RELIEVA ULTIRRA BC0716RURecalls & reported problems
Acclarent, Inc. · RELIEVA ULTIRRA SINUS BALLOON CATHETER 7x16 · Class 1
Data updated Oct 18, 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 10705031200289), received between May 17, 2018 and May 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2018Burst Container or Vessel
BALLOON USED FOR SINUPLASTY BUSTED WHILE IN USE ON INITIAL INFLATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7525332 ↗
Other INSTRUMENT, ENT MANUAL SURGICAL devices
- n.a. 738756Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 738752Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 723014Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 738758Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 810506Karl 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. 810505Karl 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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