ReCor Medical recalls Paradise Ultrasound Renal Denervation Catheter (PRDS-068-02) due to being nonconforming and not for human use. Affected units were distributed by firm that should have scrapped them.
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
ReCor Medical is recalling Paradise Ultrasound Ren:al Denervation Catheters (PRDS-068-02) because they were distributed as nonconforming products that should have been scrapped and not used on humans. This poses a risk of improper use in medical procedures.
The catheter was distributed as a nonconforming product that was supposed to be scrapped and not for human use. This means it could be unsafe for medical procedures, potentially causing harm if used improperly.
Medical professionals using the Paradise catheter for renal denervation procedures are affected. Patients who received this device during treatment may be at risk if the device was not properly discarded.
Check for the model number PRDS-068-02 on the catheter. The product was distributed by ReCor Medical and may have been sold with lot number M4907.
Look for the model number PRDS-068-02 on the catheter or its packaging.
The catheter was distributed as a nonconforming product that was supposed to be scrapped and not for human use.
The recall record does not specify a remedy, so check with ReCor Medical for guidance.
No, the catheter was supposed to be scrapped and not for human use, so it is not safe for medical procedures.
We’ve drafted a message you can send Paradise to request your refund or repair — edit it as you like.
Subject: Recall Z-1654-2026 — Paradise Paradise Hello, I own a Paradise that is covered by recall Z-1654-2026 from Paradise. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
