BrosMed Medical Co.,Ltd.: Medical Device Recall in 2019 - (Recall #: Z-0963-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 14, 2018

Date Posted: March 6, 2019

Recall Number: Z-0963-2019

Event ID: 81973

Reason for Recall:

Incorrect (higher) Rated Burst Pressure information printed on label.

Status: Terminated

Product Quantity: 400

Code Information:

Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.

Distribution Pattern:

US Distribution to MO.

Voluntary or Mandated:

Voluntary: Firm initiated