MAQUET CARDIOHELP CARDIOHELP Emergency Drive (w/o holder)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 10, 2023Class IOpen, Classified

   Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.

   Z-0420-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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-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 circu