ReCor Medical Paradise renal denervation catheter recalled for nonconforming manufacturing
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.
From the FDA notice · Read the official notice ↗
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- 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
- Sold in
- Nationwide
- Made for
- Adults (18 years to 100 years)
This recall covers 2 products — see all of them.
Details
- Units affected
- 1
- Illnesses reported
- None reported
- Manufactured in
- 1049 Elwell Ct, Palo Alto, CA, United States
- Classification
- Class II
- Recall number
- Z-1654-2026
In the FDA's words
- Description
- 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 Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907 Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA. Affected quantity: 1
- Hazard
- Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
2 products in this recall
The agency lists each product separately. Check every one you might have.
- Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common… (this page)Z-1654-2026 · 1
- Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common…Z-1655-2026 · 24