Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,

FDA device recall Z-1070-2025 · posted 2025-02-14 · Open, Classified

Recall details

Recalling firm

Spectranetics Corporation

Reason for recall

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.

Action taken

On 1/10/2025, Philips mailed recall notices to customers informing them of the following: Firm will no longer distributed the device. Check your product inventory and quarantine any affected devices to prevent use. Do not open or use any products that have been identified within your inventory. Circulate this notice to all users of the device, or to any organization where the affected product may have been transferred, so they are aware of the product Recall. Complete and return the response form via email to igtdc.r@philips.com

Root cause

Device Design

Status

Open, Classified

Product code

QCT

Quantity affected

2,939

Distribution

Distribution US nationwide and countries of: NL, DE, NL, AU, IT, CH, GB, and AT

Date initiated

2025-01-10

Date posted

2025-02-14

Location

Colorado Springs, CO