Rhythmlink® RLSP310Recalls & reported problems
Rhythmlink International, LLC · 20 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 00816312022247), received between Mar 14, 2024 and Mar 14, 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.
InjuryMar 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 02/22/2024, RHYTHMLINK DEVICE RLSP310, LOT R0000005918 WAS USED DURING A PROCEDURE AND SOMATOSENSORY EVOKED POTENTIAL DISAPPEARED IN ALL CHANNELS IN THE RIGHT LOWER EXTREMITY. UPON REMOVAL IT WAS NOTICED IMMEDIATELY THAT THE NEEDLE WAS MISSING FROM THE WHITE LEADWIRE AND IT WAS LATER CONFIRMED WITH XRAY THAT THE NEEDLE REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 18907443 ↗
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.