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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 1
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
Part of a larger recall action
This product is one of 2 recalled by ReCor Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · ReCor Medical Inc.
See all →- HighParadise renal denervation catheter distributed despite being marked for scrapping
FDA (Devices) · 2026-04-08
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