Tack Endovascular System (4F, 1.5-4.5mm) 154150041Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00863328000196), received between Jun 21, 2021 and Jul 3, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, 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 TACK WAS DEPLOYED SUCCESSFULLY. HOWEVER, DURING REMOVAL, THE TES GOT STUCK ON A 0.014" NON-PHILIPS GUIDEWIRE AND HAD TO BE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDEWIRE IN ORDER TO DELIVER A BALLOON FOR POST DILATION. 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 19672022 ↗
• MalfunctionJul 3, 2024Entrapment of Device; Entrapment of Device

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, A TACK WAS DEPLOYED SUCCESSFULLY. HOWEVER, DURING REMOVAL, THE TES GOT STUCK ON A 0.014" NON-PHILIPS GUIDEWIRE AND HAD TO BE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDEWIRE IN ORDER TO DELIVER A BALLOON FOR POST DILATION. 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 19671930 ↗
• MalfunctionJul 3, 2024Entrapment of Device; Entrapment of Device

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, THE TES GOT STUCK ON A 0.014" NON-PHILIPS GUIDEWIRE AND HAD TO BE REMOVED AS A SYSTEM. AN EXTENDED BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 19671664 ↗
• MalfunctionJul 3, 2024Entrapment of Device; Entrapment of Device

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, THE TES WAS ABLE TO ADVANCE WELL AND 3 OF THE 4 TACKS WERE DEPLOYED SUCCESSFULLY. HOWEVER, DURING REMOVAL, THE TES GOT STUCK HALFWAY OUT, AND HAD TO PULL THE TES AND GUIDEWIRE AS A UNIT. A NEW GUIDE WIRE WAS INSERTED TO COMPLETE THE PROCEDURE. 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 19671540 ↗
• MalfunctionJul 3, 2024Entrapment of Device; Entrapment of Device

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, THE TES WAS ABLE TO ADVANCE WELL AND TACKS WERE DEPLOYED SUCCESSFULLY. HOWEVER, DURING REMOVAL, THE TES GOT STUCK HALFWAY OUT, AND HAD TO PULL THE TES AND GUIDEWIRE AS A UNIT. A NEW GUIDE WIRE WAS INSERTED TO COMPLETE THE PROCEDURE. 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 19671521 ↗
• MalfunctionJul 3, 2024Ejection Problem; Ejection Problem

  THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED IN A PERIPHERAL PROCEDURE. UPON ENTERING THE SHEATH, A TACK WAS INADVERTENTLY DEPLOYED BUT WAS ABLE TO BE REMOVED FROM THE ENTRANCE OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A STENT. 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 19665700 ↗
• MalfunctionJun 21, 2021Inadequacy of Device Shape and/or Size; Unintended Movement; Inadequacy of Device Shape and/or Size; Unintended Movement

  THE REPORTER STATED "THE DEVICE WAS ORIGINALLY IMPLANTED (B)(6) 2021 AND TODAY THEY NOTICED DURING THE ANGIOGRAM THAT THE DEVICES HAVE MOVED. PRIOR TO AN INTERVENTION ON ANOTHER VESSEL ALTOGETHER." "IT WAS NOTICED THAT THE DEVICES HAD MOVED BETWEEN THIS PROCEDURE AND THE INITIAL PROCEDURE PERFORMED ON THE (B)(6) 2021." "IT IS IMPORTANT TO NOTE THAT THE MOVEMENT OF THESE DEVICES WERE NOTICED PRIOR TO ANY ADDITIONAL INTERNATIONAL MEASURES BEING TAKEN. BEFORE ANY WIRES REACHED THE STENT THEMSELVES. SOMETHING HAPPENED IN BETWEEN THE PROCEDURES AND CAUSED THE DEVICES TO MOVE. IT WAS NOTED VIA ANGIOGRAM DURING THE INITIAL RUN OFF BEFORE ANY WIRES WENT DOWN TO THE AREA." FOUR TACK ENDOVASCULAR DEVICES (TACKS) WERE IMPLANTED ON (B)(6) 2021 FOR TREATMENT OF A SIGNIFICANT SPIRAL DISSECTION IN THE TIBIAL PERONEAL TRUNK AS PART OF PURCUTANEOUS ATHERECTOMY PROCEDURE FOR A NON-HEALING ULCER OF LOWER EXTREMITY. POST-PROCEDURE ANGIOGRAMS ON (B)(6) 2021 SHOWED THE FOUR TACKS IMPLANTED PROPERLY AT THE DESIRED LOCATION IN THE VESSEL. ON A SUBSEQUENT ANGIOGRAM FROM (B)(6) 2021, THE THREE MOST DISTAL TACKS WERE SEEN IN ALTERED POSITIONS FROM THEIR ORIGINAL PLACEMENT. THREE TACKS APPEAR TO HAVE MOVED PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031330 ↗