CS 100i Intra-Aortic Balloon Pump

Recall Insight

This FDA Devices action (record #Z-2736-2017) was formally reported on August 2, 2017, with the manufacturer initiating the action on June 16, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Maquet Datascope Corp - Cardiac Assist Division is listed as the recalling firm, operating out of Mahwah, NJ. Federal records indicate 12,319 units total units are affected.

The documented reason for this recall is: The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device … Distribution data in the federal record shows the product reached: Worldwide Distribution - (in over 100 countries) US (Nationwide). 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 9 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.