Rhythmlink® RLSND121-1.5Recalls & reported problems
Rhythmlink International, LLC · 10 electrodes, 13mm long, 0.4mm diameter disposable paired subdermal needle with touch proof connector · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816312020137), received between Oct 6, 2023 and Oct 6, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A CARTOID ENDARTERECTOMY (CEA) A SUBDERMAL NEEDLE ELECTRODE (13MM NEEDLE) DISLODGED IN POSTERIOR RIGHT CALF. THE USER NOTED THAT THE NEEDLE WAS REMOVED BY FIRST REMOVING THE TAPE COVERING THE NEEDLE, FOLLOWED WITH REMOVAL OF THE NEEDLE FROM THE PATIENT. THE USER NOTED THAT THE NEEDLE TIP WAS DETACHED FROM THE ELECTRODE AND REMAINED IN THE PATIENT. A SMALL SKIN INCISION WAS MADE AFTER CLEANSING THE SKIN WITH BETADINE. LIMITED WOUND EXPLORATION AND ULTRASOUND COULD NOT LOCALIZE THE NEEDLE TO REMOVE IT. TWO SKIN CLOSURE STITCHES WITH 4-0 MONOCRYL WERE PLACED AND DERMABOND WAS APPLIED. AN XRAY WAS PERFORMED. THE DECISION WAS MADE TO LEAVE THE NEEDLE IN THE PATIENT UNTIL A FUTURE SURGERY IS PERFORMED TO ADDRESS THIS FOREIGN BODY AT A FOLLOW-UP APPOINTMENT IF THE NEEDLE TIP IS CAUSING DISCOMFORT OR PAIN. THE USER NOTED SOME POTENTIAL CONCERN FOR ELECTRODE CONTINUITY DURING STIMULATION, AND NOTED THERE WAS SOME CURRENT RETURN ISSUES IN THE RIGHT LEG DURING THE CASE WHEN PARALYTIC HAD WORN OFF AND PATIENT WAS MOVING LEGS WITH STIMULATION. WHEN ANESTHESIA HAD REDOSED PARALYTIC, THE CURRENT RETURN RECOVERED, AND THE STIMULATION APPEARED TO BE WORKING AS NORMAL THROUGHOUT REMAINDER OF
Patient problems: Foreign Body In Patient
MAUDE report 17886875 ↗
Other Electrode, Needle devices
- Technomed Europe TE/S50715-002Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Neurosign V4 5888-00Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Technomed Europe TE/S50715-003Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Technomed Europe TE/S50725-002-CTechnomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Technomed Europe TE/S50725-002Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Rhythmlink® RLSND121-2.5Rhythmlink International, LLC · Electrode, Needle5 reports
- NA 8227411Medtronic Xomed, Inc. · ELECTRODE, NEEDLE4 reports
- Rhythmlink® RLSP503Rhythmlink International, LLC · Electrode, Needle3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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