Agency classClass IOur severity:Critical FDA (Devices)·Z-1070-2025·Announced 2025-02-26

Vascular Tack Endovascular System recalled for deployment and migration risks

Spectranetics' Intact Vascular Tack Endovascular System may fail to deploy properly or migrate in blood vessels, potentially causing ischemia and requiring additional intervention.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification qualifies this recall as Critical per the rubric. The documented hazards—including device migration, deployment failure, and ischemia (tissue death from blood flow loss)—represent serious potential for patient harm.

Plain-English summary

Spectranetics Corporation is recalling the Intact Vascular Tack Endovascular System, a medical device designed to treat acute tears (dissections) in artery linings by securing damaged tissue to the inner vessel wall using small tack implants. The FDA classified this recall as Class I due to potential problems with device deployment and stability after placement in blood vessels.

When the tack system does not deploy or remain stable as intended, it may fail to resolve the dissection, allowing the implant to migrate within the vessel. Patients may require additional interventions including bailout stenting, re-treatment, or unintended removal of tack devices. The most serious potential consequence is ischemia—a dangerous reduction in blood flow that can damage or kill tissue.

Approximately 2,939 units of the Intact Vascular Tack Endovascular System have been distributed across the United States and internationally. Healthcare providers should immediately discontinue use and consult with the FDA and Spectranetics regarding patient management options for patients who have received these devices.

The recalled product

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…
Manufacturer: Spectranetics Corporation
Category: Medical Device — Cardiovascular / Vascular
Hazard: deployment-failure
device-migration
ischemia
device-malfunction
Affected units: 2,939

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Spectranetics Corporation

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