Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 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 also used to inject fluids into the body and to monitor the pressure of that fluid.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: IN2330/B UDI-DI code: 00884450298046 Lot Number: H2369557 H2416390 H2421992 H2426112 H2492843 H2522880 H2540015 H2554505 H2560208 H2579556 H2765640 H2793109 H2806018 H2810777
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Merit Medical Systems, Inc.
- Reason for Recall:
- Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 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 also used to inject fluids into the body and to monitor the pressure of that fluid.
Product Codes/Lot Numbers:
Catalog Number: IN2330/B UDI-DI code: 00884450298046 Lot Number: H2369557 H2416390 H2421992 H2426112 H2492843 H2522880 H2540015 H2554505 H2560208 H2579556 H2765640 H2793109 H2806018 H2810777
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0059-2025
Related Recalls
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
Merit Medical Systems
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.