Z-1053-2024Class II

Bubble Sensor (REF: 70105.5720)

Name: Z-1053-2024 Bubble Sensor (REF: 70105.5720)
Creator: Maquet Medical Systems USA
Published: 2023-12-28
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2023-12-28 / Open, Classified / root cause: labeling and UDI

FDA source

Maquet Medical Systems USA began a recall of Bubble Sensor (REF: 70105.5720) on 2023-12-28. FDA classified it as Class II and gives the reason as "The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1053-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-28
Posted: 2024-02-08
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Bubble Sensor (REF: 70105.5720)
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: An Urgent Medical Device Correction Letter was sent VIA Fed-Ex 2-day delivery with signature proof of delivery to all consignees with the following instructions: Actions to be taken by the Customer: - Please examine your inventory immediately to determine if you have any affected product in your inventory. - Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE - CORRECTION RESPONSE FORM 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 1-866-416-5299. - Affected Bubble Sensors do not need to be returned and can be used as-is. - Please forward this information to all current and potential Bubble Sensor 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. If you have any questions, please contact your Getinge representative or call Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in commerce: 274 units (70 US, 204 OUS)
Distribution: AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.
Product codes and lots: Model: BS 3/8x3/32 L1.7; Correct UDI DI: 04037691816432; Incorrect UDI DI (as labeled): 04058863025148; SNs: 90041799 90041816 90041938 90042009 90042069 90041802 90041817 90041939 90042011 90042070 90041804 90041818 90041940 90042036 90042071 90041805 90041821 90041943 90042037 90042074 90041806 90041822 90041957 90042038 90042076 90041807 90041823 90041963 90042042 90042079 90041808 90041826 90041966 90042049 90042083 90041809 90041836 90041974 90042050 90042085 90041810 90041898 90041983 90042054 90042089 90041811 90041905 90041993 90042056 90042090 90041812 90041907 90041994 90042058 90042092 90041813 90041921 90041995 90042060 90042093 90041814 90041925 90041997 90042063 90042094 90041815 90041930 90042005 90042066 90042097;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1053-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1053-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-08

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)