FDA Device Intelligence
Home › Lepu Medical Technology (Beijing) Co.,Ltd. › Angioway

Angioway

Lepu Medical Technology (Beijing) Co.,Ltd. · Model LP-P-30-YNP20H · UDI-DI 06936733736005

DTLPTM Prescription
10
510(k) clearances
2,152
Adverse events (18 deaths)
59
Recalls
144
Facilities

Description

Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary angioplasty, PTCA; stent Implantation operation) provides the pressure inside the balloon.

Recalls

DateFirmReason
2026-03-24Medline Industries, LPMedline has identified the presence of particulate within the fluid path of the Manifolds.
2026-03-24Medline Industries, LPMedline has identified the presence of particulate within the fluid path of the Manifolds.
2026-03-24Medline Industries, LPMedline has identified the presence of particulate within the fluid path of the Manifolds.
2026-02-27Medline Industries, LPMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection
2025-08-04Merit Medical Systems, Inc.Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemor
2025-07-25Merit Medical Systems, Inc.Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-04-05Boston Scientific CorporationThe firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
2023-04-05Boston Scientific CorporationThe firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
2022-03-01Merit Medical Systems, Inc.A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.