Maquet Bubble Sensor Recall: Incorrect UDI Device Identifier Risk

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Recalling firmMaquet Medical Systems USA45 Barbour Pond Dr · Wayne, NJ 07470-2094

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Maquet is recalling Bubble Sensors for the CARDIOHELP-i extracorporeal life support system due to an incorrect UDI Device Identifier on the labels. This could lead to improper identification of the device, potentially causing safety issues in medical use.

Why it’s dangerous

The Bubble Sensor accessory includes a wrong UDI Device Identifier (DI) on its label. This incorrect code could lead to improper identification of the device during medical use, potentially causing safety issues in critical care situations.

Who’s affected

Healthcare professionals using the CARDIOHELP-i system with the affected Bubble Sensors. Patients receiving extracorporeal life support are at risk if the incorrect identifier causes misidentification.

How to tell if you have this one

Check for the model BS 3/8x3/32 L1.7 with serial numbers listed in the recall (e.g., 90041799, 90041816). The incorrect UDI DI on the label is 04058863025148 instead of the correct 04037691816432.

Brand
Maquet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Label
Look for the UDI Device Identifier on the label; the incorrect code is 04058863025148.
Verify Serial Numbers
Affected units have specific serial numbers listed in the recall notice.

✎ GovInfoNow

Questions people ask

What is the correct UDI Device Identifier for the Bubble Sensor?

The correct UDI Device Identifier is 04037691816432.

Which serial numbers are affected?

Affected serial numbers include 90041799, 90041816, 90041938, and others as listed in the recall.

How can I confirm if my Bubble Sensor is affected?

Check the model number (BS 3/8x3/32 L1.7) and serial number against the list provided in the recall notice.

Take action

Contact Maquet

We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1053-2024 — Maquet Maquet

Hello,

I own a Maquet that is covered by recall Z-1053-2024 from Maquet.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1053-2024 (December 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1053-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Maquet Medical Systems USA recalls Bubble Sensor (REF: 70105.5720)

Lower-risk recall