Paclitaxel-coated Balloons (pcb) And Paclitaxel-eluting Stents (pes) For The Treatment Of Peripheral Arterial Disease (pad) And The Potential Risk Of Long-term All-cause Mortality
Recall Summary The FDA is recalling paclitaxel-coated balloons and paclitaxel-eluting stents used to treat peripheral arterial disease due to a potential increased risk of long-term death from all causes in patients who receive these devices. These medical devices are distributed throughout Canada. Patients who have received these devices should consult their healthcare provider about their individual situation.
- Product
- Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES)
- Reason
- Product safety
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DRUGS
- Recall date
- 2024-02-20
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DRUGS
Recall details on Nibble Recalls: https://trynibble.app/recalls/500ca4ed-3251-4899-8a95-ad99c65cd7d2