Device product
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
Z-0963-2019
Product summary
- Event
- Event 81973
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400
- Official record key
device-enforcement:Z-0963-2019
Official wording
Reason: Incorrect (higher) Rated Burst Pressure information printed on label.
Code information: Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.
Distribution pattern: US Distribution to MO.
Derived failure modes
-
Unknown
Incorrect (higher) Rated Burst Pressure information printed on label.