Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

475 results found for infusion pump Page 6 of 19
CareFusion 303, Inc.
Class II Ongoing
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Reason: Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to tra...
Z-1192-2023 March 8, 2023 San Diego, CA
Smiths Medical ASD Inc.
Class II Ongoing
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infu...
Reason: Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
Z-0272-2023 November 30, 2022 Minneapolis, MN
Baxter Healthcare Corporation
Class I Ongoing
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
Reason: Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d...
Z-0142-2023 November 9, 2022 Deerfield, IL
Baxter Healthcare Corporation
Class I Ongoing
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
Reason: Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d...
Z-0144-2023 November 9, 2022 Deerfield, IL
Baxter Healthcare Corporation
Class I Ongoing
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
Reason: Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d...
Z-0145-2023 November 9, 2022 Deerfield, IL
Baxter Healthcare Corporation
Class I Ongoing
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
Reason: Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d...
Z-0143-2023 November 9, 2022 Deerfield, IL
Baxter Healthcare Corporation
Class I Ongoing
Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, P7900B100195, P7900B100230, P7900B100236, P7900B100239, P7900B100244, P7900B1002...
Reason: Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d...
Z-0141-2023 November 9, 2022 Deerfield, IL
Unomedical A/S
Class II Terminated
Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.
Reason: The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
Z-1810-2022 October 5, 2022 LEJRE, N/A
Intera Oncology, Inc.
Class I Terminated
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Reason: Higher than expected flow rate.
Z-1522-2022 August 31, 2022 Wellesley, MA
Medtronic MiniMed
Class II Ongoing
MiniMed 720G Insulin Pump (O.U.S. Version)
Reason: Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of th...
Z-1356-2022 July 20, 2022 Northridge, CA
Medtronic MiniMed
Class II Ongoing
MiniMed 640G Insulin Pump (O.U.S. Version)
Reason: Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of th...
Z-1354-2022 July 20, 2022 Northridge, CA
Medtronic MiniMed
Class II Ongoing
MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
Reason: Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of th...
Z-1358-2022 July 20, 2022 Northridge, CA
Medtronic MiniMed
Class II Ongoing
MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
Reason: Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of th...
Z-1355-2022 July 20, 2022 Northridge, CA
Medtronic MiniMed
Class II Ongoing
MiniMed 630G Insulin Pump (U.S. and Canada Version)
Reason: Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of th...
Z-1353-2022 July 20, 2022 Northridge, CA
Medtronic MiniMed
Class II Ongoing
MiniMed 620G Insulin Pump (O.U.S. version)
Reason: Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of th...
Z-1352-2022 July 20, 2022 Northridge, CA
Medtronic MiniMed
Class II Ongoing
MiniMed 740G Insulin Pump (O.U.S. Version)
Reason: Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of th...
Z-1357-2022 July 20, 2022 Northridge, CA
Medtronic MiniMed
Class II Ongoing
MiniMed 780G Insulin Pump (O.U.S. Version)
Reason: Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of th...
Z-1359-2022 July 20, 2022 Northridge, CA
InfuTronix LLC
Class II Ongoing
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP
Reason: An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.
Z-0832-2022 April 6, 2022 Natick, MA
B Braun Medical Inc
Class II Terminated
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Reason: Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can re...
Z-0819-2022 March 30, 2022 Breinigsville, PA
Smiths Medical ASD Inc.
Class II Ongoing
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main ...
Reason: There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start u...
Z-0653-2022 February 23, 2022 Minneapolis, MN
Baxter Healthcare Corporation
Class I Ongoing
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
Reason: There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set...
Z-0529-2022 February 9, 2022 Deerfield, IL
Baxter Healthcare Corporation
Class I Ongoing
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
Reason: There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set...
Z-0530-2022 February 9, 2022 Deerfield, IL
Smiths Medical ASD Inc.
Class I Terminated
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-1...
Reason: Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line eve...
Z-0107-2022 October 27, 2021 Minneapolis, MN
Baxter Healthcare Corporation
Class I Terminated
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Reason: Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum I...
Z-2165-2021 August 18, 2021 Deerfield, IL
BioMedical Equipment Service Co (BMES)
Class I Terminated
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
Reason: Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel....
Z-2204-2021 August 18, 2021 Louisville, KY