Spectranetics Corporation: Device Recall

Recall Details

Recall Number

Z-1070-2025

Classification

Class I

Product Type

Device

Recalling Firm

Spectranetics Corporation

Status

Ongoing

Date Initiated

01/10/2025

Location

Colorado Springs, CO, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2,939

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.

Product Description

Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061; Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 156080062

Distribution Pattern

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

Other Recalls by Spectranetics Corporation

• Class II: Risk 11/25/2024
  Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

View all recalls by Spectranetics Corporation →