MAQUET CARDIOHELP CARDIOHELP Base UnitRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04037691658247), received between Jan 23, 2026 and Jan 23, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K133598); 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  COMPLAINT ID (B)(4).

  Patient problems: Ischemia Stroke

  MAUDE report 24161506 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MAQUET CARDIOPULMONARY GMBH HAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES ON 2026-01-19: THE VIGILANCE AREA OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES HAS BEEN INFORMED THROUGH RENACER REGISTRY ABOUT AN INCIDENT INVOLVING THE PRODUCT ¿CARDIOHELP¿, MANUFACTURED BY GETINGE AND DISTRIBUTED BY, OCCURRED ON (B)(6) 2025 WITH REPORT NUMBER (B)(4). THE INFORMATION WAS PROVIDED THAT THE PATIENT HAD THE INCIDENT "NEUROLOGICAL EVENT. LEFT ANTERIOR CIRCUMFLEX ARTERY ISCHAEMIC STROKE". AS THE PATIENT SUFFERED A SERIOUS INJURY, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

  Patient problems: Ischemia Stroke

  MAUDE report 24158722 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133598. One submission often covers many models, so check the product and lot details in each record.

• Z-1300-2026 · Jan 9, 2026 · Open, Classified
  Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
• Z-1831-2024 · Apr 15, 2024 · Open, Classified
  CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
• Z-1053-2024 · Dec 28, 2023 · Open, Classified
  Bubble Sensor (REF: 70105.5720)
• Z-0595-2024 · Nov 14, 2023 · Open, Classified
  CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulm
• Z-0605-2024 · Nov 13, 2023 · Open, Classified
  Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
• Z-0555-2024 · Nov 6, 2023 · Open, Classified
  CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pu
• Z-0290-2024 · Oct 12, 2023 · Open, Classified
  Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
• Z-0420-2024 · Oct 10, 2023 · Open, Classified
  CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
• Z-0897-2022 · Feb 18, 2022 · Open, Classified
  Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circ