Z-1070-2025Class I

Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following...

Name: Z-1070-2025 Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following...
Creator: Spectranetics Corporation
Published: 2025-01-10
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2025-01-10 / Open, Classified / root cause: design

FDA source

Spectranetics Corporation began a recall of Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041... on 2025-01-10. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1070-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-01-10
Posted: 2025-02-14
Recalling firm: Spectranetics Corp.
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
Product code: QCT Scaffold, Dissection Repair
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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]
Quantity in commerce: 2,939
Distribution: Distribution US nationwide and countries of: NL, DE, NL, AU, IT, CH, GB, and AT
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1070-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1070-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-14

Product code QCT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)