Home › Nipro Vascular Innovations Americas, Inc. › GM-30 Inflation Device

GM-30 Inflation Device

Nipro Vascular Innovations Americas, Inc. · Model GM-30N · UDI-DI 04543660022648

PTM Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

30atm-25cc Inflation Device. Features standard length, 31 cm, high pressure tubing and 3 position stopcock for angioplasty balloon inflation and deflation. Indications for Use: 1. This device is recommended for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate 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Systems, Inc.	Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

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 key Read 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.