Aspira Valve Repair Kit may fail to open and obstruct fluid drainage
Merit Medical Systems is recalling Aspira Valve Repair Kits because valve assemblies may fail to open, preventing fluid drainage. The FDA Class II recall affects 2,559 units distributed across the US and internationally.
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: FDA Class II medical device where valve assemblies may fail to open and obstruct fluid drainage. No illnesses or injuries have been reported. This represents a risk-of-harm product where the hazard is potential rather than confirmed.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Aspira Valve Repair Kit, model REF 4992306 Version A (sterile, EO-sterilized). This is a prescription medical device used in valve repair procedures.
The recall was initiated because valve assemblies in affected units have the potential to not open properly, preventing fluid from draining. This is an FDA Class II medical device recall.
Approximately 2,559 units have been distributed worldwide, including throughout the United States (all 50 states plus Washington, DC and Puerto Rico), France, the United Kingdom, and Mexico. Affected lot numbers are I2604364, I2604393, I2587036, I2564649, I2558681, I2604394, I2609065, I2623156, and I2577984 (UDI-DI: 00884450394960).
No illnesses or injuries related to this defect have been reported. Healthcare providers should verify lot numbers and contact Merit Medical Systems for guidance on affected units.
The recalled product
- Product
- Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Valve Repair
- Affected units
- 2,559
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot # I2604364
- I2604393
- I2587036
- I2564649
- I2558681
- I2604394
- I2609065
- I2623156
- I2577984
- UDI-DI: 00884450394960
Distribution
Part of a larger recall action
This product is one of 13 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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