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DiamondTemp™ Irrigation Pump CEDTP100

by Medtronic, Inc. 4 variants

DiamondTemp Irrigation Pump CEDTP100 is a basic roller pump (FDA Class III; FDA product code OAE, Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation) made by Medtronic, Inc., approved under FDA PMA P200028 on 28 Jan 2021 and listed in FDA GUDID since 23 Oct 2021 (UDI-DI 00763000482145), active as of 23 Oct 2026. 6 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

PMA P200028

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000482145 UDI-DI Date23 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP200028 Date28 Jan 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P200028 decided 28 Jan 2021 Active
  • FDA GUDID UDI-DI 00763000482145 listed 23 Oct 2021 Listed

Recalls

6 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-1320-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1318-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1317-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1322-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1319-2021 FDA Class II initiated 22 Feb 2021
    • Ongoing Z-1321-2021 FDA Class II initiated 22 Feb 2021

    It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.

Timeline

8 dated events

  1. Approved FDA PMA P200028
  2. Recall initiated FDA recalls Z-1320-2021
  3. Recall initiated FDA recalls Z-1318-2021
  4. Recall initiated FDA recalls Z-1317-2021
  5. Recall initiated FDA recalls Z-1322-2021
  6. Recall initiated FDA recalls Z-1319-2021
  7. Recall initiated FDA recalls Z-1321-2021
  8. Listed FDA GUDID 00763000482145

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
DiamondTemp™ Irrigation Pump
Generic name
Basic roller pump
Model / reference
CEDTP100
Primary DI / UDI-DI
00763000482145
PMA number
FDA product code
OAE
GMDN term
Basic roller pump
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic roller pump

Cleared under the same submission (P200028)

and 8 more cleared under P200028

Similar devices

Other devices filed under FDA product code OAE (Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation).

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)