Monarch Inflation Device Syringe Recalled for Sterile Barrier Defect
Merit Medical Systems is recalling 51,900 Monarch Inflation Device syringes due to manufacturing defects causing breaches in the sterile barrier. The devices are used in balloon angioplasty procedures. No injuries have been reported.
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 FDA Class II recall affects a risk-of-harm product (an invasive cardiovascular medical device) where a manufacturing defect compromises the critical sterile barrier. Although no illnesses or injuries have been reported, the inherent risk of infection from sterile barrier breaches in this device class, combined with the FDA's Class II classification, warrants a High severity rating.
Plain-English summary
The Monarch Inflation Device syringe (30 atm/bar MAP152, Catalog Number IN2530/B) is a medical device used to inflate and deflate balloon angioplasty catheters and to measure pressure during cardiovascular procedures. It is also used to inject fluids into the body and monitor fluid pressure.
Merit Medical Systems is recalling 51,900 units worldwide due to a manufacturing process that has resulted in holes and breaches in the Tyvek sterile barrier. The sterile barrier is essential to preventing contamination during use in invasive cardiovascular procedures.
The recall affects devices distributed nationwide in the United States and internationally to Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, and the United Kingdom. Affected lot numbers range from H2305037 through H3009570.
Healthcare facilities and practitioners should stop use of affected devices and contact Merit Medical Systems for return or replacement instructions. No injuries or illnesses have been reported in association with this recall to date.
The recalled product
- Product
- Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty cathete
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- sterile-barrier-breach
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
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