Z-0290-2024Class II

Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i)...

Name: Z-0290-2024 Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i)...
Creator: Maquet Medical Systems USA
Published: 2023-10-12
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2023-10-12 / Open, Classified / root cause: design

FDA source

Maquet Medical Systems USA began a recall of Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder) on 2023-10-12. FDA classified it as Class II and gives the reason as "It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0290-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-12
Posted: 2023-11-09
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.
Root cause tag: design
FDA root cause: Device Design
Action: An URGENT MEDICAL DEVICE Correction notification letter dated 10/12/23 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received a CARDIOHELP-i System having a serial number that is affected by this voluntary Medical Device Correction. " Please examine your inventory immediately to determine if you have any affected CARDIOHELP System(s) in your inventory. " Should you have any affected CARDIOHELP-i System(s), your unit(s) will need to be returned to Getinge for correction. Getinge will contact your facility to arrange the return of your unit for correction. A CARDIOHELP loaner can be provided if needed. " Please do not to fixate any accessory at the slide rail until the slide rail holders have been replaced. " Affected CARDIOHELP-i can be used for intra-hospital transport only when placed on a Sprinter cart. " Inter-hospital transport is not permitted until the slide rail holders have been replaced. " Please forward this information to all current and potential CARDIOHELP-i users within your hospital / facility. " If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. " Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE- CORRECTION RESPONSE FORM (Page 4) to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1-866-313-4049. Type of Action by Getinge: A Getinge representative will contact you to arrange for the repair of your CARDIOHELP -i unit(s). Getinge will correct your CARDIOHELP -i unit(s) upon receipt and will return your unit(s) once correction has been completed. This voluntary correction only affects the products listed on Page 1; no other products are affected by this voluntary correction. We apologize for
Quantity in commerce: 1022 units
Distribution: US Nationwide.
Product codes and lots: UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0290-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0290-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09

Product code DTQ

K133598Class IICardiohelp SystemMaquet Cardiopulmonary, AG / cleared 2014-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)