Spectranetics recalls vascular tack endovascular systems used to treat arterial dissections post-angioplasty due to potential deployment instability causing device failure or complications.
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.
Spectranetics is recalling endovascular systems designed to treat arterial dissections after angioplasty. The devices may become unstable in the vessel, leading to failed treatment, device migration, or other complications.
The system could deploy improperly in the artery, causing the device to shift or fail to stay in place. This might lead to the dissection not being resolved, the device moving, requiring additional procedures, or causing reduced blood flow.
Patients who received the recalled vascular tack systems during angioplasty procedures are affected. Those with the specific model numbers and reference codes listed are at risk of complications if the device becomes unstable.
Check for the product names and model numbers listed in the recall notice, including the reference codes and UDI-DI information provided. The specific product variants include 4F and 6F sizes with different lengths and generation numbers.
Review the product reference codes and UDI-DI information to confirm if your device is part of the recall.
The system may not deploy or stay stable in the artery after treatment, which could cause the dissection to worsen or require additional procedures.
Check the product reference codes and UDI-DI information to see if your device is recalled. Contact Spectranetics for further instructions.
The recall indicates potential complications like device migration or failed treatment, but the official notice does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Spectranetics to request your refund or repair — edit it as you like.
Subject: Recall Z-1070-2025 — Spectranetics Spectranetics Hello, I own a Spectranetics that is covered by recall Z-1070-2025 from Spectranetics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
