Cordis EMPIRA NC RX PTCA Dilatation Catheter

Recall Insight

This FDA Devices action (record #Z-2556-2014) was formally reported on September 3, 2014, with the manufacturer initiating the action on June 23, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Cordis Corporation is listed as the recalling firm, operating out of Miami Lakes, FL. Federal records indicate 250,000 units units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover.… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, …. 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 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.