Paradise renal denervation catheter distributed despite being marked for scrapping
Recor Medical is recalling one lot of the Paradise Ultrasound Renal Denervation System Catheter because a nonconforming product that should have been scrapped was distributed instead.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: product the firm had designated as not for human use reached patients, and no injuries are stated in the source.
Plain-English summary
The Paradise Ultrasound Renal Denervation System Catheter, an ablation catheter for renal denervation, model PRDS-068-02, is being recalled. About 24 units were distributed across nine US states. The FDA has classified this recall as Class II.
The recall was initiated because the firm distributed a nonconforming product that was supposed to be scrapped and not for human use.
Affected product carries UDI-DI 00810008950043 and lot number M4862.
Facilities can identify affected catheters by the model number, UDI and lot above, and may contact the recalling firm for further information.
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
- 24
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: M4862
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 unit distributed despite scrapping designation
FDA (Devices) · 2026-04-08
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