CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

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 indicate Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S. units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.