Z-1690-2015Class II

HLS/HIT Set Advanced with Bioline and/or Softline Coating Console

Name: Z-1690-2015 HLS/HIT Set Advanced with Bioline and/or Softline Coating Console
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 HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT... 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-1690-2015
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: HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support.
Product code: DTQ Console, Heart-Lung Machine, 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 BEQ-HLS 5050, 70105,2797, BEQ-HLS 7050, 70105.2794, and BO-HLS 7050, 70105.2786

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1690-2015
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 DTQ

K102726Class IICardiohelp SystemMaquet Cardiopulmonary, AG / cleared 2011-04-04

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)