Cable, Transducer And Electrode, Patient, (including Connector)
Cardiovascular · 21 CFR 870.2900
Recent MDR events
622 adverse event reports on file
- Patient CableJul 29, 2026MalfunctionMedtronic, Inc.2182208-2026-46442
- DISPOSABLE SURGICAL PACING CABLE WITH CONNECTOR PINS FOR MEDTRONIC TEMPORARY PACJul 22, 2026MalfunctionRemington Medical Inc25904259
- PATIENT CABLEJul 20, 2026MalfunctionMedtronic, Inc.2182208-2026-44898
- PATIENT CABLEJul 9, 2026MalfunctionMedtronic, Inc.2182208-2026-42058
- BIPOLAR CABLEJul 9, 2026MalfunctionMedline Industries, Lp - NorthfieldMW5190477
- PATIENT CABLEJul 1, 2026MalfunctionMedtronic, Inc.2182208-2026-39847
- PATIENT CABLEJun 30, 2026MalfunctionMedtronic, Inc.2182208-2026-39574
- PATIENT CABLEJun 30, 2026MalfunctionMedtronic, Inc.2182208-2026-39575
- PATIENT CABLEJun 30, 2026MalfunctionMedtronic, Inc.2182208-2026-39576
- PATIENT CABLEJun 30, 2026MalfunctionMedtronic, Inc.2182208-2026-39577
Event type breakdown
Recalls
12 recall events for this product code
- Physio-Control, Inc.Open, ClassifiedFeb 5, 2025
LIFEPAK 35 ECG cable REF 11111-000041
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Z-1102-2025 · View FDA record ↗ - Remington Medical Inc.TerminatedApr 9, 2014
FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.
Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-).
Z-1441-2014 · View FDA record ↗ - Biosense Webster, Inc.TerminatedJan 7, 2011
CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT
When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor.
Z-0884-2011 · View FDA record ↗ - Remington Medical Inc.TerminatedAug 13, 2010
Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005
The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG.
Z-2223-2010 · View FDA record ↗ - Volcano CorpOpen, ClassifiedUnknown
MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 79
Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets.
Z-0917-2022 · View FDA record ↗ - GE Healthcare, LLCTerminatedUnknown
ECG Trunk Cables:
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
Z-1875-2019 · View FDA record ↗ - GE Healthcare, LLCTerminatedUnknown
ECG leadwire sets:
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
Z-1876-2019 · View FDA record ↗ - GE Healthcare, LLCTerminatedUnknown
Replacement leadwires with grabber ends:
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
Z-1877-2019 · View FDA record ↗ - GE Healthcare, LLCTerminatedUnknown
Leadwire sets with snap ends:
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
Z-1878-2019 · View FDA record ↗ - GE Healthcare, LLCTerminatedUnknown
Replacement ECG leadwires with snap ends
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
Z-1879-2019 · View FDA record ↗
Registered firms
312 firms currently registered for this product code
Gww
Gaertringen Baden-Wurttemberg, DE
Xinmed Sdn. Bhd.
Senai Johor, MY
Philips North America Llc
ANDOVER, MA, US
Philips North America Llc
Cambridge, MA, US
Boston Scientific Corporation
Saint Paul, MN, US
Airlife Finland Oy
Helsinki Uusimaa, FI
Curbell Medical Products, Inc.
ORCHARD PARK, NY, US
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
Conmed Corporation
WESTBOROUGH, MA, US
Technical Services For Electronics, Inc.
New Taipei City, TW
Masimo Corporation
Irvine, CA, US
Conmed Corporation
Utica, NY, US
Usocmedical
Irvine, CA, US
Kimball Solutions Jasper, Inc.
Jasper, IN, US
Phillips-medisize Costa Mesa Llc
Costa Mesa, CA, US
Boston Scientific Limited
GALWAY, IE
Philips North America Llc
Murrysville, PA, US
Lynx Medical Pennsylvania
ERIE, PA, US
Dongguan Kepler Special Cabling Company Limited
Dongguan Guangdong, CN
Isomedix Operations Inc.
SAN DIEGO, CA, US
Steris Corporation De Republica Dominicana, S.r.l.
Santo Domingo, DO
510(k) clearances
105 clearances for this product code
- Baylis Medical Technologies, Inc.Jan 18, 2026
K254114 · Baylis Connector Cable
- Drägerwerk AG & Co. KGaADec 1, 2025
K252827 · IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)
- Shanghai Draeger Medical Instrument Co., Ltd.Sep 30, 2025
K251669 · IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter
- Beijing Rongrui-Century Science & Technology Co., Ltd.May 2, 2025
K242986 · SpO2 Extension Cable
- Philips Medizin Systeme Böblingen GmbHJan 17, 2025
K243545 · Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn
- Ivy Biomedical Systems, Inc.Sep 13, 2024
K240087 · RT Carbon ECG Leads
- Stryker Physio-ControlMay 7, 2024
K240377 · LIFEPAK® ECG Cables
- Physio-Control, Inc.Apr 30, 2024
K240156 · LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)