FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
- Recall number
- Z-1346-2023
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
- Status
- Open, Classified
- Initiated
- 2023-03-01
- Posted
- 2023-04-05
- Terminated
- not on file
- Reason
- Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
- Root cause
- Process control
- Action
- An URGENT MEDICAL DEVICE RECALL notification letter dated 3/1/23 was sent to customers. RECOMMENDED ACTIONS Terumo CVS advises users to remove all affected product from inventory and return unused product to Terumo CVS following the instructions provided in this notice. Terumo CVS will credit the user s accounts for returned, unused products. AFFECTED POPULATION The affected population is all patients on which an impacted Capiox NX, RX or FX Oxygenator is used. CUSTOMER INSTRUCTIONS - Review this Medical Device Recall notice and ensure that all users receive notice of this issue. Refer to the Customer Response Form to identify your product inventory that is subject to this action. Confirm receipt of this communication by completing and returning the attached Customer Response Form to the email address or fax number indicated on the form. Please return the Customer Response Form even if you no longer have the affected product in inventory. If the affected product has been distributed to another user or location, please forward a copy of the notice as needed. Terumo CVS will issue a Return Goods Authorization upon receipt of the Customer Response Form. Return all affected products to Terumo CVS. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET Terumo Recall Fax: 443-993-5738 or emailing 4439935738@efax.com Terumo Recall Email: TCVSCustomerResponseElkton@terumomedical.com
- Quantity
- 84 units
- Distribution
- US Nationwide. Belgium, Canada, Costa Rica, Thailand.
- Lot, serial or model codes
- UDI-DI: (01)00699753450868; Lot Number AM03
- 510(k) numbers
- ["K180950"]
- PMA numbers
- not on file
- Product code
- DTZ
- Firm FEI
- 3000204839
- Firm city
- Elkton
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28