Z-1300-2026Class II

Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720

Name: Z-1300-2026 Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720
Creator: Maquet Cardiopulmonary Gmbh
Published: 2026-01-09
License: https://open.fda.gov/license/

MAQUET CARDIOPULMONARY GmbH / initiated 2026-01-09 / Open, Classified

FDA source

Maquet Cardiopulmonary Gmbh began a recall of Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720 on 2026-01-09. FDA classified it as Class II and gives the reason as "Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1300-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-09
Posted: 2026-02-05
Recalling firm: MAQUET CARDIOPULMONARY GmbH
Product: Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
FDA root cause: Under Investigation by firm
Action: On or around January 9, 2026, "URGENT MEDICAL DEVICE RECALL" letters were sent to customers. Customers were instructed to take the following actions: - Please examine your inventory immediately to determine if you have any affected product in your inventory and utilize the recommended mitigations listed above until replacement sensors are available. - Complete and return the enclosed response form Getinge by e-mailing a copy to [email protected]. - Contact Customer Service via email at [email protected] or 888-943-8872, ext 28849 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone) to order a replacement sensor that will be shipped once available. Affected sensors will be returned to Getinge at time of replacement. - Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. If you have any questions, contact Customer Service via email at [email protected] or 888-943-8872, ext 28849 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone).
Quantity in commerce: 3050 units
Distribution: Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of (South Korea), Latvia, Lithuania, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, and Vietnam
Product codes and lots: Model Number: 701055720; UDI-DI: 04037691816432; Serial Numbers: All units impacted;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1300-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1300-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05

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)