CLASS II Device recall · Reported 3 Jun 2015 · FDA Enforcement Report

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

Maquet Cardiovascular Us Sales is recalling HLS/HIT Set Advanced with Bioline and/or Softline Coating Console, distributed nationwide in the US. The recall was initiated on 5 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart numbers BEQ-HLS 5050, 70105,2797, BEQ-HLS 7050, 70105.2794, and BO-HLS 7050, 70105.2786

Quantity recalled10, 199 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1690-2015
FDA event ID: 70681
Recalling firm: Maquet Cardiovascular Us Sales, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 5 Mar 2015
FDA classified: 28 May 2015
Reported: 3 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

5 Mar 2015	Recall initiated by company
28 May 2015	Classified by FDA	+84 days
3 Jun 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Part numbers BEQ-HLS 5050, 70105,2797, BEQ-HLS 7050, 70105.2794, and BO-HLS 7050, 70105.2786

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 70681

This product is part of a recall event; the main page for the event is Quadrox-iD Adult Diffusion Membrane Oxygenator recalled.

Reported	Class	Recall	Company	Reason	Where
3 Jun 2015	CLASS II	Quadrox-iD Adult Diffusion Membrane Oxygenator recalled	Maquet Cardiovascular Us Sales	Packaging Defects	Nationwide

More recalls from Maquet Cardiovascular Us Sales

All 62

Reported	Class	Recall	Company	Reason	Where
23 Dec 2020Device	CLASS II	HLS Set Advanced recalled by Maquet Cardiovascular Us Sales	Maquet Cardiovascular Us Sales	Sterility	Nationwide
23 Dec 2020Device	CLASS II	HLS Set Advanced recalled by Maquet Cardiovascular Us Sales	Maquet Cardiovascular Us Sales	Sterility	Nationwide
18 Nov 2020Device	CLASS II	Blood Monitoring Unit (BMU recalled by Maquet Cardiovascular Us Sales	Maquet Cardiovascular Us Sales	Temperature Abuse	Nationwide
28 Oct 2020Device	CLASS II	Yuno II Mobile Operating Table recalled	Maquet Cardiovascular Us Sales	Foreign Material	Nationwide
28 Oct 2020Device	CLASS II	Yuno Mobile Operating Table recalled by Maquet Cardiovascular Us Sales	Maquet Cardiovascular Us Sales	Foreign Material	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

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16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide