Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported December 13, 2023
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
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. Potenti…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Maquet Medical Systems USA recalled CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System i… - a critical-severity action.
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System i… was recalled by Maquet Medical Systems USA in December 13, 2023. Reason: Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead…. Check the official notice for the remedy. Verify recall #Z-0420-2024 with the FDA Devices before acting.
The recall
Maquet Medical Systems USA issued this critical-severity FDA Devices recall-Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead….
- Critical
- severity level
- Class I
- classification
- December 13, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0420-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0420-2024) was formally reported on December 13, 2023, with the manufacturer initiating the action on October 10, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Maquet Medical Systems USA is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S..
The documented reason for this recall is: 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 hyp… Distribution data in the federal record shows the product reached: US Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC, FL, HI, IA, IL, IN, KY, MD, MI, MN, MO, NE, OH, SC, VA Foreign distribution to: Austria, Australia, Brazil, Canada, Chile, China, Czech Re…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S.
Related Recalls
6
3 from same agency
Product description
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0420-2024 |
| Date reported | December 13, 2023 |
| Date initiated | October 10, 2023 |
| Recalling firm | Maquet Medical Systems USA |
| Firm location | Wayne, NJ |
| Affected scope | Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S. |
| Distribution | US Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC, FL, HI, IA, IL, IN, KY, MD, MI, MN, MO, NE, OH, SC, VA Foreign distribution to: Austria, Australia, Brazil, Canada, Chile, China, Czech Republic, Finland, Fra… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0420-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.. Recalled by Maquet Medical Systems USA. Units affected: Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2023. Severity: Critical. Recall number: Z-0420-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC, FL, HI, IA, IL, IN, KY, MD, MI, MN, MO, NE, OH, SC, VA Foreign distribution to: Austria, Australia, Brazil, Canada, Chile, China, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Jordan, Mexico, New Zealand, Pakistan, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0420-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 13, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.