FDA-Device2026-04-08Class IIPROCESSING DEFECT
ReCor Medical Paradise renal denervation catheter recalled for nonconforming device
What this means
ReCor Medical distributed 24 units of Paradise ultrasound renal denervation catheters (Model PRDS-068-02) that did not meet quality standards and were supposed to be destroyed, not sold. The devices were distributed in nine states: California, Colorado, Florida, Kansas, Missouri, North Carolina, Ohio, Texas, and Virginia. No injuries have been reported.
- If you have a Paradise catheter (Model PRDS-068-02, Lot M4862), do not use it.
- Contact your healthcare provider or hospital immediately to report that you may have received a recalled device.
- Return the device to ReCor Medical or the facility where it was used.
The agency's original wording
Hazard
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
Affected count
24
Manufactured in
1049 Elwell Ct, Palo Alto, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1655-2026Want us to check the next one for you?
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