Electrode, Circular (Spiral), Scalp And Applicator
FDA adverse event reports and recall history for electrode, circular (spiral), scalp and applicator (product code HGP), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 279
- Deaths
- 7
- Injuries
- 170
- Malfunctions
- 92
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-01-06Open, ClassifiedUnder Investigation by firm
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.
- 2012-11-16TerminatedEmployee error
Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
- TerminatedUnder Investigation by firm
Fetal Spiral Electrode, Model No. 9898 031 37631
During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
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