Rhythmlink® RLSND131-2.5Recalls & reported problems
Rhythmlink International, LLC · 10 electrodes, 13mm long, 0.4mm diameter disposable twisted subdermal needle with touch proof connector · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816312020205), received between Sep 4, 2019 and Mar 27, 2023 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
DURING A TRANSFORAMINAL INTERBODY FUSION THE DEVICE WAS USED AS AN ULNAR STIMULATING ELECTRODE AT THE WRIST. UPON REMOVAL, THE NEEDLE BROKE AND A PIECE OF THE NEEDLE REMAINED IN THE PATIENT REQUIRING A SMALL INCISION TO REMOVE. THE PART NUMBER WAS IDENTIFIED AS (B)(4), LOT NUMBER PM00024421.
Patient problems: Foreign Body In Patient
MAUDE report 16619859 ↗InjurySep 4, 2019Appropriate Device Problem Term/Code Not Available
MEDICAL DEVICE DISTRIBUTOR REPORTS THAT A FOREIGN OBJECT WAS REMOVED FROM A PATIENT 3 DAYS AFTER SURGERY. THE REPORT WAS SUBMITTED TO RHYTHMLINK QUALITY BY RHYTHMLINK'S DISTRIBUTOR PACIFIC NEUROPHYSIOLOGICAL SYSTEMS, THROUGH RHYTHMLINK SALES DEPARTMENT BY EMAIL AND RECEIVED ON 24-JUL-2019. THE HOSPITAL WAS REPORTED TO BE CHILDREN'S HOSPITAL AT OAKLAND\UCSF. THE REPORT CONTAINED ONLY A PHOTO OF THE FOREIGN OBJECT. NO OTHER INFORMATION WAS SENT. RHYTHMLINK QUALITY WAS UNABLE TO DETERMINE FROM THE PHOTO AND LACK OF ANY OTHER INFORMATION, THAT THE OBJECT WAS A PIECE OF A NEEDLE, OR THAT THE OBJECT WAS FROM A PIECE OF RHYTHMLINK PRODUCT.
Patient problems: Foreign Body In Patient
MAUDE report 8961064 ↗
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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