Merit Medical recalls 30 atm/bar Monarch Inflation Device with Tyvek barrier holes that could allow infection during medical procedures. Affected units have specific lot numbers and were sold in the U.S. from 2022 to 2023.
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Merit Medical is recalling its Monarch Inflation Device 30 atm/bar for potential holes in the Tyvek sterile barrier. This could allow bacteria to enter during medical procedures, risking infection for patients.
The Tyvek sterile barrier has manufacturing defects that create holes. These holes could allow bacteria to enter the body during medical procedures, increasing infection risk.
Patients undergoing angioplasty procedures using the recalled device are at risk of infection. Healthcare providers using the device for balloon inflation may also face infection risks.
Check for the product name 'Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430'. Affected units have specific lot numbers listed in the recall notice.
Look for lot numbers H2298615 through H2599815 in the product's documentation.
Reach out to Merit Medical Systems for guidance on next steps if you have the recalled device.
Yes, this device is used to inflate and deflate balloon angioplasty catheters and to inject fluids during medical procedures.
Affected units have lot numbers from H2298615 to H2599815 as listed in the recall notice.
Check for the product name 'Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430' and the specific lot numbers listed.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0060-2025 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-0060-2025 from Merit Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
