The Recall Desk
HighFDA (Devices)·Z-0059-2025·Announced 2024-10-23

Monarch Inflation Device Recalled Due to Sterile Barrier Breaches

Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.

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: This is a Class II medical device recall with no reported illnesses or injuries. The hazard—sterile barrier breaches from manufacturing defects—represents a risk of harm in a high-risk cardiac intervention context, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Merit Medical Systems, Inc. is recalling 1,120 Monarch Inflation Device 30 ATM/Bar units (Model MAP302, Catalog Number IN2330/B) due to a manufacturing process defect that creates holes and breaches in the Tyvek sterile barrier.

The Monarch Inflation Device is used in cardiac catheterization procedures to inflate and deflate balloon angioplasty catheters and to measure pressure within the balloon. A compromised sterile barrier could potentially expose patients to contamination during these invasive cardiac procedures.

The affected devices were distributed worldwide, including throughout the United States and to Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, and the United Kingdom. The following lot numbers are affected: H2369557, H2416390, H2421992, H2426112, H2492843, H2522880, H2540015, H2554505, H2560208, H2579556, H2765640, H2793109, H2806018, and H2810777.

Healthcare facilities and providers using these devices should immediately stop use of the affected lots and contact Merit Medical Systems for replacement units. Patients who may have received treatment with these devices should consult with their healthcare provider if they have any concerns.

The recalled product

Product
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measur
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Cardiac Catheterization Equipment
Hazard
  • sterile-barrier-breach
  • contamination-risk

Distribution

Distributed nationwide across the United States.

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