Monarch Inflation Device Recalled Due to Sterile Barrier Manufacturing Defect
Merit Medical Systems recalls 110,650 Monarch Inflation Devices due to manufacturing defects that create holes in the sterile barrier. The devices are used in cardiovascular procedures and may pose contamination risk.
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: This is an FDA Class II medical device recall involving defects in the sterile barrier of an invasive cardiovascular procedure device. While no illnesses or injuries have been reported, the compromise of sterile integrity on invasive medical devices poses a risk of harm through potential contamination.
Plain-English summary
Merit Medical Systems is recalling approximately 110,650 Monarch Inflation Devices (Model IN2130) used in cardiovascular procedures. These syringes are designed to inflate and deflate balloon angioplasty catheters, measure balloon pressure, and inject fluids while monitoring pressure during medical procedures.
The recall is due to a manufacturing defect that results in holes or breaches in the Tyvek sterile barrier. These defects compromise the sterile integrity of the devices, which could increase the risk of contamination during use in invasive procedures.
The affected devices were distributed worldwide to hospitals and medical facilities in the United States and internationally, including in Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, and the United Kingdom. Specific lot numbers have been identified by the manufacturer.
Facilities and healthcare providers in possession of affected devices should stop using them and contact Merit Medical Systems regarding replacement or return. Patients who may have received procedures using affected devices should consult with their healthcare provider.
The recalled product
- Product
- Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Angioplasty
- Affected units
- 110,650
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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