CLASS II Device recall · Reported 4 Aug 2021 · FDA Enforcement Report

Heater Cooler Unit (HCU The device supplies recalled

Maquet Medical Systems USA is recalling Heater Cooler Unit (HCU The device supplies temperature-controlled water for cardioplegia, distributed in 10 states. The recall was initiated on 14 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesHCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected.

Quantity recalled33

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2140-2021
FDA event ID: 88285
Recalling firm: Maquet Medical Systems USA, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 14 Jul 2021
FDA classified: 23 Jul 2021
Reported: 4 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

14 Jul 2021	Recall initiated by company
23 Jul 2021	Classified by FDA	+9 days
4 Aug 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.

Where it was distributed

Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.

Alabama California Florida Illinois Kansas Michigan Missouri North Carolina Nebraska Ohio

Questions about this recall

Why was it recalled?

There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.

Which lots are affected?

HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected.

Where was it sold?

Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Maquet Medical Systems USA

All 41

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22 May 2024Device	CLASS II	Cardiohelp-i System recalled by Maquet Medical Systems U	Maquet Medical Systems USA	Packaging Defects	Nationwide
21 Feb 2024Device	CLASS II	Model No. Beq-hls 5050 USA, HLS Set Advanced 5.0, Product Code/Part recalled	Maquet Medical Systems USA	Sterility	Nationwide
21 Feb 2024Device	CLASS II	Beq-hls 7050 USA, HLS Set Advanced 7.0, Product recalled	Maquet Medical Systems USA	Sterility	Nationwide
14 Feb 2024Device	CLASS II	Beq-rf-32-Usa RotaFlow Centrifugal Pump recalled	Maquet Medical Systems USA	Sterility	Nationwide
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