Intact Vascular Tack Endovascular System, to treat vascular… recallZ-1070-2025 · Spectranetics Corporation · initiated Jan 10, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spectranetics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-1070-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 10, 2025
- Posted by the FDA
- Feb 14, 2025
- Recalling firm
- Spectranetics Corporation
- Quantity
- 2,939
- Product code
- QCT
- FDA submissions
- P180034, P190027
- Distribution
- Distribution US nationwide and countries of: NL, DE, NL, AU, IT, CH, GB, and AT
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Tack Endovascular System (6F, 3.5-6.0mm) 156120061Intact Vascular, Inc. · Scaffold, Dissection Repair1 recall2 reports
- Tack Endovascular System (6F, 4.0-8.0mm) 206120061Intact Vascular, Inc. · Scaffold, Dissection Repair1 recall0 reports
- Tack Endovascular System (4F, 1.5-4.9mm) 154090041Intact Vascular, Inc. · Scaffold, Dissection Repair1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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