NuVent ™ 1830707MAXRecalls & reported problems
Medtronic Xomed, Inc. · BALLOON SEEKER 1830707MAX EM MAXL 7X7MM · Class 1
Data updated Oct 13, 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 00643169770966), received between May 17, 2024 and May 17, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionMay 17, 2024Break; Break
IT WAS REPORTED THAT DURING PROCEDURE, BALLOON BROKE DURING INFLATION OF MAXILLARY AND HAD TO OPEN NEW BALLOON. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19338351 ↗
Other INSTRUMENT, ENT MANUAL SURGICAL devices
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- n.a. 738752Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 810505Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 723400Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 738750Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 738756Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 723014Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
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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