FDA-Device2026-04-08Class IIPROCESSING DEFECT
ReCor Medical Paradise renal denervation catheter recalled for nonconforming manufacturing
What this means
ReCor Medical distributed one Paradise ultrasound renal denervation catheter (Model PRDS-068-02, Lot M4907) that did not meet manufacturing standards and was supposed to be destroyed. The device was distributed in nine U.S. states. No injuries have been reported.
- If you received or implanted this device, contact ReCor Medical or your healthcare provider immediately
- Verify the lot number matches M4907 and UDI-DI 00810008950043
- Do not use this catheter
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
1
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-1654-2026Want us to check the next one for you?
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