The Recall Desk
HighFDA (Devices)·Z-1916-2023·Announced 2023-06-21

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.

What this means for you

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
Hazard
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

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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.

See all 13 products in this recall →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

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Same hazard · valve failure

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