SPRINT 9244-6001B (UDI 00850022775079)Recalls & reported problems
Spr Therapeutics, Inc. · SPRINT Dual Lead Conversion Kit · Class 2
Data updated Oct 13, 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 00850022775079), received between Sep 5, 2025 and Sep 5, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Erythema1
- Inflammation1
- Purulent Discharge1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT EXPERIENCED SIGNIFICANT DISCOMFORT IN THEIR POSTERIOR THIGH AND DIFFICULTY MOVING THEIR LEG IMMEDIATELY FOLLOWING LEAD PLACEMENT THAT DID NOT IMPROVE OVER SEVERAL DAYS. PATIENT PRESENTED IN THE ER ELEVEN DAYS AFTER LEAD PLACEMENT WITH WORSENING LEG PAIN AND PERCEIVED HARDENING OF THE AREA AROUND THEIR SCIATIC LEAD. BOTH LEADS WERE REMOVED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER MONITORING AND TREATMENT OF THE INFECTION. WHILE ADMITTED, THE PATIENT WAS PRESCRIBED THREE TYPES OF ANTIBIOTICS.
Patient problems: Erythema; Inflammation; Purulent Discharge; Unspecified Infection
MAUDE report 22976793 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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