EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358

Recall Insight

This FDA Devices action (record #Z-1319-2021) was formally reported on April 7, 2021, with the manufacturer initiating the action on February 22, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Epix Therapeutics, INC is listed as the recalling firm, operating out of Sunnyvale, CA. Federal records indicate 15 units units are affected.

The documented reason for this recall is: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in … Distribution data in the federal record shows the product reached: Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada. 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 5 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.