Intact Vascular Tack Endovascular System — Class I medical device recall Z-1070-2025
Ongoing recall by Spectranetics Corporation, reported 2025-02-26, distributed nationwide. Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by t
| Recall number | Z-1070-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectranetics Corporation, Colorado Springs, CO, United States |
| Recall initiated | 2025-01-10 |
| Classified | 2025-02-14 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 2,939 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00850003494043, 00863328000103, 00863328000189 |
| Lot numbers | 154150042/328641, 349049 |
| Model numbers | 154090042, 154090042/322101, 154150041, 154150042, 156080062, 156080062/302251, 156135061, 156135062, 156135062/271330, 206080062, 206080062/321083, 206135061, 206135062, 206135062/328643, 283066, 336121, 336152, 345567, 349034, 349035 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1070-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.