SPRINT 80106Recalls & reported problems
Spr Therapeutics, Inc. · SPRINT MicroLead 2.0 with OnePass Introducer, Sales Box. · Class 2
- 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 00850022775093), received between Dec 22, 2025 and Dec 22, 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
- Fever1
- Pain1
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT'S LEAD WAS REMOVED DUE TO AN INFECTION IN THE KNEE. THE PATIENT WAS HOSPITALIZED FOR TREATMENT OF THE ISSUE; TREATMENT REPORTEDLY INCLUDED SURGICAL LAVAGE AND DRAINAGE OF FLUID AND IV ANTIBIOTICS.
Patient problems: Fever; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 23864476 ↗
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- SPRINT 9600-9288-6003Spr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.