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Cue Ambulatory Volumetric Infusion Pump

by Becton Dickinson Curlin, LLC

510(k) K981816

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

56 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981816 Date4 Dec 1998ClearedStatusActive

Recalls

56 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2054-2019 FDA Class II initiated 27 Feb 2019
    • Terminated Z-2053-2019 FDA Class II initiated 27 Feb 2019

    Administration sets leaked at the filter.

  • 6 recalls, same reason

    • Terminated Z-0698-2018 FDA Class II initiated 10 Nov 2017 on shared 510(k) K981816
    • Terminated Z-0699-2018 FDA Class II initiated 10 Nov 2017 on shared 510(k) K981816
    • Terminated Z-0697-2018 FDA Class II initiated 10 Nov 2017 on shared 510(k) K981816
    • Terminated Z-0700-2018 FDA Class II initiated 10 Nov 2017 on shared 510(k) K981816
    • Terminated Z-0702-2018 FDA Class II initiated 10 Nov 2017 on shared 510(k) K981816
    • Terminated Z-0701-2018 FDA Class II initiated 10 Nov 2017 on shared 510(k) K981816

    Particulate found on the Curlin spike.

    • Terminated Z-0688-2016 FDA Class II initiated 23 Dec 2015

    Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed.

    • Terminated Z-0072-2013 FDA Class II initiated 26 Sep 2012

    This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by

  • 13 recalls, same reason

    • Terminated Z-1668-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1669-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1666-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1667-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1662-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1664-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1659-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1670-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1671-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1665-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1661-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1663-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816
    • Terminated Z-1660-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816

    Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.

    • Terminated Z-1672-2012 FDA Not yet classified initiated 18 May 2012 on shared 510(k) K981816

    Moog Medical Device Group became aware on March 23, 2011 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.

    • Terminated Z-1401-2012 FDA Not yet classified initiated 20 Mar 2012

    Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.

  • 4 recalls, same reason

    • Terminated Z-1869-2011 FDA Unclassified (pre-2012) initiated 28 Feb 2011
    • Terminated Z-1867-2011 FDA Unclassified (pre-2012) initiated 28 Feb 2011
    • Terminated Z-1870-2011 FDA Unclassified (pre-2012) initiated 28 Feb 2011
    • Terminated Z-1868-2011 FDA Unclassified (pre-2012) initiated 28 Feb 2011

    Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.

  • 21 recalls, same reason

    • Terminated Z-2809-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1453-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1444-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1450-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1448-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1454-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1440-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-2807-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1445-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1449-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1455-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1447-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1451-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1442-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1441-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1443-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-2808-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1446-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1452-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1456-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011
    • Terminated Z-1439-2011 FDA Unclassified (pre-2012) initiated 24 Jan 2011

    Defect in tubing may trigger false Air-In-Line warning.

    • Terminated Z-1899-2008 FDA Unclassified (pre-2012) initiated 30 May 2008

    Curlin Medical has investigated five cases of over-delivery/free-flow in the past eight months involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow. The firm's investigations have identified the cause of this deformity to have been a result of the pump being dropped with the door (p

  • 3 recalls, same reason

    • Terminated Z-1896-2008 FDA Unclassified (pre-2012) initiated 30 May 2008
    • Terminated Z-1898-2008 FDA Unclassified (pre-2012) initiated 30 May 2008
    • Terminated Z-1900-2008 FDA Unclassified (pre-2012) initiated 30 May 2008

    Over-delivery/free-flow involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow.

    • Terminated Z-1897-2008 FDA Unclassified (pre-2012) initiated 30 May 2008

    Over-delivery/free-flow in the past eight months involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow.

    • Terminated Z-1129-2007 FDA Unclassified (pre-2012) initiated 9 Feb 2007 on shared 510(k) K981816

    The Administration Sets may leak at the reservior bag.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent