Home › BALT USA LLC › Magic Infusion Catheter

Magic Infusion Catheter

BALT USA LLC · Model MAGIC1.2FM180 · UDI-DI 00818053022609

KRA Prescription

510(k) clearances

9,056

Adverse events (362 deaths)

Recalls

148

Facilities

Description

Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into selected vessels in the neurovasculature. Magic Infusion Catheters are intended to facilitate access through distant, tortuous vasculature. Progressive suppleness ranging from a highly flexible tip to a semi-rigid proximal section allows the catheter to be advanced by the physician. It is not intended for use in the coronary vasculature.

Recalls

Date	Firm	Reason
2023-12-18	Angiodynamics, Inc.	Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
2023-11-06	Merit Medical Systems, Inc.	The sterility of microcatheter and infusion system devices cannot be guaranteed.
2022-06-30	Micro Therapeutics, Inc.	Outer carton packaging of microcatheters were exposed to wet substance during transport.
2022-06-30	Micro Therapeutics, Inc.	Outer carton packaging of microcatheters were exposed to wet substance during transport.
2020-11-03	Boston Scientific Corporation	This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2019-11-08	Cook Inc.	A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa
2017-11-09	Vascular Insights, LLC	Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction

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.