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MetriQ™ Pump M0044100D0

by Boston Scientific

MetriQ Pump M0044100D0 is a basic roller pump (FDA Class III; FDA product code OAD, catheter, percutaneous, cardiac ablation, for treatment of atrial flutter) made by Boston Scientific, approved under FDA PMA P150005 on 24 Feb 2016 and listed in FDA GUDID since 17 Jan 2018 (UDI-DI 08714729862109), active as of 23 Oct 2026. One FDA recall is linked to it.

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P150005

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 Number08714729862109 UDI-DI Date17 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP150005 Date24 Feb 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P150005 decided 24 Feb 2016 Active
  • FDA GUDID UDI-DI 08714729862109 listed 17 Jan 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0699-2019 FDA Class III initiated 28 Nov 2018

    Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.

Timeline

3 dated events

  1. Approved FDA PMA P150005
  2. Listed FDA GUDID 08714729862109
  3. Recall initiated FDA recalls Z-0699-2019

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
MetriQ™ Pump
Generic name
Basic roller pump
Model / Ref / Catalog
M0044100D0
Primary DI / UDI-DI
08714729862109
PMA number
FDA product code
OAD
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 (P150005)

and 8 more cleared under P150005

Similar devices

Other devices filed under FDA product code OAD (catheter, percutaneous, cardiac ablation, for treatment of atrial flutter).

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)