MAQUET CARDIOHELP BS 3/8x3/32 L1.7Recalls & reported problems

Summary

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

2 FDA recall records name this device's identifier, 2 still open.

7 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. Jan 9, 2026Class IIOpen, Classified

   Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.

   Z-1300-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 28, 2023Class IIOpen, Classified

   The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

   Z-1053-2024 · Root cause: Labeling mix-ups · 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-1831-2024 · Apr 15, 2024 · Open, Classified
  CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
• 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 circu