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Paradise™

by ReCor Medical, Inc.

Ref PRDS-USG-2X, PRDS-068-02, PRDS-067-02, PRDS-066-02, PRDS-064-02, PRDS-063-02

Paradise (PRDS-USG-2X) is a medical device (EU MDD Class IIb; FDA Class III; FDA product code QYI, Ablation Catheter, Renal Denervation) made by Recor Medical, Inc., registered in EUDAMED on 8 Apr 2024 (Basic UDI-DI B-00810008950128), approved under FDA PMA P220023 on 7 Nov 2023 and listed in FDA GUDID since 11 Dec 2023 (UDI-DI 00810008950128), active as of 24 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

PMA P220023

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00810008950128 Basic UDI-DI Date8 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00810008950128 UDI-DI Date11 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP220023 Date7 Nov 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00810008950128 registered 8 Apr 2024 Active
  • FDA PMA P220023 decided 7 Nov 2023 Active
  • FDA GUDID UDI-DI 00810008950128 listed 11 Dec 2023 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1655-2026 FDA Class II initiated 29 Jan 2026
    • Ongoing Z-1654-2026 FDA Class II initiated 29 Jan 2026

    Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

Timeline

5 dated events

  1. Approved FDA PMA P220023
  2. Listed FDA GUDID 00810008950128
  3. Registered EUDAMED B-00810008950128
  4. Recall initiated FDA recalls Z-1655-2026
  5. Recall initiated FDA recalls Z-1654-2026

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
Paradise™ EUDAMED
Paradise® Catheter GUDID
Paradise® Generator GUDID
Generic name
Renal denervation ultrasound system catheter
Renal denervation ultrasound system generator
Device name
Paradise Catheter 8mm
Paradise Catheter 7mm
Paradise Catheter 6mm
Paradise Catheter 4.2mm
Paradise Catheter 3.5mm
Model / Ref / Catalog
PRDS-USG-2X, PRDS-067-02, PRDS-064-02, PRDS-063-02, PRDS-066-02, PRDS-068-02
Primary DI / UDI-DI
00810008950128, 00810008950036, 00810008950005, 00810008950111, 00810008950067, 00810008950029, 00810008950043
Basic UDI-DI
B-00810008950128, B-00810008950043, B-00810008950111, B-00810008950036, B-00810008950029, B-00810008950005, B-00810008950067
PMA number
FDA product code
QYI
EMDN code
Z129099, K02050109
GMDN term
Renal denervation ultrasound system catheter
Renal denervation ultrasound system generator
Device class
Class IIb EUDAMED
Class III GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Balloon Diameter — 7 Millimeter
Balloon Diameter — 4.2 Millimeter
Balloon Diameter — 3.5 Millimeter
Balloon Diameter — 6 Millimeter
Balloon Diameter — 8 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class III

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000027816
Authorised representative
ICON (LR) Limited IE-AR-000006507

Related devices

Category: Fixture/appliance dental drill bit, reusable

Similar devices in this category

Other devices filed under ELECTROSURGERY DEVICES, SINGLE-USE.

Other devices from Recor Medical, Inc.

See all devices from Recor Medical, Inc. →

Properties

  • Supplied sterile NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Single use YesGUDIDNoGUDID
  • Prescription use
  • Lot / batch number YesGUDIDNoGUDID
  • Serial number NoGUDIDYesGUDID
  • Expiration date YesGUDIDNoGUDID
  • Manufacturing date NoGUDIDYesGUDID
Other properties (16, all answered No)