Rhythmlink® RLBTP201-2.5Recalls & reported problems
Rhythmlink International, LLC · Tapered Ball Tip Stimulating Probe · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00816312020823), received between Aug 5, 2021 and Aug 5, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fatigue1
- Nerve Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE A PATIENT UNDERWENT L4/5 MICRODISCECTOMY PROCEDURE. POSTOPERATIVELY THE SURGEON NOTED THE POSTERIOR SPINE DECOMPRESSIONS WHEREBY THE PATIENT HAS DEVELOPED CAUDA EQUINA SYNDROME WITH BILATERAL ABDUCTOR WEAKNESS. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) MMG BALL TIP PFR. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).
Patient problems: Fatigue; Nerve Damage
MAUDE report 12281499 ↗
Other Stimulator, Nerve devices
- NIM Vital NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls260 reports
- NIM TriVantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls176 reports
- NIM® 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall1 death167 reports
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, NERVE3 recalls45 reports
- NIM Trivantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall142 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall138 reports
- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 reports
- NIM-Response® 8253002Medtronic Xomed, Inc. · STIMULATOR, NERVE171 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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