Electrode, Electrocardiograph

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2015-11-18TerminatedNonconforming Material/Component

  ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02 58872 EF Medica FS 50 LG 50359Ultragel FS50LG

  There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date.

• 2015-03-28TerminatedNonconforming Material/Component

  Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.

  The electrodes may fail to transmit signals.

• 2011-03-02TerminatedNonconforming Material/Component

  Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003; Softrace Pediatric Wire Attached, Catalog Number: 2331-003; Softrace Limb Band, Catalog Number: 2310-003; TRU-LINK ECG Electrode (Neonatal Pre-Wired), Catalog Number: 685-0037-00; for use with electrocardiographic monitoring equipment to detect neonatal/pediatric heart action voltages.

  Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.

• 2010-09-07TerminatedProcess control

  3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring.

  The sensing element of the 3M Red Dot Monitoring Electrode, Catalog # 2560 and Novaplus Universal Monitoring Electrode #V2560 may have corrosion. In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and provide a delayed or no trace response.

• 2010-06-07TerminatedProcess control

  The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.

  Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. The user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable results is low.

• 2010-04-22TerminatedProcess design

  Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring

  In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.

• 2003-08-27TerminatedOther

  1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 unit per pouch/30 per box); Cat No 1680-003 (3 units per pouch/30 per box); Cat No 1680-005 (5 units per pouch/50 per box); and Cat No 1680-030 (30 units per pouch/no box). The electrodes are packaged 600 units/case. Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York

  Separation of the sensing element from the body of the electrode.

• 2003-08-27TerminatedOther

  1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1690-001 (1 unit per pouch/30 per box); 1690-003 (3 units per pouch/30 per box); 1690-005 (5 units per pouch/50 per box); 1690-010 (50 units per pouch/no box/ 1000 per case); 1690-030 (30 units per pouch/no box). The above are sold in boxes of 600 with the exception of 1690-010 (sold 1000 per case) as noted above. Responsible firm on the label: Conmed Corp., 310 Broad St., Utica, New York

  Separation of the sensing element from the body of the electrode.

• TerminatedProcess control

  3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.

  Potential for breakage of the ECG electrode carbon stud from the eyelet.

• TerminatedProcess control

  Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).

  Corrosion could cause performance failures in the product.