Paradise renal denervation catheter unit distributed despite scrapping designation
One Paradise Ultrasound Renal Denervation catheter was distributed although it was a nonconforming product that should have been scrapped and not used in humans.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall in which a product not fit for human use reached the field, a risk of harm with no injuries reported in the source.
Plain-English summary
The Paradise Ultrasound Renal Denervation System catheter, model/catalog number PRDS-068-02, is subject to recall. The action covers a single unit.
The firm distributed a nonconforming product that was supposed to be scrapped and not intended for human use. The device is an ablation catheter used in renal denervation procedures. The FDA classified the action as Class II.
Distribution was in the United States, across the states of California, Colorado, Florida, Kansas, Missouri, North Carolina, Ohio, Texas and Virginia. The catheter is supplied to healthcare facilities rather than sold to consumers.
Facilities should follow the manufacturer's instructions for identifying and quarantining the affected unit and contact the firm with any questions.
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
- Manufacturer
- ReCor Medical Inc.
- Hazard
- nonconforming-product
- ablation-catheter
- class-ii
- quality-escape
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: Model No PRDS-068-02
- UDI-DI 00810008950043
- Lot Number: M4907
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22