ReCor Paradise Renal Denervation Catheter Class II Recall
Summary
FDA classified a Class II recall of ReCor Medical Inc.'s Paradise™ Ultrasound Renal Denervation System catheters (Model PRDS-068-02). The firm initiated the recall after distributing a nonconforming product that was supposed to be scrapped and not intended for human use. The device is an ablation catheter used for renal denervation. The recall affects units distributed nationwide in CA, CO, FL, KS, MO, NC, OH, TX, and VA. The recall is ongoing with no specified end date.
What changed
ReCor Medical initiated a Class II recall for Paradise™ Ultrasound Renal Denervation Catheters after discovering that nonconforming products intended for destruction were distributed for human use. The FDA classified this as a Class II recall on April 8, 2026. Healthcare providers who received these catheters in CA, CO, FL, KS, MO, NC, OH, TX, and VA should immediately cease use and return affected units per manufacturer instructions.
Medical device manufacturers should review this recall as an indicator of quality control vulnerabilities. The distribution of products designated for scrapping suggests potential gaps in device segregation, documentation, or disposal protocols. Firms should assess whether similar control failures could occur in their own operations and strengthen device traceability and nonconforming product management procedures.
What to do next
- Cease use and return affected Paradise catheters (Model PRDS-068-02)
- Contact ReCor Medical for recall instructions
- Report any adverse events associated with the device
Archived snapshot
Apr 14, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
ReCor Medical Inc.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1655-2026 · 20260408 · Ongoing
Product
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
Reason for Recall
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Distribution
U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
Source: openFDA Enforcement API
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