SPRINT 9244-6001B (UDI 00850022775321)Recalls & reported problems

Spr Therapeutics, Inc. · SPRINT Dual Lead Conversion Kit with extensa XT · 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 00850022775321), received between Jun 8, 2026 and Jun 8, 2026 — 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Pain1
Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT EXPERIENCED PAIN AND A SUSPECTED INFECTION OF THEIR POPLITEAL LEAD. THE PATIENT'S LEADS WERE REMOVED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL AND PRESCRIBED ANTIBIOTICS.
Patient problems: Pain; Unspecified Infection
MAUDE report 25428730 ↗

Device details

UDI-DI	`00850022775321`
Brand	SPRINT
Model	9244-6001B
Company	Spr Therapeutics, Inc.
Product code	NHI · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 29, 2024

Device type (GMDN): Analgesic PENS system

An assembly of mains electricity (AC-powered) devices intended for the relief of chronic neuropathic pain through percutaneous electrical nerve stimulation (PENS). It typically consists of external current generator, return electrode(s), connection cables and a system probe which may be provided separately. It is intended to deliver controlled electrical impulses directly to the subcutaneous tissue (i.e., invasively) in the vicinity of a peripheral nerve. It is intended to be used by a healthcare professional in a clinical setting.

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

SPRINT Extensa, Shipping Configuration
Spr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
21 reports
SPRINT Endura, Shipping Configuration
Spr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
20 reports
SPRINT Endura, Sales Configuration
Spr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
6 reports
SPRINT Extensa, Sales Configuration
Spr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
4 reports
SPRINT 9600-9288-6003
Spr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
2 reports
SPRINT 9244-6001B
Spr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
1 report
SPRINT 80106
Spr Therapeutics, Inc. · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
1 report

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.