Monarch Balloon Angioplasty Syringes Recalled Due to Sterile Barrier Defects
Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a manufacturing defect creating holes and breaches in the sterile barrier of medical syringes used in critical cardiovascular procedures. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not been reported, receiving a score of 3 (High). No illnesses or injuries are mentioned in the source material.
Plain-English summary
Merit Medical Systems is recalling Monarch 30 ATM syringes (Catalog Number K05T-2159) due to a manufacturing process resulting in holes and breaches in the Tyvek sterile barrier. A total of 432 devices are affected.
The recalled syringes are used to inflate and deflate balloon angioplasty catheters, to measure pressure within the balloon during cardiovascular procedures, and to inject fluids into the body while monitoring fluid pressure. The affected syringes were distributed worldwide to multiple countries including Canada, France, Japan, United Kingdom, and others, as well as throughout the United States.
The affected lot numbers are: T2417859, T2434208, T2509792, T2549931, T2561788, T2625814, T2675576, T2762716, T2801089, and T2893877. For information regarding this recall, contact Merit Medical Systems or the FDA.
The recalled product
- Product
- Melrose Wakefield Hospital REF K05T-2159 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…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 432
Distribution
Part of a larger recall action
This product is one of 6 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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