HLS Set BEQ-HLS 7050 USARecalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 04058863080383), received between Mar 2, 2022 and Sep 28, 2026 — classified as 13 deaths, 11 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (28 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 16, 2024Class IIOpen, 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. Feb 13, 2023Class IIOpen, 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 · Recall details · FDA record ↗

3. Jul 22, 2022Class IIOpen, 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 90 reports, 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. 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 ↗
• MalfunctionApr 10, 2026Temperature Problem

  THE EVENT OCCURRED IN THE US. INITIALLY, IT WAS REPORTED THAT A PATIENT INITIATED ON CARDIOHELP, THE ALARM ¿PART SENSOR DISCONNECTED¿ OCCURRED. CUSTOMER DECIDED TO SWAP THE HLS SET TO ANOTHER CARDIOHELP USING SAME HLS SET, THEN NO TART READING AND NO AUDIBLE ALARM. TART STARTED WORKING LATER ON. NO HARM TO ANY PERSON HAS BEEN REPORTED. NEW INFORMATION HAS BEEN PROVIDED BY THE SSU (SALES AND SERVICE UNIT) DATES ON 2026-03-30 THAT THERE WAS AN ERROR/CORRECTION IN ORIGINAL DESCRIPTION OF EVENT. THE TART WAS NOT READING. PART WAS WORKING. ON 2026-04-03 THE SSU HAS BEEN PROVIDED NEW INFORMATION AS FOLLOWS: ACCORDING TO THE CUSTOMER IT IS UNKNOWN WERE THE PRESSURES ZEROED WHILE THE SET WAS FREE OF LIQUIDS/PRIMING SOLUTION. AS ANOTHER TEAM PRIMES AND ZEROS THE EQUIPMENT PRIOR TO IT ARRIVING IN THE UNIT. BUT THE SYSTEM WAS ZEROED WITH DRY OXY AFTER INITIAL ERRORS ARRIVED. PATIENT WAS SUPPORTED VIA HAND CRANK DURING THIS RESET. NO VISIBLE DEFECT ON THE SENSOR HOUSING OR GREEN FLEXLINE WERE NOTICED BY THE STAFF DURING INVESTIGATION. WHEN WAS THE SET WAS PRIMED (DATE) IS UNKNOWN AT THIS TIME. THE SET WAS CONNECTED TO THE PATIENT AND THE FAILURE WAS NOTICED ON 2026-03-16. THE HLS SET WAS NOT E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843486 ↗
• MalfunctionApr 2, 2026Connection Problem

  THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT WHILE PRIMING THE HLS SET, A "PUMP DISPOSABLE ERROR" OCCURRED. THE HLS SET WAS MOVED TO 3 CARDIOHELP UNITS AND DISPLAYED THE SAME ERROR. SSU CONFIRMED ON 2026-04-01 THAT THERE WAS NO ISSUE WITH THE CARDIOHELP DEVICES, AND NO VISIBLE DAMAGE WAS NOTICED ON THE HLS SET. THE SET WAS NOT USED FOR TREATMENT. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE ¿PUMP DISPOSABLE ERROR" COULD LEAD TO A PUMP STOP DURING TREATMENT THEREFORE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764147 ↗
• MalfunctionMar 18, 2026Noise, Audible

  COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626024 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT A PATIENT WAS PICKED UP A PATIENT AT (B)(6). THE PATIENT WAS SWITCHED ONTO THEIR CARDIO HELP AND HLS SET. THE HLS SET LASTED FOR 48 HOURS WITH NO PROBLEMS ¿ THAN THE CUSTOMER NOTICED A CRACK IN THE DISPOSABLE WHERE BLOOD WAS COMING OUT. NO HARM TO ANY PERSON HAS BEEN REPORTED. ON 2025-03-05 NEW INFORMATION HAS BEEN PROVIDED BY THE SSU (SALES AND SERVICE UNIT) AS FOLLOWS: APPROXIMATELY 10 ML BLOOD WAS LOSS FROM CIRCUIT AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO LEAKAGE. THE HLS SET WAS CONNECTED TO THE PATIENT ON 2026-02-28 AND THE LEAK WAS NOTICED ON 2026-03-02 ON THE PUMP HOUSING. THE HLS SET WAS REPLACED WITH A NEW ONE ON 2026-03-02. DUE TO THE REPORTED BLOOD LEAKAGE AND THE EXCHANGE OF THE HLS SET A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557349 ↗
• InjuryMar 5, 2026Fluid/Blood Leak; Leak/Splash

  THE EVENT OCCURRED IN THE USA DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE PATIENT WAS PLACED ON THE HLS SET ON (B)(6) 2026. ON THE SAME DAY THE PATIENT WAS TRANSPORTED TO (B)(6). ON (B)(6) 2026 A LEAKAGE ON THE HLS SET WAS NOTICED. THE LEAKAGE WAS LOCATED AT THE LUER LOCK SITE ON THE PRE-MEMBRANE SIDE OF THE HLS MODULE. THE CUSTOMER STATED THAT THERE WAS A PIGTAIL CONNECTED TO THE LUER LOCK, WHICH WAS THERE WHEN THE PATIENT HAD BEEN TRANSFERRED IN. FURTHER, A CRACK WAS NOTICED ON THE HLS MODULE AT THE CONNECTION SITE. THUS, THE AFFECTED HLS SET WAS REPLACED. IN ADDITION, THE PATIENT RECEIVED A BLOOD TRANSFUSION. THE AMOUNT OF BLOOD LOSS IS UNKNOWN. THE CUSTOMER CONFIRMED THAT THERE WAS NO COMPLICATION FOR THE PATIENT. COMPLAINT ID# (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 24519469 ↗
• InjuryMar 5, 2026Fluid/Blood Leak; Leak/Splash

  THE EVENT OCCURRED IN THE USA DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE PATIENT WAS PLACED ON THE HLS SET ON (B)(6) 2026. ON THE SAME DAY THE PATIENT WAS TRANSPORTED TO THE (B)(6) HOSPITAL FROM THE (B)(6). ON (B)(6) 2026 A LEAKAGE ON THE HLS SET WAS NOTICED. THE LEAKAGE WAS LOCATED AT THE LUER LOCK SITE ON THE PRE-MEMBRANE SIDE OF THE HLS MODULE. THE CUSTOMER STATED THAT THERE WAS A PIGTAIL CONNECTED TO THE LUER LOCK, WHICH WAS THERE WHEN THE PATIENT HAD BEEN TRANSFERRED IN. FURTHER, A CRACK WAS NOTICED ON THE HLS MODULE AT THE CONNECTION SITE. THUS, THE AFFECTED HLS SET WAS REPLACED. IN ADDITION, THE PATIENT RECEIVED A BLOOD TRANSFUSION. THE AMOUNT OF BLOOD LOSS IS UNKNOWN. THE CUSTOMER CONFIRMED THAT THERE WAS NO COMPLICATION FOR THE PATIENT. COMPLAINT ID# (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 24516703 ↗
• MalfunctionFeb 6, 2026Pressure Problem

  THE EVENT OCCURRED IN THE USA DURING PATIENT TREATMENT. THE PATIENT¿S TREATMENT STARTED AT 11:30 AM WITHOUT ANY ISSUES REGARDING THE INVOLVED HLS-SET AND CARDIOHELP DEVICE. FOUR HOURS LATER AT 03:30 PM ALL READINGS FROM THE INTEGRATED PRESSURE SENSOR CABLE (ARTERIAL PRESSURE, VENOUS PRESSURE, INTERNAL PRESSURE, DELTA P, AND ARTERIAL TEMPERATURE) STOPPED READING ON THE SCREEN AND WERE DISPLAYED AS DASHES. THE GETINGE SALES AND SERVICE UNIT (SSU) ADVISED THE CUSTOMER TO INSPECT THE INTEGRATED PRESSURE SENSOR CABLE INSERTION POINTS FOR CORROSION AND THE HLS SET INTEGRATED PRESSURE SENSOR PORT FOR BENT PINS AND FLUID DAMAGE. NO ABNORMALITIES WERE NOTICED. THE SSU ADVISED THE CUSTOMER TO REPLACE THE INTEGRATED PRESSURE SENSOR CABLE WITH ANOTHER ONE FROM A DIFFERENT CARDIOHELP, HOWEVER THE ISSUE COULD NOT BE RESOLVED. THUS, THE CUSTOMER DECIDED TO SWITCH THE HLS SET FROM THE CURRENT CARDIOHELP (SERIAL #(B)(6)) DEVICE TO A NEW CARDIOHELP DEVICE (SERIAL #90415165). HOWEVER, THE ISSUES COULD NOT BE RESOLVED. THE READINGS FROM THE INTEGRATED PRESSURE SENSOR CABLE WERE STILL DISPLAYED AS DASHES. THE CUSTOMER CONFIRMED THAT THE PATIENT IS STABLE AND DECIDED TO CONTINUE THE PATIENT¿S TREATMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275588 ↗
• MalfunctionFeb 5, 2026Air/Gas in Device

  THE EVENT OCCURRED IN USA. IT WAS REPORTED, THAT DURING PRIMING THE DE-AIRING OF THE HLS SET WAS NOT FUNCTIONING. NO VISIBLE DAMAGE WAS NOTICED DURING PRIMING PROCEDURE. THE AFFECTED HLS SET HAS BEEN USED FOR PATIENT TREATMENT LATER AND ISSUES OCCURRED AGAIN WITH AIR IN THE SYSTEM, AFTER THE INITIAL SUPPORT WAS INITIATED. THEREFORE, ANOTHER HLS SET WAS PRIMED AND WAS CONNECTED TO THE PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE HLS SET WAS REPLACED DURING PATIENT TREATMENT A REPORT IS REQUIRED IN THE USA. COMPLAINT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266250 ↗
• InjuryFeb 4, 2026Fluid/Blood Leak

  THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT A PATIENT WAS PLACED ON AN HLS SET ON (B)(6) 2026. A SMALL AMOUNT OF BLOOD WAS LEAKING ON THE CONNECTION WHERE THE 3/8 TUBE WAS CONNECTED TO THE INLET CONNECTOR OF THE HLS MODULE. DUE TO THE SMALL AMOUNT OF BLOOD LOSS DUE TO THE CRACK THAT WAS NOTICED, THE HLS SET WAS EXCHANGED WITH A NEW ONE. DURING SUPPORT, NO EXCESSIVE PRESSURES WERE DOCUMENTED, OR ADVERSE CONDITIONS WITH THE PUMP WERE DOCUMENTED. THE HLS SET WAS PRIMED AND SET UP ON 2026-01-21 AND AT THAT TIME NO LEAKING OR DAMAGE TO THE SET WAS NOTICED. THE AFFECTED HLS SET IS SCRAPPED BY THE CUSTOMER AND IS NO LONGER AVAILABLE FOR INVESTIGATION. ON 2026-02-03 NEW INFORMATION HAS BEEN PROVIDED BY THE SSU (SALES AND SERVICE UNIT) AS FOLLOWS: ESTIMATED 1000+ ML BLOOD WAS LOST AND THE PATIENT REQUIRED A BLOOD TRANSFUSION. THE SET WAS PRIMED ON (B)(6) 2026 ACCORDING TO THE PRIMING PROCEDURE AND THE HLS SET WAS CONNECTED TO THE PATIENT ON (B)(6) 2026. DURING THE PRIMING NO LEAKAGE WAS NOTICED. DUE TO THE INFORMATION THAT THE PATIENT REQUIRED A BLOOD TRANSFUSION DUE TO THE AMOUNT OF BLOOD LOSS A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258388 ↗
• InjuryFeb 4, 2026Fluid/Blood Leak

  THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT A PATIENT WAS PLACED ON AN HLS SET ON (B)(6) 2026. A SMALL AMOUNT OF BLOOD WAS LEAKING ON THE CONNECTION WHERE THE 3/8 TUBE WAS CONNECTED TO THE INLET CONNECTOR OF THE HLS MODULE. DUE TO THE SMALL AMOUNT OF BLOOD LOSS DUE TO THE CRACK THAT WAS NOTICED, THE HLS SET WAS EXCHANGED WITH A NEW ONE. DURING SUPPORT, NO EXCESSIVE PRESSURES WERE DOCUMENTED, OR ADVERSE CONDITIONS WITH THE PUMP WERE DOCUMENTED. THE HLS SET WAS PRIMED AND SET UP ON (B)(6) 2026 AND AT THAT TIME NO LEAKING OR DAMAGE TO THE SET WAS NOTICED. THE AFFECTED HLS SET IS SCRAPPED BY THE CUSTOMER AND IS NO LONGER AVAILABLE FOR INVESTIGATION. ON 2026-02-03 NEW INFORMATION HAS BEEN PROVIDED BY THE SSU (SALES AND SERVICE UNIT) AS FOLLOWS: ESTIMATED 1000+ ML BLOOD WAS LOST AND THE PATIENT REQUIRED A BLOOD TRANSFUSION. THE SET WAS PRIMED ON (B)(6) 2026 ACCORDING TO THE PRIMING PROCEDURE AND THE HLS SET WAS CONNECTED TO THE PATIENT ON (B)(6) 2026. DURING THE PRIMING, NO LEAKAGE WAS NOTICED. DUE TO THE INFORMATION THAT THE PATIENT REQUIRED A BLOOD TRANSFUSION DUE TO THE AMOUNT OF BLOOD LOSS A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257103 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT A PATIENT WAS PLACED ON SUPPORT (HLS SET) ON (B)(6) 2025. THE PATIENT WAS PLACED ON SUPPORT AT ANOTHER FACILITY AND THEN TRANSFERRED TO THE HARBORVIEW FOR ON-GOING SUPPORT. DURING THE PRIMING PROCESS, NO LEAKS WERE DETECTED ON THE HLS SET. ON (B)(6) 2025 A SMALL LEAK WAS OBSERVED ON THE DIALYSIS LOCK AND VALVE CONNECTOR. DROPS OF BLOOD WERE NOTICED COMING FROM THAT AREA. NO ADVERSE CHANGES TO THE PATIENT WERE NOTICED, NO PRESSURE CHANGES. AFTER NOTICING THE LEAK IN THE HLS SET CUSTOMER DECIDED TO CHANGE OUT THE CIRCUIT. AFTER THE PATIENT WAS PLACED ON A NEW CIRCUIT, NO ADVERSE EFFECTS WERE DOCUMENTED OR REPORTED. ON (B)(6) 2026 NEW INFORMATION HAS BEEN PROVIDED BY THE SSU (SALES AND SERVICE UNIT) AS FOLLOWS: APPROXIMATELY 600+ ML BLOOD WAS LOST, HOWEVER NO BLOOD TRANSFUSION WAS REQUIRED. THE HLS SET WAS CONNECTED TO THE PATIENT ON (B)(6) 2025. THE HLS SET WAS PRIMED ACCORDING TO THE PROCEDURE AND NO LEAKAGE WAS NOTICED DURING PRIMING. DUE TO THE EXCHANGE OF THE HLS SET DURING PATIENT TREATMENT A REPORT IS REQUIRED. (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257100 ↗

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-1076-2024 · Jan 16, 2024 · Open, Classified
  Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. 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-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-1766-2022 · Jul 22, 2022 · Open, Classified
  BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP Sy
• 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-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-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