Recall Z-1070-2025
Spectranetics Corporation · initiated January 10, 2025
Class I – dangerous or defective products that could cause serious health problems or death
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: 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
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.
FDA-determined cause: Device Design
Action taken
On 1/10/2025, Philips mailed recall notices to customers informing them of the following: Firm will no longer distributed the device. Check your product inventory and quarantine any affected devices to prevent use. Do not open or use any products that have been identified within your inventory. Circulate this notice to all users of the device, or to any organization where the affected product may have been transferred, so they are aware of the product Recall. Complete and return the response form via email to igtdc.r@philips.com
Details
- Recall number
- Z-1070-2025
- Initiated
- January 10, 2025
- Posted by FDA
- February 14, 2025
- Product code
- QCT – Scaffold, Dissection Repair
- Quantity
- 2,939
- Distribution
- Distribution US nationwide and countries of: NL, DE, NL, AU, IT, CH, GB, and AT
- Recalling firm
- Spectranetics Corporation, Colorado Springs, CO