SPRINT 9600-9288-6003Recalls & reported problems
Spr Therapeutics, Inc. · SPRINT extensa XT PNS System, Shipping Configuration · 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 00850022775208), received between Jan 10, 2025 and May 29, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Pain2
- Bacterial Infection1
- Cellulitis1
- Fluid Discharge1
- Purulent Discharge1
- Skin Inflammation/ Irritation1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT EXPERIENCED AN INFECTION IN THEIR KNEE AND WAS HOSPITALIZED FOR WOUND DEBRIDEMENT. LEAD WAS REMOVED AND PATIENT WAS PRESCRIBED IV AND ORAL ANTIBIOTICS. PATIENT SINCE DISCHARGED AND FEELING BETTER.
Patient problems: Fluid Discharge; Pain; Unspecified Infection
MAUDE report 22109124 ↗InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT EXPERIENCED AN INFECTION OF THEIR RIGHT LEAD EXIT SITE AT TWO DIFFERENT TIME POINTS DURING TREATMENT TARGETING THE OCCIPITAL NERVE. SUBJECT WENT TO ED AND WAS ADMITTED TO HOSPITAL. PATIENT'S LEADS WERE REMOVED AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Bacterial Infection; Cellulitis; Pain; Purulent Discharge; Skin Inflammation/ Irritation
MAUDE report 21129026 ↗
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- SPRINT Endura, Sales ConfigurationSpr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief6 reports
- SPRINT Extensa, Sales ConfigurationSpr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief4 reports
- SPRINT 80106Spr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief1 report
- SPRINT 9244-6001BSpr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief1 report
- SPRINT 9244-6001BSpr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief1 report
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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