Device, Cystometric, Hydraulic
Gastroenterology, Urology · 21 CFR 876.1620
Recent MDR events
119 adverse event reports on file
- PUMP ON THE URODYNAMIC STUDY SYSTEM - UDSDec 26, 2024MalfunctionLaborie Medical Technologies Corp.MW5163950
- PORTASCAN TM 3DSep 11, 2024MalfunctionLaborie Medical Technologies Corp.20189965
- LABORIE AIR-CHARGED CATHETERSMay 3, 2024MalfunctionLaborie Medical Technologies Corp.MW5154584
- URODYNAMICS DUET MACHINEAug 12, 2023MalfunctionLaboriesMW5136670
- AIR-CHARGED SINGLE SENSOR CATHETERJun 7, 2023MalfunctionLaborie Medical Technologies Corp17078235
- TDOC-7FS AIR-CHARGED SINGLE SENSOR CATHETERFeb 24, 2023MalfunctionLaborie Medical Technologies Canada Ulc16434945
- FIXED FOCAL LENGTH COUPLER 19MMJul 26, 2022MalfunctionMedos International Sarl1221934-2022-02237
- AIR-CHARGED SINGLE SENSOR COUDÉ CATHETERMay 3, 2022MalfunctionLaborie Medical Technologies14266036
- DEVICE, CYSTOMETRIC, HYDRAULICMar 31, 2022MalfunctionLaborie Medical Technologies3017448360-2022-00010
- URODYNAMIC URINARY CATHETERJan 20, 2021MalfunctionLaborie Medical Technologies, Canada UlcMW5098931
Event type breakdown
Recalls
3 recall events for this product code
- Laborie Medical TechnologiesTerminatedDec 1, 2006
Laborie Transducer Cartridge with Luer Lock
Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041
Z-0229-2007 · View FDA record ↗ - LABORIE MEDICAL TECHNOLOGIES, CORPTerminatedUnknown
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard
Z-2076-2019 · View FDA record ↗ - ConvaTec, IncTerminatedUnknown
AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
Z-2744-2018 · View FDA record ↗
Registered firms
65 firms currently registered for this product code
Convatec, Inc.
Greensboro, NC, US
Delta Med Spa
Delebio Sondrio, IT
Teleflex Llc (nadc)
Olive Branch, MS, US
C.r. Bard, Inc.
MADISON, GA, US
Sterigenics Us Llc
Grand Prairie, TX, US
Isomedix Operations, Inc
ONTARIO, CA, US
Coopersurgical, Inc.
Trumbull, CT, US
Cook Incorporated
Spencer, IN, US
Laborie Medical Technologies Corp.
Portsmouth, NH, US
Creation Technologies Ltd
Mississauga Ontario, CA
Status Medical Equipments India Private Limited
Satara Maharashtra, IN
Alacer Industria Eletronica Ltda
Sao Paulo, BR
Teleflex Medical Llc
Morrisville, NC, US
Productos Para El Cuidado De La Salud
NOGALES Sonora, MX
Isomedix Operations, Inc.
Libertyville, IL, US
Vivachek Biotech (hangzhou) Co., Ltd
Hangzhou, Zhuji Zhejiang, CN
Guangzhou Potent Medical Equipment Joint-stock Co., Ltd.
Guangzhou Guangdong, CN
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Isomedix Operations Inc.
S Plainfield, NJ, US
Medical Measurement Systems B.v.
HENGELO Overijssel, NL
Icu Medical Healthcare Manufacturing S.a. De C.v.
APODACA Nuevo Leon, MX
C.r. Bard, Inc.
COVINGTON, GA, US
Prince Medical Sas
ERCUIS Oise, FR
510(k) clearances
36 clearances for this product code
- Srs MedicalDec 21, 2021
K212830 · CT3000Pro
- Urodynamix Technologies, Ltd.Dec 18, 2008
K082701 · URONIRS, MODEL 2000
- Laborie Medical Technologies, Corp.Mar 5, 2008
K073552 · LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
- Pelvicare, Inc.Jul 17, 2000
K001386 · ACCUSET SENSOR, MODEL 2000
- Medtronic Functional Diagnostics A/SFeb 28, 2000
K992715 · NEURO URODYNAMIC SUITE, MODEL 9032E0101
- Influence, Inc.Nov 24, 1998
K983325 · IN-PROBE II URODYNAMIC SYSTEM
- Circon VideoOct 24, 1997
K970595 · CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
- Medamicus, Inc.Jun 3, 1997
K971911 · LUMAX CYSTOMETRY ADMINISTRATION TUBE SET