Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.

Recall Insight

This FDA Devices action (record #Z-1828-2015) was formally reported on July 1, 2015, with the manufacturer initiating the action on May 6, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Terumo Cardiovascular Systems Corp is listed as the recalling firm, operating out of Ashland, MA. Federal records indicate 163 devices units are affected.

The documented reason for this recall is: The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal … Distribution data in the federal record shows the product reached: Distributed to the states of MO and FL.. 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 11 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.