Skip to content

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

Other Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief devices

All Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page