ReCor Medical Inc. has issued an active recall for 24 Paradise ultrasound renal denervation catheters distributed nationwide in nine states. The devices were nonconforming and were supposed to be scrapped and not for human use. Healthcare providers and patients should stop using the devices immediately and await manufacturer recall instructions.
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ReCor Medical Inc. or your healthcare provider for instructions. Notification method: Letter
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The Paradise Ultrasound Renal Denervation System includes a catheter used in renal denervation procedures. It is distributed in healthcare settings within the United States.
The recall addresses a nonconforming product that should have been scrapped, posing potential safety concerns if used in patients.
This recall is not described as part of a broader industry pattern.
Healthcare providers may need to identify and segregate affected catheters, adjust procedures, and contact patients if exposure occurred.
Device labeling and FDA recall page summarize identifiers.
Not specified in recall notice.
Retain recall notice, packaging, labeling, correspondence with manufacturer, and any patient exposure records.
Model/Catalog Number PRDS-068-02. UDI-DI 00810008950043. Lot Number M4862. Quantity 24. Sold nationwide in CA, CO, FL, KS, MO, NC, OH, TX, and VA.
No injuries or incidents have been reported.
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