Rhythmlink® RLSND121-2.5Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00816312020144), received between Dec 17, 2018 and Jun 26, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).
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 Component5
- Break1
Patient problems
- Foreign Body In Patient4
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024, RHYTHMLINK DEVICE RLSND121-1.5, LOT PM00028655 WAS USED DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION AND THE NEEDLE "SNAPPED OFF AT HUB" THE SURGEON WAS ABLE TO REMOVE THE NEEDLE. IT WAS REPORTED THAT THE STIMULATION LEAD BEING USED ON THE PATIENT'S ANKLE.
Patient problems: Foreign Body In Patient
MAUDE report 19619654 ↗InjuryMar 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024, RLSND121-2.5, LOT PM00027786 A PAIRED NEEDLE WAS USED DURING A PROCEDURE IN WHICH STIMULATION WAS BEING APPLIED TO THE LEFT ANKLE, UPON COMPLETION OF THE STUDY THE NEEDLES WERE BEING REMOVED AND IT WAS VISUALLY IDENTIFIED THAT ONE OF THE NEEDLES REMAINED RETAINED IN THE PATIENT. THE PATIENT WAS REMOVED FROM THE OR AND AN XRAY WAS TAKEN IN PACU AND THE CLINICIAN WAS ABLE TO REMOVE THE NEEDLE FROM THE PATIENTS ANKLE WITHIN A FEW MINUTES.
Patient problems: Foreign Body In Patient
MAUDE report 18907282 ↗InjuryNov 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER REPORTED THAT SUBDERMAL NEEDLE ELECTRODES WERE USED DURING A LUMBAR FUSION PROCEDURE. FOLLOWING PROCEDURE, USER REMOVED THE SUBDERMAL NEEDLE ELECTRODES AND DISCARDED. IN POST-OP IT WAS IDENTIFIED THAT ONE OF THE NEEDLE ELECTRODES REMAINED IN THE PATIENT'S THIGH AND WAS REMOVED WITH FORCEPS. DURING COMPLAINT INVESTIGATION, THE USER NOTED THAT THE NEEDLE APPEARED TO BE INTACT BUT DETACHED FROM THE LEADWIRE. THE PART NUMBER WAS IDENTIFIED AS RLSND121-2.5, LOT NUMBER PM00023274.
Patient problems: Foreign Body In Patient
MAUDE report 15853703 ↗InjuryJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
Patient problems: Foreign Body In Patient
MAUDE report 14654295 ↗InjuryDec 17, 2018Break; Detachment of Device or Device Component
HOSPITAL REPORTS THAT A NEEDLE HAS BROKEN OFF IN A PATIENT. THE REPORT WAS SUBMITTED TO RHYTHMLINK QUALITY THROUGH RHYTHMLINK SALES DEPT BY PHONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8174684 ↗
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
- NA 8227411Medtronic Xomed, Inc. · ELECTRODE, NEEDLE4 reports
- Rhythmlink® RLSP503Rhythmlink International, LLC · Electrode, Needle3 reports
- NA 8227410Medtronic Xomed, Inc. · ELECTRODE, NEEDLE2 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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