ReCor Medical recalls Paradise Ultrasound Renal Denervation System catheters (PRDS-068-02) due to nonconforming product that was supposed to be scrapped and not for human use. Affected units may pose safety risks.
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
ReCor Medical is recalling Paradise Ultrasound Renal: catheters with model PRDS-068-02 because they were distributed as nonconforming products that should have been scrapped and not used on humans. This poses a safety risk as these catheters were not intended for human use.
The product was distributed as nonconforming items that were supposed to be scrapped and not for human use. This means the catheters were not intended for medical procedures and could pose safety risks if used improperly.
Patients who received the Paradise Ultrasound Renal Denervation System catheter (model PRDS-068-02) during procedures are likely affected. Medical professionals using this specific model for renal denervation procedures are at risk.
Check for the model number PRDS-068-02 on the catheter. The product was distributed with a lot code M4862 and UDI-DI 00810008950043. This specific catheter was intended for renal denervation procedures but was incorrectly distributed as nonconforming.
Identify the model number PRDS-068-02 on the catheter to confirm if it is affected.
The product was distributed as nonconforming items that were supposed to be scrapped and not for human use.
The official recall notice does not specify a remedy or action steps for affected products.
No, the product was not intended for human use and was distributed as nonconforming items that should have been scrapped.
We’ve drafted a message you can send ReCor Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1655-2026 — ReCor Medical ReCor Medical Hello, I own a ReCor Medical that is covered by recall Z-1655-2026 from ReCor Medical. 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.
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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.
