Reported Feb 26, 2025 · Ongoing
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty:…
Spectranetics Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectranetics Corporation · 9965 Federal Dr · Colorado Springs, CO · 80921-3822
Is this the product you have?
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty
8 of 8 products
| Model / number | Product as published |
|---|---|
154150041 | (4F,1.5-4.5mm), 150cm |
154150042 | Tack, 4F Gen 1.5, 150cm CE |
156135061 | Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm |
206135061 | (6F, 4.0 - 8.0mm), 135cm |
206135062 | Tack, 6F Gen 2.0, 135cm CE |
156135062 | Tack, 6F Gen 1.5, 135cm CE |
206080062 | Tack, 6F Gen 2.0, 80cm CE |
156080062 | Tack, 6F Gen 1.5, 80cm CE |
- Lot codes and dates
- UDI-DIREF/UDI-DI/Batch: 154150041/00863328000189/332905 - 349049, 154150042/328641
- REF
154090042/322101156135061/00863328000103/332824 - 336121206135061/00850003494043/331281 - 336152206135062/328643 - 345567156135062/271330 - 283066206080062/321083 - 349035156080062/302251 - 349034
- Amount recalled
- 2,939
Where it was sold
- Nationwide
- DE
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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