The Recall Desk
HighFDA (Devices)·Z-1347-2023·Announced 2023-04-12

CAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding

Terumo Cardiovascular Systems is recalling 4,940 CAPIOX FX25 oxygenators because an arterial thermistor component may be improperly bonded to the oxygenator port, potentially causing leaks.

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 involving a cardiac bypass device with a potential leak hazard from improper component bonding. No injuries or deaths have been reported in the source material. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High (3) severity score.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 4,940 units of the CAPIOX FX25 Hollow Fiber Oxygenator (catalog numbers 3CX*FX25REC and 3CX*FX25RWC, lot number AM03) due to a manufacturing defect.

Some units in this recall may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This defect can result in a leak at the point where the thermistor is bonded.

The affected products were distributed in the United States and internationally to Belgium, Canada, Costa Rica, and Thailand. Healthcare facilities using this equipment should check their inventory against the recalled catalog numbers and lot number.

If your facility has received affected units, contact Terumo Cardiovascular Systems Corporation immediately for instructions on return or replacement of the recalled oxygenators.

The recalled product

Product
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiac Bypass Equipment
Hazard
Affected units
4,940

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.

Part of a larger recall action

This product is one of 3 recalled by Terumo Cardiovascular Systems Corporation 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 3 products in this recall →

Related recalls

Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · improper bonding

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