HLS SetRecalls & reported problems across all models

We found 2 models of HLS Set by Maquet Cardiopulmonary AG in the FDA's device registry (GUDID). Together they are named in 94 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2022 and Sep 28, 2026 — classified as 13 deaths, 11 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (29 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

HLS Set recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 16, 2024Open, Classified

   The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

   Z-1077-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jan 16, 2024Open, Classified

   The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

   Z-1076-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Feb 13, 2023Open, Classified

   Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.

   Z-1188-2023 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

4. Jul 22, 2022Open, Classified

   The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

   Z-1767-2022 · Root cause: Package design/selection · Recall details · FDA record ↗

5. Jul 22, 2022Open, Classified

   The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).

   Z-1766-2022 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported HLS Set problems

HLS Set models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HLS Set BEQ-HLS 7050 USA

  Oxygenator, Cardiopulmonary Bypass
  3 recalls13 deaths90 reports
• HLS Set BEQ-HLS 5050 USA

  Oxygenator, Cardiopulmonary Bypass
  3 recalls4 reports

Recent HLS Set adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Pressure Problem

  The event occurred USA during priming. It was reported that the pressure was not functioning on the set. The HLS Set was replaced and pressures functioned as required. There was no patient involvement, as it was for pre-priming. No harm to any person has been reported. As a pressure reading issue can lead to a pump stop, if the intervention is set by the user, a report is required. Complaint ID: (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911845 ↗
• InjurySep 17, 2026Fluid/Blood Leak

  The event occurred in the United States. It was reported that an HLS Set was replaced during use due to a leak causing blood to continuously drip from the gas outlet. Due to the reported leakage during use and the exchange a report is required. Additional information was received on 2026-09-24 that a blood transfusion was required due to the reported leakage. Based on that the Adverse Event /Product Problem has been changed to Adverse Event. Complaint ID: (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800449 ↗
• InjuryAug 26, 2026Infusion or Flow Problem

  The event occurred in the US during patient treatment. It was reported that oxygenation issues with an HLS Set occurred during VA ECMO of a 37-year-old male patient who experienced acute decompensation following transport to the operating room. While using the HLS Set, the HLS tubing and blood observed pre- and post-oxygenator appeared dark blue despite sweep gas settings of 1 L/min at 100% oxygen. The clinical team noted that the patient may have been developing North-South Syndrome. Additionally, the patient was reportedly transported without a transport ventilator and was manually ventilated by the anesthesia team using a resuscitation bag. The exact ventilation rate during transport was unknown. The ECMO Manager indicated that inadequate ventilation during transport may have contributed to deoxygenation of the patient's upper body, particularly as the patient's cardiac output had increased prior to transport. The involved doctor suspected the HLS Set to be defective, the initial used HLS Set was subsequently replaced for a second HLS Set. Following the HLS Set exchange, the patient's oxygenation improved immediately. As the patient suffered a low oxygenation and the HLS Set was

  Patient problems: Low Oxygen Saturation

  MAUDE report 50450732 ↗
• InjuryAug 24, 2026Increase in Pressure

  The event occurred in the US. It was reported that on (b)(6) 2026 the customer cannulated a patient for VA. Customer were flowing a little over 3L approximately 10 minutes after initiation and the delta pressure was 26 then 5-10 minutes later it shot up to the 70 in the HLS Set. Immediately the customer grabbed another Cardiohelp to prepare it for a circuit change. By the time customer switched to the other HLS set, as the delta was in the 170s. After changing the circuit, we had no issues with the flow or the deltas. No harm to any person has been reported. On (b)(6) 2026, the SSU provided additional information regarding the reported event. An IABP and an Impella device were also in use during the procedure. No harm to the patient or operator was reported. The patient was experiencing cardiogenic shock and was receiving multiple vasopressors. The patient was cannulated for VA ECMO support and was being transferred to a VAD/transplant center for further evaluation. No pre-existing medical conditions were identified that could have influenced the reported event. No clots were observed. All pressures were zeroed while the set was free of liquids/priming solution. No visible defects

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50406727 ↗
• MalfunctionAug 19, 2026Pressure Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50319809 ↗
• MalfunctionAug 18, 2026Environmental Particulates; Priming Problem

  The event occurred in the US. It was reported that while priming a HLS Set a "foreign body" described as something that looked like a short hair was observed in the HLS Module. The device was then removed from the cardiohelp unit and never used on a patient. The HLS Set was saved, however the clinician drained the device for saving and, when doing that, the strand disappeared. No harm to any person has been reported. If a foreign object is not detected prior to use, it may enter the blood circulation during clinical use, which could be a risk to the patient; therefore, a report is required. Complaint ID: (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50295731 ↗
• MalfunctionAug 10, 2026Increase in Pressure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189564 ↗
• MalfunctionJul 29, 2026Pressure Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50064898 ↗
• MalfunctionJun 22, 2026Priming Problem

  THE EVENT OCCURRED IN THE USA PRIOR TO USE. IT WAS REPORTED THAT A FOREIGN OBJECT, A CLOUDY WHITE PARTICLE, WAS SEEN IN THE PRIMING BAG OF THE HLS SET. THE AFFECTED HLS SET WAS PRIMED ON (B)(6) 2026. THE PRIMING BAG WAS STORED ON SPRINTER CART IV POLE. THE PRIMING SOLUTION IS STORED IN CABINET IN ICU. THE CIRCUIT WAS PRIMED WITH PLASMA-LYTE A INJECTION PH 7.4 WITH TWO 1-LITER BAGS. A PORTION OF THE PLASMALYTE WAS STILL IN THE SECOND BAG ATTACHED TO THE CIRCUIT. ON (B)(6) 2026 THE CLOUDY OBJECT WAS NOTICED WITHIN THE PRIMING BAG. IT WAS CONFIRMED, THAT THERE WERE NOT ANY ENVIRONMENTAL CONDITIONS PRESENT AT THE TIME WHICH COULD HAVE INFLUENCED THE EVENT. THE AFFECTED PRODUCT WAS NOT USED ON A PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. IF A FOREIGN OBJECT IS NOT DETECTED PRIOR TO USE, IT MAY ENTER THE BLOOD CIRCULATION DURING CLINICAL USE, WHICH COULD BE A RISK TO THE PATIENT, THEREFORE A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25575886 ↗
• MalfunctionJun 19, 2026Pressure Problem

  THE EVENT OCCURRED IN ITALY DURING PRIMING PROCEDURE OF THE HLS SET. NO PATIENT WAS INVOLVED. IT WAS REPORTED THAT PRESSURE ISSUES REGARDING P INT OCCURRED. THE PRESSURES WERE ZEROED WITH FREE OF LIQUIDS. NO DEFECT WAS SEEN ON THE HLS SET. THE AFFECTED HLS SET WAS TESTED ON ANOTHER CARDIOHELP DEVICE AND HAD THE SAME PROBLEM. THE CARDIOHELP DEVICE WAS EXCLUDED AS FAULT. A NEW HLS SET WAS USED WITH THE FIRST CARDIOHELP DEVICE FOR THE PLANNED PATIENT TREATMENT. THERE WAS NO DELAY IN TREAMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS ANY PRESSURE ISSUE CAN LEAD TO A PUMP STOP DURING TREATMENT, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25559420 ↗
• MalfunctionJun 11, 2026Pressure Problem

  THE EVENT OCCURRED IN THE USA PRIOR TO USE ON (B)(6) 2026. IT WAS REPORTED THAT THE HLS SET HAD PRESSURE READING ISSUES AFTER SET-UP. P VEN COULD NOT BE READ, IT WAS DISPLAYED AS DASHES. THE AFFECTED HLS SET WAS PRIMED ON (B)(6) 2026. THE PRESSURES ZEROED WHILE THE SET WAS FREE OF LIQUIDS/PRIMING SOLUTION. NO VISIBLE DAMAGE WAS SEEN ON THE SENSOR HOUSING OR GREEN FLEXLINE. IN ORDER TO RECTIFY THE ISSUE, THE HLS CABLE WAS REPLACED. THE AFFECTED HLS SET WAS AS WELL CONNECTED TO A DIFFERENT CARDIOHELP DEVICE. HOWEVER, THE ISSUE COULD NOT BE SOLVED. THE CARDIOHELP DEVICES COULD BE EXCLUDED AS FAULT. THE AFFECTED HLS SET WAS NOT CONNECTED TO A PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUE CAN LEAD TO A PUMP STOP, IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467577 ↗
• MalfunctionJun 11, 2026Pressure Problem

  THE EVENT OCCURRED IN THE USA PRIOR TO USE. IT WAS REPORTED THAT WHILE ZEROING THE PRESSURES PVEN WAS NOT HAVING A VALUE DURING SET-UP. THE AFFECTED HLS SET WAS CONNECTED TO THREE CARDIOHELP DEVICES FOR TESTING. ON EVERY DEVICE NO VALUE FOR PVEN WAS SHOWN. THE CUSTOMER CONFIRMED, THAT THE CARDIOHELP CAN BE EXCLUDED AS FAULT. A NEW HLS SET WAS USED AND EVERYTHING WAS WORKING AS INTENDED. THERE WAS NO DELAY IN TREATMENT. DURING PRIMING OF THE HLS SET NO VISIBLE DAMAGE WAS NOTICED. FURTHER, ZEROING THE PRESSURES WAS PERFORMED, WHILE THE SET WAS FREE OF LIQUIDS/ PRIMING SOLUTION. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUE CAN LEAD TO A PUMP STOP, IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25467572 ↗
• MalfunctionJun 8, 2026Connection Problem

  COMPLAINT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427579 ↗
• MalfunctionMay 8, 2026Noise, Audible

  THE EVENT OCCURRED IN USA DURING TREATMENT. IT WAS REPORTED THAT AT 4200 RPMS A LOUD GRINDING NOISE WAS HEARD. THE CUSTOMER TEMPORARILY TURNED THE RPM DOWN BELOW 4000 RPM AND THE NOISE WENT AWAY. THE HLS SET WAS REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE HLS SET WAS REPLACED DURING TREATMENT, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25120147 ↗
• MalfunctionMay 4, 2026Pressure Problem

  THE EVENT OCCURRED IN THE USA. IT WAS REPORTED THAT THE VENOUS PRESSURE READING WAS UNRELIABLE. FURTHER, A CLICKING SOUND WAS HEARD WHEN THE SENSOR CABLE WAS MOVED TOWARDS THE HLS-SET CONNECTION. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUE CAN LEAD TO A PUMP STOP, IF THE INTERVENTION IS SET BY THE USER A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067533 ↗

Other Maquet Cardiopulmonary AG products

• MAQUET CARDIOHELP5 models · 173 reports · 9 recalls
• QUADROX-i10 models · 1 reports · 10 recalls
• ROTAFLOW4 models · 14 reports · 4 recalls
• QUADROX-iD3 models · 0 reports · 4 recalls