RELIEVA SPIN RS0516FRecalls & reported problems
Acclarent, Inc. · RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 5x16 F-70 GUIDE KIT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705031206304), received between Mar 26, 2018 and Mar 26, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hearing Loss1
- Tinnitus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCLARENT WAS INFORMED ON 3/8/2018, OF AN EVENT THAT TOOK PLACE IN (B)(6) 2016, WHEN THE SURGEON PERFORMED A EUSTACHIAN TUBE DILATION PROCEDURE USING THE RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 5X16MM, F-70 GUIDE KIT (RS0576F / LOT# NOT AVAILABLE) OFF-LABEL AND THE PATIENT HAS HEARING LOSS AND TINNITUS AFTER THE PROCEDURE. THE SYMPTOMS HAVE NOT IMPROVED OVER THE PAST SIX MONTHS. THERE WAS NO REPORT OF ANY MALFUNCTIONS WITH THE ACCLARENT DEVICE USED DURING THE PROCEDURE.
Patient problems: Hearing Loss; Tinnitus
MAUDE report 7372136 ↗
Other INSTRUMENT, ENT MANUAL SURGICAL devices
- n.a. 738756Karl 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. 723014Karl 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. 810506Karl 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. 738758Karl 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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