Tack Endovascular System (6F, 3.5-6.0mm) 156120061Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00863328000103), received between May 27, 2020 and Oct 1, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

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 problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗