CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbo
Summary
The FDA issued a Class I for CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP by Maquet Medical Systems USA. Reason: Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inapprop.
Details
Source
Device Recall
External ID
Z-0420-2024
Action Date
2023-12-13
Status
Ongoing
Category
device
Product Description
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Lot/Code Info: Part No. 701048002: UDI - 04037691643526; Serial Numbers 90425259 to 90425748 (Excluding 90425438, 90425443, 90425568, 90425570, 90425588, 90425716) [***Updated 1/8/24 to include Serial numbers 90421507, 90421980, 90424277. Serial numbers 90425366 and 90423121 are additionally included in the scope due to internal complaints, but these units were corrected prior to the field action initiation and therefore are not included in customer notification***] Part No. 701076205: No UDI; Serial Numbers 90425438, 90425443, 90425568, 90425570, 90425588, 90425716, 90425747, 90425748
Quantity Affected: Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S.
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-10
Company
Wayne, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Medical Systems USA has 36 FDA actions in our database, including 36 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Medical Systems USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Medical Systems USA have FDA actions?
Maquet Medical Systems USA has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0420-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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