Spectranetics Corporation medical device recall: Intact Vascular Tack Endovascular System
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96097
- Recall initiated
- Jan 10, 2025
- Classified by FDA
- Feb 14, 2025
- Posted in Enforcement Report
- Feb 26, 2025
- Recalling firm
- Spectranetics Corporation
- Firm location
- Colorado Springs, CO, United States
- Initiated by
- Voluntary: Firm initiated
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jan 10, 2025. FDA classified it 35 days later, on Feb 14, 2025. Distribution reported by FDA: Distribution US nationwide and countries of: NL, DE, NL, AU, IT, CH, GB, and AT Spectranetics Corporation has 11 recalls in our records.
Recalled products (1)
Z-1070-2025 Class I Ongoing
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
Codes / 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
Quantity: 2,939
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96097
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.