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NC SPRINTER® NCSP27515XRecalls & reported problems

Medtronic, Inc. · BALLOON NCSP27515X NCSPRINTER RX M US · Class 2

All models of NC SPRINTER (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169282377), received between Aug 3, 2021 and Aug 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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.

Most reported problems

Device problems

  • Deflation Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 3, 2021Deflation Problem; Deflation Problem

    IT WAS INTENDED TO USE A NC SPRINTER RX BALLOON. IT WAS REPORTED THAT THE BALLOON DID NOT DEFLATE AT THE LESION SITE DURING A SUBSEQUENT INFLATION. NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12265953 ↗

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Sources and updates

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