The Recall Desk
HighFDA (Devices)·Z-0629-2024·Announced 2024-01-10

Microcatheter and Infusion Systems Recalled Due to Sterility Concerns

Merit Medical Systems is recalling specific lots of microcatheter and infusion system devices because their sterility cannot be guaranteed. The devices were distributed worldwide including multiple US states and international locations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of sterile-critical medical devices where sterility cannot be guaranteed. No illnesses or injuries have been reported, but the risk of serious infection from non-sterile invasive devices represents a high-risk situation where harm has not yet been documented.

Plain-English summary

Merit Medical Systems, Inc. is recalling Fountain microcatheter and infusion system devices (model references IS4-135-30 and IS4-90-10) because the sterility of these devices cannot be guaranteed. These are prescription-only medical devices used in clinical procedures.

The recall affects devices distributed worldwide. In the United States, distribution included the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Utah, and Wisconsin. Internationally, devices were distributed to Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, the Netherlands, and Switzerland. Affected lots are H2765720 (IS4-135-30) and H2765603 (IS4-90-10).

Healthcare facilities and medical professionals should contact Merit Medical Systems regarding return or replacement instructions. Patients who have received these devices should speak with their healthcare provider about the recall and any necessary follow-up care.

The recalled product

Product
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Cardiovascular / Infusion Systems
Hazard
Affected units
3

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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Same manufacturer · Merit Medical Systems, Inc.

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Same hazard · sterility failure

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