED INSIDE THE TES AND WOULD NOT EXIT THE DISTAL END. DURING REMOVAL, IT WOULD NOT BUDGE, THUS REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW TES. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671629 ↗
• InjuryApr 4, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED TO TREAT A SLIGHTLY CALCIFIED SOFT TISSUE IN THE TIBIOPERONEAL TRUNK (TP). THE FIRST TACK WAS DEPLOYED IN THE DISTAL TP AT THE ORIGIN OF THE OCCLUDED POSTERIOR TIBIAL ARTERY. THE SECOND TACK WAS DEPLOYED IN THE MIDDLE TP, AND THE THIRD TACK WENT IN TO THE PROXIMAL TP AT THE ORIGIN OF THE ANTERIOR TIBIAL ARTERY. ANGIOGRAM SHOWED A RESIDUAL DISSECTION BETWEEN THE SECOND AND THIRD TACK. WITHOUT POST DILATING, A FORTH TACK WAS DEPLOYED BETWEEN THE SECOND AND THIRD TACK TO TREAT THE RESIDUAL DISSECTION. HOWEVER, AS THE PHYSICIAN WAS MANEUVERING THE DELIVERY SYSTEM THROUGH THE THIRD TACK, IT GOT CAUGHT AND MALFORMED THE TACKS. A BAILOUT STENT WAS PLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT IS BEING SUBMITTED DUE TO A BAILOUT STENT REQUIRED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678142 ↗
• InjuryFeb 26, 2021Unintended Collision; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Unintended Collision; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  THE PATIENT, WHO WAS NOTED TO HAVE SLIGHTLY TORTUOUS VESSELS, UNDERWENT DRUG COATED BALLOON (DCB) ANGIOPLASTY GUIDED BY INTRAVENOUS ULTRASOUND (5MMX40MM) IN THE POSTERIOR POPLITEAL AND PROXIMAL SUPERFISCIAL FEMORAL ARTERY (SFA). SMALL DISSECTIONS WERE NOTED IN THE TREATMENT AREA PRIOR TO DRUG COATED BALLOONING. DCB (5X200MM) WAS PERFORMED IN THE (SFA) AND EXTENDED THE DISSECTIONS IN BOTH THE POSTERIOR POPLITEAL ARTERY AND THE PROXIMAL SFA. INTACT VASCULAR TACKS (3.5-6.0MM) WERE PLACED OVER THE DISSECTIONS IN BOTH THE POSTERIOR POPLITEAL ARTERY AND THE PROXIMAL SFA. ONE TACK WAS PLACED IN THE POSTERIOR POPLITEAL ARTERY AND FOUR TACKS WERE PLACED IN THE PROXIMAL SFA TO TREAT THE DISSECTIONS. ALL TACKS WERE POST-DILATED WITH A 5MM BALLOON. A SUBSEQUENT ANGIOGRAM OF THE SFA SHOWED THE DISSECTION WAS NOT RESOLVED. THE OPERATING PHYSICIAN OPTED TO PERFORM A SUBSEQUENT POST-DILATION WITH ANOTHER 5MM BALLOON. WHEN MOVING THE BALLOON THROUGH THE AREA OF THE SFA WHERE THE FOUR TACKS HAD BEEN PLACED, THE BALLOON INTERACTED WITH THE THIRD TACK AS IT PASSED. THE THIRD TACK WAS DISPLACED AND DURING THE ATTEMPT TO CROSS THE TACK INPLANT, THE THIRD TACK GOT FURTHER DISPLACED INTO THE FOURTH TACK A

  Patient problems: Failure of Implant

  MAUDE report 11385374 ↗
• InjuryOct 1, 2020Device Dislodged or Dislocated

  NON-COMPLIANT PATIENT UNDERWENT MULTIPLE ENDOVASCULAR INTERVENTIONS. TACK IMPLANTATION PROCEDURE OCCURRED ON (B)(6) 2020. THIS PROCEDURE WAS PERFORMED 12 MONTHS POST ATHERECTOMY AND DCB INTERVENTION AS PATIENT RETURNED WITH RECURRENT SYMPTOMS. PATIENT RECEIVED 9 (NINE) TACK IMPLANTS AND END RESULT OF THE PROCEDURE SHOWED DISSECTIONS TREATED WITH GOOD FLOW. PATIENT RETURNED 7.5 MONTHS LATER ON (B)(6) 2020 WITH SYMPTOMATIC PAIN AND WAS FOUND TO HAVE THE PRIOR TREATED SUPERIOR FEMORAL ARTERY (SFA) OCCLUDED INCLUDING THE TACK IMPLANTED REGION (DISTAL SFA TO P2). PHYSICIAN OBSERVED THE PATIENT WAS STILL NON-COMPLIANT (CONTINUED SMOKING AND NOT TAKING PRESCRIBED MEDICATION). PHYSICIAN DECIDED TO PERFORM ANOTHER ENDOVASCULAR PROCEDURE AND USED PENUMBRA CAT 8 & 6 DEVICES AND FOLLOWED WITH USE OF ANGIOJET AND ENDED THE PROCEDURE WITH USE OF MEDTRONIC SE STENT OVER ALL TACK IMPLANTS. AT THE END OF THE PROCEDURE, ONE OUT OF THE NINE TACK IMPLANTS WAS OBSERVED TO BE DISPLACED IN ANTERIOR TIBIAL REGION. PHYSICIAN CONCLUDED THE PROCEDURE STATING, NO FURTHER INTERVENTION NECESSARY. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AND IS VIABLE FOR FUTURE FEMORAL/TIBIAL BYPASS PROCEDURE OPTIONS.

  Patient problems: Pain

  MAUDE report 10614092 ↗
• InjuryMay 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE ON (B)(6) 2020. TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM) WAS USED TO TREAT DISSECTIONS OBSERVED. DISPLACEMENT OF THE DEPLOYED TACK IMPLANT(S) WAS OBSERVED. DURING THE INDEX PROCEDURE ON (B)(6) 2020, THE PHYSICIAN DEPLOYED THREE TACK IMPLANTS IN RIGHT SUPERIOR FEMORAL ARTERY (SFA) AND FOLLOWED POST DILATATION OF THE TACK IMPLANTS, DISPLACEMENT OF THE TACK IMPLANT(S) WAS OBSERVED BY THE PHYSICIAN. THE PHYSICIAN THEN PROCEEDED TO DEPLOY ELUVIA DES WITHIN THE SFA AND OBSERVED ADDITIONAL TACK IMPLANT(S) DISPLACEMENT. UNSUCCESSFUL ATTEMPTS WERE MADE BY THE PHYSICIAN TO SNARE THE DISPLACED TACK IMPLANTS. THE PHYSICIAN COMPLETED THE PROCEDURE BY PERFORMING ANOTHER POST DILATATION STEP. THE CONCLUSION OF THE INDEX PROCEDURE, HAD THE TACK IMPLANT(S) DISPLACED FROM MID-SFA TO P1 REGION, ANGIOGRAPHY DEMONSTRATED GOOD BLOOD FLOW. THE PHYSICIAN DOCUMENTED REQUIRED PATIENT FOLLOW-UP WITH ULTRASOUND. PATIENT ULTRASOUND WAS TAKEN, AND THE PHYSICIAN DECIDED TO RE-INTERVENE BASED ON THE RESULTS OF THE ULTRASOUND ON (B)(6) 2020. THE RE-INTERVENTION INCLUDED USE OF JETSTREAM ATHERECTOMY FOLLOWED BY PROLONGED ANGIOPLASTY NEAR THE TACK IMPLANTED REGION. THE CO

  Patient problems: Thrombus

  MAUDE report 10093192 ↗

Other Intact Vascular, Inc. products

• Tack Endovascular System (6F, 4.0-8.0mm)2 models · 7 reports · 1 recall