Z-1689-2015Class II

Quadrox-iD Adult Diffusion Membrane Oxygenator

Name: Z-1689-2015 Quadrox-iD Adult Diffusion Membrane Oxygenator
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2015-03-05
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2015-03-05 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal... on 2015-03-05. FDA classified it as Class II and gives the reason as "A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1689-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-05
Posted: 2015-05-28
Terminated: 2019-01-18
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Maquet sent a "Field Safety Notice" accompanied by a Response Form to their affected customers on 3/5/2015 via FedEx. The Field Safety Notice identified the affected products/Part numbers and actions to be taken by the user. The customers were asked to complete the Field Safety Notice Response Form to acknowledge that they have received the notice. The completed notice can be faxed to 1-973-396-3607 or sent via email to [email protected]. For any questions, customers can contact their Maquet Sales Representative or Maquet Customer Service at 1-888-627-8383 (press option 2, followed by option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.
Quantity in commerce: 10,199 units
Distribution: Worldwide Distribution - US Nationwide and the countries of: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, South Korea, Latvia, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia Montenegro, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and Uruguay
Product codes and lots: Part numbers BO-HMOD 70000, 70105.3815, BEQ-HMOD 70000, 70105,3824

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1689-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1689-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-28
Z-1690-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-28

Product code DTZ

K132829Class IIQuadrox-I, Quadrox-Id, Quadrox-Ir OxygenatorsMaquet Cardiopulmonary, AG / cleared 2013-10-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)