Rhythmlink® RLSP503Recalls & reported problems
Rhythmlink International, LLC · 12 electrodes, 13mm long, 0.4mm diameter disposable paired subdermal needle with touch proof connector · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816312022421), received between May 7, 2022 and Jan 29, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Foreign Body In Patient2
- Burn(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE DATE OF THE EVENT IS UNSPECIFIED. DURING A CAROTID ENDARTERECTOMY, A RHYTHMLINK DEVICE (RLSP503, LOT NUMBER UNKNOWN) WAS USED, AND IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE LEADWIRE AND WAS LEFT IN THE PATIENT'S ARM. THE NEEDLE WAS DISCOVERED AFTER CLOSURE AND WAS REMOVED USING TWEEZERS. IMAGES WERE TAKEN TO CONFIRM THAT NO FRAGMENTS OF THE NEEDLE REMAINED.
Patient problems: Foreign Body In Patient
MAUDE report 21263584 ↗InjuryJan 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE DATE OF THE EVENT IS UNKNOWN, BUT DURING A POSTERIOR SPINAL FUSION PROCEDURE (T2-L4) LASTING 11-12 HOURS, A RHYTHMLINK DEVICE (RLSP503, LOT NUMBER UNKNOWN) WAS USED. AFTER THE REMOVAL OF THE NEEDLES, SKIN DISCOLORATION WAS NOTICED ON THE PATIENT'S SKIN, BUT NO NEEDLE WAS OBSERVED IN THE AREA. THE FOLLOWING DAY, IT WAS DISCOVERED THAT A PORTION OF THE NEEDLE HAD REMAINED IN THE PATIENT'S WRIST AREA. THE DEVICE AND NEEDLE FRAGMENT WERE DISCARDED BY THE USER FACILITY AND, AS A RESULT, COULD NOT BE RETURNED FOR EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 21263398 ↗InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Patient problems: Burn(s)
MAUDE report 14320314 ↗
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® RLSND131-2.5Rhythmlink International, LLC · Electrode, Needle2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.