The Recall Desk
HighFDA (Devices)·Z-1346-2023·Announced 2023-04-12

Terumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding

Terumo Cardiovascular is recalling CAPIOX NX19 oxygenators with improperly bonded arterial thermistors that may leak. Eighty-four units were 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 recall of a risk-of-harm device used in critical cardiac bypass procedures. Meets rubric Score 3 criterion: risk-of-harm product where injury has not yet been reported.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling certain CAPIOX NX19 Hollow Fiber Oxygenator units, Catalog Number 3CX*NX19RE, Lot Number AM03. These devices contain an arterial thermistor component that is improperly bonded to the oxygenator port.

The improper bonding may result in a leak at the point where the arterial thermistor connects to the oxygenator port. The CAPIOX NX19 is a hollow fiber oxygenator used in cardiac bypass procedures to provide oxygenation and carbon dioxide removal during heart surgery. This recall affects 84 units that were distributed nationwide in the United States and to facilities in Belgium, Canada, Costa Rica, and Thailand.

The recalled product

Product
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiac Bypass Oxygenator
Hazard
  • improper-bonding
  • potential-leak

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 (2)

  • UDI-DI: (01)00699753450868
  • Lot Number AM03

Distribution

Distributed nationwide across the United States.

Related recalls

Same category