[pending] Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/
Pending LLM rewrite. Source: FDA_DEVICE Z-1655-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
The recalled product
- 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
- Manufacturer
- ReCor Medical Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: Model No PRDS-068-02
- UDI-DI 00810008950043
- Lot Number: M4862
Distribution
Distributed nationwide across the United States.
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