Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.

Recall Insight

This FDA Devices action (record #Z-0576-2020) was formally reported on December 4, 2019, with the manufacturer initiating the action on December 7, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Spectranetics Corporation is listed as the recalling firm, operating out of Fremont, CA. Federal records indicate 3 catheters units are affected.

The documented reason for this recall is: The incorrect outer carton box was used for the product. Distribution data in the federal record shows the product reached: Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.. 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 7 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.