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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96097

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 10, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Spectranetics Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1070-2025
Recall number
Z-1070-2025
Initiated
January 10, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Spectranetics Corporation
Quantity
2,939

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

Code information

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 pattern

Distribution US nationwide and countries of: NL, DE, NL, AU, IT, CH, GB, and AT