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2Way Foley Balloon Catheter

AP MDS Co., Ltd. · Model APO-FC-012 · UDI-DI 08800109201528

EZL

510(k) clearances

9,331

Adverse events (12 deaths)

Recalls

115

Facilities

Description

This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifold part and a Shaft parts. The Manifold Parts is equipped with a non-return valve for inflate the balloon and a band to fix the non-return valve and to identify the catheter’s size by color. The Shaft parts has an x-ray opaque line for check to position and balloon for located the catheter in the bladder, a drainage eye for urine drainage, and a rounded tip for easy insertion of the shaft. The proposed device is supplied in French size ranging from 12 to 24. It is available in 337(±15) and 345(±15) mm length with various balloon sizes. The devices are applied for adults only.

Recalls

Date	Firm	Reason
2026-04-23	C.R. Bard Inc	Due to stain present on the surface of affected foley catheters.
2025-06-18	C.R. Bard Inc	Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfuncti
2024-12-02	Coloplast Manufacturing US, LLC	A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
2024-12-02	Coloplast Manufacturing US, LLC	A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
2023-12-04	Cardinal Health 200, LLC	Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
2023-11-06	Nurse Assist, LLC	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in
2021-08-05	C.R. Bard Inc	There is potential for packaging defects that may impact the sterile barrier.
2021-08-05	C.R. Bard Inc	There is potential for packaging defects that may impact the sterile barrier.
2021-08-05	C.R. Bard Inc	There is potential for packaging defects that may impact the sterile barrier.
2021-08-05	C.R. Bard Inc	There is potential for packaging defects that may impact the sterile barrier.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.