Rhythmlink® RLSND122-2.5Recalls & reported problems
Rhythmlink International, LLC · 10 electrodes, 13mm long, 0.4mm diameter disposable paired subdermal needle with touch proof connector · Class 2
- 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 00816312020175), received between Jun 26, 2024 and Jun 26, 2024 — 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. How this data works · Data updated Oct 13, 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.
InjuryJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024, RHYTHMLINK DEVICE RLSND122-2.5, LOT UNKNOWN WAS BEING USED DURING A OBLIQUE LUMBAR INTERBODY FUSION AND THE NEEDLE "SNAPPED OFF," THE CLINICIAN REMOVED NEEDLE WITH TWEEZERS. IT WAS REPORTED THAT THE STIMULATION LEAD WAS USED ON THE PATIENT'S ANKLE.
Patient problems: Foreign Body In Patient
MAUDE report 19619638 ↗
Other Electrode, Needle devices
- 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/S50715-002Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Technomed Europe TE/S50725-002Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Neurosign V4 5888-00Technomed 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.