Merit Medical recalls Monarch Inflation Device 30 atm/bar REF IN2130 with holes in sterile Tyvek barrier that could cause infection during 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 REF IN2130 syringe and balloon inflation system because manufacturing defects created holes in the Tyvek sterile barrier. This could allow contaminants to enter the device during medical procedures, increasing infection risk for patients.
The device's Tyvek sterile barrier has manufacturing defects that create holes. These holes could allow contaminants to enter the device during medical procedures, potentially causing infections in patients.
Patients using this device for angioplasty procedures or fluid injections. Healthcare providers using the device in medical settings are most at risk.
Check for the catalog number IN2130 or JPB, UDI-DI code 00884450298022, and lot numbers listed in the recall notice. The device is used for inflating balloon angioplasty catheters and measuring pressure during procedures.
Identify the catalog number (IN2130 or JPB), UDI-DI code (00884450298022), and lot numbers from the recall list.
Due to manufacturing defects that create holes in the Tyvek sterile barrier, which could allow contaminants to enter during medical procedures.
The recall notice does not specify a remedy or action for affected devices. Check the official recall list for lot numbers and catalog numbers.
The recall states the hazard could cause infection, but no specific risk of serious injury is mentioned. The danger level is low_risk.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0057-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0057-2025 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.
