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Paradise Ultrasound Renal Denervation Catheter
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MEDICAL DEVICE RECALLMODERATE

Paradise Ultrasound Renal Denervation Catheter

ReCor Medical is recalling the Paradise Ultrasound Renal Denervation Catheter (Model PRDS-068-02) as these units were intended to be scrapped.

What to do

Stop using the affected catheter immediately and contact ReCor Medical for instructions on returning the product.

Recalled
Listed
Updated
Recall No.
Z-1654-2026
Agency
FDA
Firm
ReCor Medical Inc.
Recall ID
98365
Status
ONGOING

Why it was recalled

ReCor Medical is recalling the Paradise Ultrasound Renal Denervation Catheter because the firm distributed units that were intended to be scrapped and are not for human use. The affected model is PRDS-068-02.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Paradise¿ Ultrasound Renal Denervation System Paradise ¿ CatheterUDI-DI: 00810008950043Model/Catalog number: PRDS-068-02

Recall #
Z-1654-2026
Z-1655-2026

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification