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Tack Endovascular System 4F

by Philips Image Guided Therapy Corporation (Formerly Intact)

PMA P190027

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 10 Apr 2020

PMA

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP190027 Date10 Apr 2020Approval withdrawnStatusWithdrawn

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1070-2025 FDA Class I initiated 10 Jan 2025

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Trade Name
Tack Endovascular System (4F, 1.5-4.5mm)
Generic Name
Scaffold, dissection repair
PMA Number
FDA Product Code
QCT
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APWD Approval withdrawn