Merit Medical recalls Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device due to holes in the Tyvek sterile barrier that could allow infection during medical procedures.
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 the body during medical procedures, increasing infection risk.
The device's Tyvek sterile barrier has manufacturing defects causing holes or breaches. These holes could allow bacteria to enter the body during medical procedures, increasing infection risk. The device is used to inflate balloon catheters and inject fluids in procedures like angioplasty.
Healthcare professionals using this device for angioplasty procedures are most at risk. Patients undergoing procedures with this device could face infection if the barrier is compromised.
Check for the product name 'Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device' with catalog number IN2530. Look for lot numbers listed in the recall notice.
Inspect the Tyvek sterile barrier for holes or breaches before use. If holes are present, stop using the device immediately.
Reach out to Merit Medical Systems for specific instructions on how to return or replace the device if it's affected.
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device.
Check for the catalog number IN2530 and lot numbers listed in the recall notice (e.g., H2305037, H2309345, etc.).
The recall is due to potential holes in the Tyvek barrier that could allow infection, not direct injury risks like cuts or fires.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0061-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0061-2025 from Merit Medical. 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.
