Merit Medical Recalls Monarch Inflation Devices Due to Sterile Barrier Breaches
Merit Medical Systems is recalling 41,411 Monarch Inflation Devices because manufacturing defects caused holes in the sterile barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a medical device with a compromised sterile barrier, which presents a risk of infection or harm during invasive procedures. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Merit Medical Systems, Inc. is recalling 41,411 units of the Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque Device (Catalog Number IN2230/B). The device is used to inflate and deflate balloon angioplasty catheters, measure pressure, and inject fluids during medical procedures.
The recall was initiated due to a manufacturing process that resulted in holes or breaches in the Tyvek sterile barrier. This defect compromises the sterility of the device, which is critical for its intended use in invasive medical procedures.
The affected devices were distributed worldwide, including nationwide in the United States and in Belgium, Canada, France, Japan, Monaco, the Netherlands, Qatar, the United Arab Emirates, and the United Kingdom. Users should stop using the affected devices and contact Merit Medical Systems for further instructions.
The recalled product
- Product
- Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 41,411
Distribution
Part of a larger recall action
This product is one of 6 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.
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