Cable, Electrode
Physical Medicine · 21 CFR 890.1175
Recent MDR events
459 adverse event reports on file
- SensiTherm¿ Power AdaptorJul 31, 2026MalfunctionAbbott Medical3005334138-2026-00394
- CARTO¿ 3 System Interface Cable,34Jul 31, 2026MalfunctionMedline Renewal3032391-2026-00064
- KendallJul 28, 2026MalfunctionCardinal Health 200, Llc1423537-2026-00247
- BTP-1000AJul 16, 2026InjuryBraemar Manufacturing, Llc2133409-2026-00125
- BTP-1000AJul 16, 2026InjuryBraemar Manufacturing, Llc2133409-2026-00127
- DISPPATCBL 2.0 6FT W 8PKJul 16, 2026MalfunctionA&e Medical Corporation0002242056-2026-00009
- BTP-1000AJul 16, 2026InjuryBraemar Manufacturing, Llc2133409-2026-00128
- ECG CABLES AND LEADSETSJul 15, 2026MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2026-101408
- BTP-1000AJul 7, 2026InjuryBraemar Manufacturing, Llc2133409-2026-00123
- BTP-1000AJul 2, 2026InjuryBraemar Manufacturing, Llc2133409-2026-00111
Event type breakdown
Recalls
11 recall events for this product code
- Stryker Sustainability SolutionsOpen, ClassifiedAug 20, 2024
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.
Z-2689-2024 · View FDA record ↗ - Oscor, Inc.TerminatedApr 10, 2017
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series.
The Reusable Oscor ATAR extension cables could separate from the connector during use.
Z-2340-2017 · View FDA record ↗ - Oscor, Inc.TerminatedApr 10, 2017
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series.
The Reusable Oscor ATAR extension cables could separate from the connector during use.
Z-2733-2017 · View FDA record ↗ - Ad-Tech Medical Instrument CorporationTerminatedApr 15, 2016
Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models:
Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech electrodes for the purpose of connecting these electrodes to third party monitors/stimulators. This recall has been initiated due to package failures (i.e. compromised sterile barriers) that were identified during the execution of a shipping simulation investigation.
Z-1503-2016 · View FDA record ↗ - St. Jude MedicalTerminatedAug 5, 2011
Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only, St Jude Medical, 14901 DeVeau Place, Minnetonka, M
St. Jude Medical is recalling a single lot (3334664) of Supreme Electrophysiology Extension Cable which were packaged with a Quadripolar cable instead of a hexapolar Cable. St. Jude Medical has determined that the incorrectly labeled product poses no safety risk since the extension cable can be safely used with a corresponding Quadripolar catheter but cannot be incorrectly connected to a Hexapolar catheter.
Z-2955-2011 · View FDA record ↗ - Vermed, Inc.TerminatedMay 4, 2011
HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton
Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination.
Z-2136-2011 · View FDA record ↗ - Sterilmed IncTerminatedJan 13, 2009
EP Cables
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
Z-0554-2009 · View FDA record ↗ - GE Healthcare, LLCTerminatedUnknown
Integrated ECG cable with 3-lead leadwires labeled as the following:
The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.
Z-1060-2019 · View FDA record ↗ - Ad-Tech Medical Instrument CorporationTerminatedUnknown
Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
Incorrect version of labels were used.
Z-2494-2021 · View FDA record ↗ - Ad-Tech Medical Instrument CorporationTerminatedUnknown
Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
Incorrect version of labels were used.
Z-2495-2021 · View FDA record ↗
Registered firms
224 firms currently registered for this product code
Pmt Corp.
CHANHASSEN, MN, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Philips North America Llc
ANDOVER, MA, US
Dongguan Kepler Special Cabling Company Limited
Dongguan Guangdong, CN
Boston Scientific Corporation
Mississauga Ontario, CA
Spes Medica S.p.a
BATTIPAGLIA Salerno, IT
Circa Scientific, Inc.
Englewood, CO, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Baylis Medical Technologies Inc.
Mississauga Ontario, CA
Irvine Biomedical. Inc.
IRVINE, CA, US
Path
Germering Bavaria, DE
Technomed Europe
Kerkrade Limburg, NL
Shaoxing Dl Healthcare Co., Ltd.
Shaoxing Zhejiang, CN
Platinum Focus Group Ltd.
London London, City of, GB
Technomed Asia, Pt.
Bandung Jawa Barat, ID
Med-dyne
LOUISVILLE, KY, US
Oscor Inc.
PALM HARBOR, FL, US
Integra Lifesciences (ireland) Limited
SRAGH TULLAMORE Offaly, IE
St. Jude Medical, Atrial Fibrillation Division, Inc.
Minnetonka, MN, US
Stryker Sustainability Solutions
Tempe, AZ, US
Atl Technology Dg,ltd.
Dongguan Guangdong, CN
Dj Orthopedics De Mexico, S.a. De C.v.
TIJUANA Baja California, MX
Kego Corporation
London Ontario, CA
Chongqing Rob Linka Science And Technology Co., Ltd.
Chongqing, CN
P1 Technologies, Inc.
Cave Spring, VA, US
510(k) clearances
6 clearances for this product code
- Oscor, Inc.Jun 7, 2007
K070926 · ELECTRODE/EXTENSION CABLES, MODELS ATAR
- Therapy Equipment, Inc.Oct 13, 1999
K992372 · THE LEADAWAY
- Physiometrix, Inc.Dec 23, 1993
K935260 · PHYSIOMETRIX CABLE ADAPTER MODIFICATION
- Chemfet Corp.Nov 9, 1987
K873361 · LIFE-SPAN CABLE
- Quinton, Inc.Jan 30, 1984
K834583 · CLEAR LEADS-RADIOTRANSPARENT WIRES
- R2 Corp.May 20, 1980
K800934 · R2 ESU CABLE-ADAPTER MODELS 160,161