# FDA recall Z-1070-2025

> **Spectranetics Corporation** · Class I · device recall initiated 2025-01-10.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1070-2025
- **Recalling firm:** Spectranetics Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-10
- **Report date:** 2025-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Colorado Springs, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1070-2025

## Citation

> AI Analytics. FDA recall Z-1070-2025. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-1070-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*