FDA Medical Device Recalls (openFDA)
BrosMed Medical Co.,Ltd.: 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.
- Recall number
- Z-0963-2019
- Recalling firm
- BrosMed Medical Co.,Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2018-12-14
- Posted
- not on file
- Terminated
- 2020-12-11
- Reason
- Incorrect (higher) Rated Burst Pressure information printed on label.
- Root cause
- Employee error
- Action
- On December 7, 2018 the firm, BrosMed Medical, sent an "URGENT FIELD SAFETY NOTICE" dated December 7, 2018 to their consignee. The notice described the product, problem and actions to be taken. The consignee was instructed to do the following: " Please reference the Attachment 1 for the list of Hermes NC PTA Balloon Dilatation Catheter with affected catalogue numbers and lots numbers. . Immediately stop selling the device from these lots. " Transfer this notification and inform relevant distributors/hospitals/clinics to check their inventory, complete and return the Effectiveness Check form in attachment 2 to you, and return the affected unused Identified Hermes NC PTA Balloon Dilatation Catheters back to your warehouse, if any. " Please help collect the unused identified Hermes NC PTA Balloon Dilatation Catheters from relevant distributors/hospitals/clinics to your warehouse as well collect the Effectiveness Check Forms. " Review your inventory, complete the Effectiveness Check Forms in attachment 2 to BrosMed Medical and return all unused identified products including the collections in your warehouse to BrosMed Medical, if any . This action does not affect patients having successfully undergone interventional procedures using these devices. What is BrosMed Medical doing? BrosMed Medical has already implemented corrective actions to ensure ongoing product performance. BrosMed Medical will work with you to replace the return units with similar products. The appropriate regulatory agencies have been notified of this action. If you have any question, please do not hesitate to contact BrosMed Medical: E-mail: cs@brosmed.eu at Tel: +31850140 901.
- Quantity
- 400
- Distribution
- US Distribution to MO.
- Lot, serial or model codes
- Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.
- 510(k) numbers
- ["K160941"]
- PMA numbers
- not on file
- Product code
- LIT
- Firm FEI
- 3010391265
- Firm city
- Dongguan
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28