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RELIEVA TRACT RT1640AZRecalls & reported problems

Acclarent, Inc. · RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM - 1PK · Class 1

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 20705031462653), received between Sep 1, 2021 and Sep 1, 2021 — 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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hyporesponsive to stimuli1

Recent adverse event reports

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

  • InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE HEALTHCARE PROFESSIONAL REPORTED THAT THE (B)(6) FEMALE PATIENT WITH A HISTORY OF HYPOTHYROIDISM UNDERWENT PRIMARY PROCEDURES IN THE FOLLOWING ORDER: BILATERAL PARTIAL INFERIOR TURBINATE REDUCTION, BALLOON SEPTOPLASTY, IMAGE GUIDANCE, BILATERAL FRONTAL BALLOON SINUPLASTY, BILATERAL SPHENOID BALLOON SINUPLASTY, BILATERAL MAXILLARY BALLOON SINUPLASTY ENDING WITH BILATERAL FRONTAL PROPEL CONTOUR PLACEMENT AND POSISEP X PLACEMENT ADJACENT TO THE TURBINATE INCISIONS ON (B)(6) 2021, USING THE 16 X 40 MM RELIEVA TRACT BALLOON DILATION SYSTEM (RT1640AZ / UNKNOWN LOT#) SUFFERED FROM INSTANT, PERSISTING NUMBNESS AND SENSORY LOSS IN THE HARD / SOFT PALATE. THE PATIENT WAS PLACED ON ORAL STEROID PREDNISONE AND IT WAS DISCUSSED WITH THE PHYSICIAN OF A POSSIBLE NEUROLOGICAL CONSULTATION VERSUS POSSIBLY STARTING THE PATIENT ON GABAPENTIN TO HELP REDUCE THE SENSORY NERVE IRRITATION. THE PATIENT IS CURRENTLY IN STABLE CONDITION WITH PERSISTENT PALATE NUMBNESS. DURING THE PROCEDURE, IT WAS REPORTED THAT WHILE THE RELIEVA TRACT BALLOON WAS BEING INFLATED IN THE PATIENT¿S RIGHT-SIDE SEPTUM, THE PATIENT ¿JUMPED¿ AND STATED THAT SHE FELT PAIN THEN NUMBNESS IN THE HARD / SOFT PALATE. THE BALLOON CATH

    Patient problems: Hyporesponsive to stimuli

    MAUDE report 12410529 ↗

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