The Recall Desk
HighFDA (Devices)·Z-1188-2023·Announced 2023-03-08

Maquet CARDIOHELP System extracorporeal support device components recalled for sterility

Maquet is recalling CARDIOHELP System components due to insufficient evidence of packaging sterility. Non-sterile medical devices could expose patients to infection, sepsis, or ischemia.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a critical care medical device. The source text does not report any hospitalizations, illnesses, or injuries. The potential hazards—infection, sepsis, ischemia—are serious but theoretical. Per the severity rubric, risk-of-harm medical devices without reported harm are classified as High (3).

Plain-English summary

Maquet Medical Systems USA has initiated a recall of the BEQ-HLS 5050 USA (HLS Set Advanced 5.0, Product Code 70106.9077) and BEQ-HLS 7050 USA (HLS Set Advanced 7.0, Product Code 70106.9078), components of the CARDIOHELP System used for extracorporeal respiratory and cardiovascular support. The recall was issued due to insufficient evidence of packaging sterility.

Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia. The recall affects 10,587 units distributed in the United States and approximately 94,987 units distributed worldwide across multiple countries.

Healthcare providers using these components should contact Maquet Medical Systems USA for recall instructions and guidance.

The recalled product

Product
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
Manufacturer
Maquet Medical Systems USA
Category
Medical Device — Extracorporeal Support System
Hazard
  • non-sterile-device
  • infection
  • sepsis
  • ischemia

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • HLS Set Advanced 5.0
  • Product Code 70106.9077 UDI-DI 04058863076355 HLS Set Advanced 7.0
  • Product Code 70106.9078 UDI-DI 04058863080383 All lots/batches affected

Distribution

Distributed nationwide across the United States.

Related recalls

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