Recall Z-0057-2025— Merit Medical Systems, Inc.

Name: FDA recall Z-0057-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-30

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2024-08-30. It names one FDA 510(k) clearance: K011811. Product: Monarch Inflation Device 30 atm/bar REF IN2130 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.. Reason: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-30
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K011811 — MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGEMerit Medical Systems, Inc.·cleared 2001-08-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Monarch Inflation Device 30 atm/bar REF IN2130 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.

Reason for recall

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Data sourced from openFDA. This site is unofficial and independent of the FDA.