FDA Medical Device Recalls (openFDA)
ReCor Medical Inc.: 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
- Recall number
- Z-1654-2026
- Recalling firm
- ReCor Medical Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2026-01-29
- Posted
- 2026-03-27
- Terminated
- not on file
- Reason
- Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
- Root cause
- Under Investigation by firm
- Action
- On 01/28/2026, the firm informed customers verbally and sent via mail an "MEDICAL DEVICE RECALL" Letter that nonconforming products (cracking in the hub adjacent to the guidewire port) that may lead to fluid leaks and could trigger a pressure error. Customers are instructed to: 1. Do not use the affected catheters for any patient procedures. 2. Identify the catheters from the affected lot and return to Recor Clinical Specialist through RMA process. 3. Review and complete the Acknowledgement and Receipt Form and provide to the Recor Clinical Specialist. For questions or further assistance - contact Director of Regulatory & Quality Compliance at Lisa.luu@recormedical.com or telephone at 650-542-7700
- Quantity
- 1
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
- Lot, serial or model codes
- Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907
- 510(k) numbers
- not on file
- PMA numbers
- ["P220023"]
- Product code
- QYI
- Firm FEI
- 3010024164
- Firm city
- Palo Alto
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28