Monarch Inflation Devices Recalled for Sterile Barrier Defects
Merit Medical Systems is recalling approximately 6,565 Monarch Inflation Devices due to manufacturing defects that compromise the sterile barrier, potentially allowing device contamination.
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: FDA Class II recall of a device used in invasive procedures. Sterile barrier defect creates potential for device contamination. No illnesses or injuries have been reported, making the hazard theoretical. Per the rubric, theoretical hazards without reported injuries score at most 3 (High).
Plain-English summary
The Monarch Inflation Device 30 atm/bar (Catalog Number IN2430/B) is a medical device manufactured by Merit Medical Systems, Inc. It is used to inflate and deflate balloon angioplasty catheters and measure pressure during cardiovascular procedures. Approximately 6,565 units are affected by this recall.
The devices have been recalled due to holes and breaches in the Tyvek sterile barrier caused by a manufacturing process defect. A sterile barrier is essential to maintain device sterility before use. A compromised sterile barrier may allow the device to become contaminated.
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. Patients, healthcare providers, and facilities that have received affected devices should stop using them immediately and contact Merit Medical Systems for instructions regarding return, replacement, or disposal.
The recalled product
- Product
- Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 6,565
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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