Transducer, Blood-pressure, Extravascular
Cardiovascular · 21 CFR 870.2850
Recent MDR events
3,904 adverse event reports on file
- FloTrac SensorJul 31, 2026MalfunctionEdwards Lifesciences, Dr2015691-2026-17328
- ACUMEN IQJul 21, 2026MalfunctionEdwards Lifesciences Dr2015691-2026-17014
- TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3ML SQUEEZE FLUSH DEVICE, MAJul 21, 2026MalfunctionIcu Medical De Mexico, S. De R.l. De C.v.9617594-2026-00908
- ACUMEN IQ SENSORSJul 20, 2026MalfunctionEdwards Lifesciences Dr2015691-2026-16952
- VOLUMEVIEW SENSORSJul 20, 2026MalfunctionEdwards Lifesciences, Pr2015691-2026-16979
- TRANSPAC® IV 5' CABLE FOR USE WITH DISPOSABLE TRANSDUCER REUSABLE: DO NOT DISCARJul 17, 2026MalfunctionIcu Medical, Inc.1713468-2026-00002
- ACUMEN IQ SENSORSJul 17, 2026MalfunctionEdwards Lifesciences Dr2015691-2026-16928
- TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, SAFESET¿ RESERVOIR AND 60" (15Jul 16, 2026MalfunctionIcu Medical De Mexico, S. De R.l. De C.v.9617594-2026-00853
- TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED STJul 15, 2026MalfunctionIcu Medical De Mexico, S. De R.l. De C.v.9617594-2026-00846
- MEDEX SINGLE LINE PRESSURE MONITORING KITJul 14, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v1526863-2026-00147
Event type breakdown
Recalls
236 recall events for this product code
- Medline Industries, LPOpen, ClassifiedMay 8, 2026
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2141-2026 · View FDA record ↗ - Medline Industries, LPOpen, ClassifiedMay 8, 2026
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2142-2026 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedMar 21, 2025
namic convenience kits labeled as:
The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Z-1429-2025 · View FDA record ↗ - Smiths Medical Asd IncOpen, ClassifiedJan 17, 2024
Medex LOGICAL CATH LAB KIT, List Number M20754
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Z-0739-2024 · View FDA record ↗ - Smiths Medical Asd IncOpen, ClassifiedJan 17, 2024
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Z-0740-2024 · View FDA record ↗ - Smiths Medical Asd IncOpen, ClassifiedJan 17, 2024
6IN PRESSURE TUBING, List Number MX20617
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Z-0741-2024 · View FDA record ↗ - Smiths Medical Asd IncOpen, ClassifiedJan 17, 2024
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Z-0742-2024 · View FDA record ↗ - Smiths Medical Asd IncOpen, ClassifiedJan 17, 2024
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Z-0743-2024 · View FDA record ↗ - Smiths Medical Asd IncOpen, ClassifiedJan 17, 2024
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Z-0744-2024 · View FDA record ↗ - Smiths Medical Asd IncOpen, ClassifiedJan 17, 2024
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Z-0745-2024 · View FDA record ↗
Registered firms
211 firms currently registered for this product code
Bmmedical
Lelystad Flevoland, NL
Philips North America Llc
ANDOVER, MA, US
Medline Industries, Lp (northpoint Services)
Waukegan, IL, US
Tri-state De Mexico, S. De R.l. De C.v.
MEXICALI Baja California, MX
Merit Medical Uk Limited
Earley Reading, GB
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Bioxin Medical Co., Ltd
Weihai Shandong, CN
Bioptimal International Pte. Ltd.
SINGAPORE South East, SG
Sterigenics U.s., Llc
Queensbury, NY, US
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Icu Medical Czech Republic A. S.
Hranice Olomoucky Kraj, CZ
Icu Medical, Inc
Salt Lake City, UT, US
Quest Medical, Inc.
ALLEN, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Philips Electronics Ltd
Mississauga Ontario, CA
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Medline Industries (namic Division) - Glen Falls
Glens Falls, NY, US
Covidien
Lafayette, CO, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Becton, Dickinson And Company
Irvine, CA, US
Icu Medical Healthcare Manufacturing S.a. De C.v.
APODACA Nuevo Leon, MX
Supercomal Medical Products, Sdn Bhd
SUNGAI PETANI Kedah, MY
Unimed Medical Supplies Inc
Shenzhen Guangdong, CN
510(k) clearances
148 clearances for this product code
- Edwards Lifesciences, LLCMar 21, 2025
K242909 · FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
- Merit Medical Pte. , Ltd.Mar 17, 2023
K221782 · Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
- Smiths Medical Asd, Inc.Nov 9, 2017
K172458 · HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- Smiths Medical Asd, Inc.May 24, 2017
K163172 · HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- Centurion Medical Products CorporationNov 22, 2016
K161408 · Compass Cast and MAP
- Zhejiang Haisheng Medical Device Co., Ltd.Oct 31, 2016
K152472 · Disposable Pressure Transducer
- Edwards Lifesciences, LLCJan 19, 2016
K152980 · Flo Trac sensor, Volume View sensor
- Biometrix , Ltd.Sep 4, 2015
K151040 · Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer