The Recall Desk
HighFDA (Devices)·Z-1913-2023·Announced 2023-06-21

Aspira Pleural Drainage Catheter May Fail to Drain Fluid

Merit Medical Systems is recalling 524 units of the Aspira Pleural Drainage Catheter Insertion Tray due to a defect where valve assemblies may not open, preventing fluid drainage. Affected units were distributed worldwide including across the US, France, UK, and Mexico.

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: This is an FDA Class II recall of a medical device with a functional defect that prevents normal operation. While no illnesses or injuries have been reported, the hazard—inability to drain fluid from a pleural catheter—poses a risk of serious harm in a critical medical context. Per the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.

Plain-English summary

Merit Medical Systems, Inc. is recalling the Aspira Pleural Drainage Catheter Insertion Tray 15.5F (Reference 4992507, Version A). The recall affects 524 units with lot numbers I2548172, I2568218, I2553914, I2614174, I2638785, and I2559299.

The device has a potential defect in its valve assemblies. Specifically, the valve assemblies may not open properly, which prevents fluid from draining through the catheter.

These catheter insertion trays were distributed worldwide to healthcare facilities in the United States (all states), France, United Kingdom, Mexico, and Puerto Rico.

Healthcare providers who have received these devices should stop using the affected lot numbers immediately. Facilities should check their inventory and contact Merit Medical Systems for information on replacement or return of the recalled units.

The recalled product

Product
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Surgical Drainage Equipment
Hazard
Affected units
524

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 (7)

  • Lot # I2548172
  • I2568218
  • I2553914
  • I2614174
  • I2638785
  • I2559299
  • UDI-DI: 00884450394915

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 malfunction

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