Device recall
Z-1070-2025: Intact Vascular Tack Endovascular System, to treat vascular dissections with…
FDA device recall · Class I · Spectranetics Corporation
Key facts
| Recall number (Z-number) | Z-1070-2025 |
|---|---|
| Recall event | 96097 |
| 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… |
| Product code | QCT |
| Recalling firm | Spectranetics Corporation |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P180034, P190027 |
| FEI number | 3007284006 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database