ReCor Medical Paradise renal denervation catheter recalled for nonconforming device
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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
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 90 years)
This recall covers 2 products — see all of them.
Details
- Units affected
- 24
- Illnesses reported
- None reported
- Manufactured in
- 1049 Elwell Ct, Palo Alto, CA, United States
- Classification
- Class II
- Recall number
- Z-1655-2026
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: M4862 Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA. Affected quantity: 24
- 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…Z-1654-2026 · 1
- Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common… (this page)Z-1655-2026 · 24