InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.

Recall Insight

This FDA Devices action (record #Z-1621-2014) was formally reported on May 21, 2014, with the manufacturer initiating the action on March 14, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. InterValve Inc is listed as the recalling firm, operating out of Minnetonka, MN. Federal records indicate 2 units are affected.

The documented reason for this recall is: Leak issues were discovered through accelerated age testing. Distribution data in the federal record shows the product reached: Distribution to TN only. 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 and NHTSA 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 12 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.