The Recall Desk
HighFDA (Devices)·Z-1345-2023·Announced 2023-04-12

CAPIOX RX15 Oxygenator units recalled due to improper thermistor bonding

Terumo is recalling CAPIOX RX15 Hollow Fiber Oxygenators due to improper bonding of the arterial thermistor, which may cause leaks at the connection port.

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 Class II medical device recall affects a critical-use product (oxygenator used in cardiovascular surgery). The improper thermistor bonding poses a potential leak hazard during use, with no illnesses or injuries reported to date.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling the CAPIOX RX15 Hollow Fiber Oxygenator (Catalog Number 3CX*RX15RE30, Lot 2M10). A total of 1412 units were affected.

The arterial thermistor component on some units may be improperly bonded to the oxygenator port. This improper bonding may result in a leak at the point where the thermistor connects to the port.

These oxygenators are used in cardiovascular perfusion systems during cardiac surgery and extracorporeal circulation procedures. The affected units were distributed in the United States nationwide as well as Belgium, Canada, Costa Rica, and Thailand.

Healthcare facilities and providers who have received these oxygenators should contact the manufacturer for guidance. Patients should inform their healthcare providers if they received treatment with equipment from this lot.

The recalled product

Product
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiovascular Oxygenator
Hazard
  • improper-bonding
  • leak-hazard

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)00699753450134
  • Lot Number: 2M10

Distribution

Distributed nationwide across the United States.

Related recalls

Same category