FDA Device recall Z-1070-2025
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm,…
- FDA Device
- Class I
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class I recall of Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm,… by Spectranetics, citing 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 probl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1070-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-01-10 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Spectranetics |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI: REF/UDI-DI/Batch: 154150041/00863328000189/332905 - 349049, 154150042/328641, REF: 154090042/322101, 156135061…UDI-DI: REF/UDI-DI/Batch: 154150041/00863328000189/332905 - 349049, 154150042/328641, REF: 154090042/322101, 156135061/00863328000103/332824 - 336121, 206135061/00850003494043/331281 - 336152, 206135062/328643 - 345567, 156135062/271330 - 283066, 206080062/321083 - 349035, 156080062/302251 - 349034 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Spectranetics
- Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 98993…
FDA Device · Class II · 2024-12-25 · Spectranetics - Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 42…
FDA Device · Class II · 2023-12-20 · Spectranetics - Philips Laser System, REF: LAS-100
FDA Device · Class II · 2022-11-23 · Spectranetics - Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
FDA Device · Class II · 2022-07-20 · Spectranetics - Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Out…
FDA Device · Class II · 2020-06-03 · Spectranetics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1070-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.