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Angioway
Lepu Medical Technology (Beijing) Co.,Ltd. · Model LP-P-30-YNP50 · UDI-DI 06936733735978
0
510(k) clearances
55
Adverse events (1 deaths)
7
Recalls
56
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
| Date | Firm | Reason |
|---|---|---|
| 2025-12-04 | Merit Medical Systems, Inc. | Inflation device handle may detach from the syringe during procedure. |
| 2025-08-05 | Boston Scientific Corporation | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determine |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. |
| 2024-08-19 | Merit Medical Systems, Inc. | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. |
| 2021-06-10 | Merit Medical Systems, Inc. | Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. |
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Get your free API keyRead the docsData 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.