HLS Set BEQ-HLS 5050 USARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04058863076355), received between Aug 13, 2024 and Jun 11, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

3 FDA recall records name this device's identifier, 3 still open.

9 other recalls cover devices cleared under the same FDA submission (K112360); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

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

2. 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 · FDA record ↗

3. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 9, 2025Partial Blockage; Fluid/Blood Leak; Partial Blockage; Fluid/Blood Leak

  COMPLAINT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756333 ↗
• MalfunctionOct 1, 2024Partial Blockage; Fluid/Blood Leak; Partial Blockage; Fluid/Blood Leak

  COMPLAINT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342572 ↗
• MalfunctionAug 13, 2024Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER IS TRIALING A NEW HEATER WITH THE ECMO DEVICES. THE NEW HEATERS (NOT A GETINGE PRODUCT) ARE CLEANED WITH VIREX PLUS. THE CHEMICAL IS RINSED OUT DURING THE CLEANING CYCLE, BUT ONE OF THE HEATERS APPEARED TO HAVE SOME VIREX PLUS STILL PRESENT. THIS WAS DISCOVERED ONCE PLACED ON A PATIENT, WHEN FOAM WAS DISCOVERED COMING OUT OF THE GAS OUTLET OF THE HLS MODULE. THERE IS NO HARM TO THE PATIENT. THE CUSTOMER IS PLANNING ON CHANGING THE HLS SET. AFTER THAT EVENT THE CUSTOMER IS ALSO PLANNING TO SWITCH TO ISOPROPYL ALCOHOL FOR THE CLEANING AGENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. ON 2024-08-08 THE INFORMATION WAS RECEIVED THAT THE HLS SET WAS EXCHANGED 36 HOURS LATER AS EXCESSIVE FLUID CONTINUED TO DROP FROM THE GAS OUTLET EVEN AFTER THE FOAM CEASED. THE FOAM WAS CLEARED AFTER 30 MINUTES. THIS WAS MITIGATED BY CHANGING THE HEATER DEVICE. AS THE FAILURE OCCURRED DURING TREATMENT, AND THE DEVICE WAS EXCHANGED THE EVENT REPRESENTS A RISK FOR THE PATIENT, THEREFORE A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972392 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112360. One submission often covers many models, so check the product and lot details in each record.

• Z-1077-2024 · Jan 16, 2024 · Open, Classified
  BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
• Z-1764-2022 · Jul 22, 2022 · Open, Classified
  BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP Sy
• Z-1767-2022 · Jul 22, 2022 · Open, Classified
  BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP Sy
• Z-1765-2022 · Jul 22, 2022 · Open, Classified
  BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP Sy
• Z-0632-2021 · Nov 20, 2020 · Terminated
  HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in orde
• Z-0633-2021 · Nov 20, 2020 · Terminated
  HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to
• Z-2149-2019 · Jul 11, 2019 · Terminated
  Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
• Z-2262-2013 · Aug 15, 2013 · Terminated
  QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracor
• Z-0160-2013 · Jun 12, 2012 · Terminated
  QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for