ACCLARENT PIVOT PVT0616NRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031465596), received between Aug 27, 2021 and Apr 24, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE HYBRID BALLOON SINUPLASTY (BSP) PROCEDURE WITH SHAVER, THE PHYSICIAN FELT THAT THERE WAS A VARIETY OF INACCURACIES BETWEEN THE DIFFERENT INSTRUMENTS THAT WERE USED. THE INSTRUMENTS USED WERE THE FOLLOWING: A 4.0MM ¿ 15° TRUDI NAVIGATION SHAVER BLADE (TSB415 / 240117C-PC), A 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / 2308140), A 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / 2309057), A 90° TRUDI NAV SUCTION DEVICE (TDNS090Z / 2312269), AN ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N / 82284217), AND A TRUDI NAV CABLE (TDNC001 / 240304D-PC) THAT WAS USED FOR THE SUCTIONS. HOW MUCH INACCURACY WAS OBSERVED / PRESENT COULD NOT BE CONFIRMED. THE PROCEDURE REPORTEDLY CONTINUED WITHOUT ANY TROUBLESHOOTING. THE SOFTWARE VALUE TO BE V2.3.2.3, BUT THE CALLER DID NOT HAVE THE FULL VERSION. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. NONE OF THE COMPLAINT PRODUCTS ARE AVAILABLE FOR RETURN. ON 24-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PHYSICIAN¿S OFFICE STAFF MEMBER REGISTERED THE CASE. HOW THE INACCURACY WAS DETERMINED COULD NOT BE CONFIRMED. THE INACCURACY WAS FIRST NOTICED WHEN THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177546 ↗
• MalfunctionJun 26, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE WITH SEPTOPLASTY ON (B)(6)2023, THE FOLLOWING THREE (3) ACCLARENT DEVICES WERE USED: TWO (2) ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N) FROM THE SAME LOT NUMBER (82272759) AND A 90° TRUDI NAV SUCTION DEVICE (TDNS090Z / 2212159) WERE USED. IT WAS REPORTED THAT BOTH OF THE ACCLARENT PIVOT NAVIGATION BALLOONS HAD KINKED GUIDEWIRES AND THE FRONTAL SINUS COULD NOT BE ACCESSED. BOTH PIVOT BALLOONS HAD KINKS IN THE DISTAL TIP OF THE GUIDEWIRE. THE 90° TRUDI NAV SUCTION DEVICE SHOWED A RED ERROR AND WAS NOT ABLE TO BE NAVIGATED. THE PROCEDURE WAS COMPLETED USING NEW DEVICES. THERE WERE NO NEGATIVE PATIENT IMPACT REPORTED. ALL THREE COMPLAINT DEVICES ARE NOT AVAILABLE FOR RETURN. ON 20-JUN-2023, ADDITIONAL INFORMATION WAS RECEIVED. RELATED TO THE FIRST PIVOT BALLOON, THE INFORMATION INDICATED THAT THERE WERE ACCURACY ISSUES ASSOCIATED WITH THE FIRST PIVOT BALLOON. THE GUIDEWIRE WAS NOT KINKED PRIOR TO THE PROCEDURE. THERE WAS NO ISSUE RELATED TO THE PATIENT ANATOMY THAT MAY HAVE CONTRIBUTED TO THE GUIDEWIRE BECOMING KINKED. THE BALLOON CATHETER WAS NOT KINKED. THE KINKED GUIDEWIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17205797 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE ON (B)(6) 2023, AN ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N / LOT# UNKNOWN) WAS USED. THE ACCLARENT DEVICE FUNCTIONED AS EXPECTED WITH NO INTRAOPERATIVE MALFUNCTION OR PERFORMANCE ISSUE. THE PIVOT BALLOON WAS INFLATED TWO TIMES DURING DILATION OF THE SPHENOID SINUS. IT WAS REPORTED THAT DILATION OF THE SPHENOID SINUS LED TO THE CAROTID ARTERY ¿BLOWING.¿ THE PIVOT BALLOON WAS LEFT INFLATED IN THE SINUS TO STOP THE BLEEDING. THE PATIENT WAS AMBU BAGGED AND INTUBATED THEN THE EMERGENCY MEDICAL TECHNICIANS (EMTS) ARRIVED. IT WAS REPORTED THAT ¿SHE IS DOING BETTER NOW.¿ THE PATIENT HAD NOT UNDERGONE ANY PREVIOUS SINUS PROCEDURE. THE PHYSICIAN DID NOT IDENTIFY ANY DEFECT IN THE SKULL BASE PREOPERATIVELY OR INTRAOPERATIVELY. IN THE PHYSICIAN¿S OPINION, IT WAS THE PATIENT¿S UNIQUE ANATOMY THAT CONTRIBUTED TO THE REPORTED ADVERSE EVENT. ¿THE PHYSICIAN DID NOT BLAME ACCLARENT.¿ THE ADVERSE EVENT RESULTED IN A 3-HOUR DELAY IN THE PROCEDURE. THE ADVERSE EVENT DID RESULT IN PROLONGATION OF THE PATIENT¿S HOSPITALIZATION, THE DURATION OF THE PATIENT¿S HOSPITALIZATION WAS NO

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 17084123 ↗
• MalfunctionJun 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY IN-OFFICE EUSTACHIAN TUBE BALLOON DILATION PROCEDURE, THE TIP OF THE OF THE ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N / (B)(4) FELL OFF BEFORE THE PROCEDURE STARTED. THE BALLOON WAS BEING ADVANCED TO MAKE SURE IT WAS WORKING PROPERLY AS IT EXITED THE GUIDE CATHETER. THE PIVOT NAVIGATION BALLOON WAS REPLACED AND THE PROCEDURE WAS STARTED. THERE WERE NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597541 ↗
• MalfunctionMar 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE, THE BLUE BALL TIP FELL OFF FROM THE ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N / 82232425) AFTER DILATION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR INJURY ASSOCIATED WITH THE REPORTED EVENT. THE COMPLAINT DEVICE IS AVAILABLE FOR RETURN. ON 04-MAR-2022, ADDITIONAL INFORMATION WAS PROVIDED FROM THE ACCLARENT SALES REPRESENTATIVE TO THE ACCLARENT PRINCIPAL QUALITY ENGINEER VIA PHONE. THE INFORMATION INDICATED THAT AN IMPORTANT DETAIL WAS NOT ADDED TO THE COMPLAINT. PER THE ACCLARENT SALES REPRESENTATIVE, ¿THE SCRUB TECH NEVER REMOVED THE RED PROTECTIVE SHEATH. WHEN THE DOCTOR RETRACTED THE BALLOON AND ARTICULATED TO 110 DEGREES, THE PROTECTIVE SHEATH WAS STILL ON THE BALLOON. THAT RED PROTECTIVE SHEATH WAS ALSO STILL ON THE CATHETER WHEN THE DEVICE WAS INSERTED INTO THE PATIENT.¿ ON 07-MAR-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING ALL SIX SINUSES. WHEN THE BLUE BALL TIP FELL OFF THE BALLOON, THE PROCEDURE WAS NOT YET COMPLETE, THE PHYSICIAN DILATED ONE OF THE SIX INTENDED SINUSES. THE LEFT MAX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840825 ↗
• MalfunctionMar 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, WHEN THE SCRUB TECH SNIPPED OFF THE BLUE TIP OF THE ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N / 82228108) AND TRIED TO RETRACT THE BALLOON, THE BALLOON BECAME DETACHED FROM THE DEVICE. THEN WHEN THE REPLACEMENT BALLOON, ANOTHER ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N / 82228108) WAS BEING PREPPED, THE SCRUB TECH FORGOT TO UNLOCK THE BALLOON AND THE WIRE AND WHEN SHE SNIPED THE TIP OF THE BALLOON OFF, THE WIRE WAS INADVERTENTLY SNIPPED RENDERING THE DEVICE UNUSABLE. A THIRD BALLOON WAS OPENED AND USED TO THE COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 22-FEB-2022, ADDITIONAL INFORMATION WAS PROVIDED. THE INFORMATION INDICATED THAT DURING THE FIRST INCIDENT, WHEN THE SCRUB TECH SNIPPED THE TIP AND RETRACTED THE BALLOON, THE BALLOON HAD NOT BEEN USED YET. IT WAS OUT OF THE PACKAGE SO IT WAS FULLY DEFLATED PRIOR TO RETRACTION. THE TIP WAS CUT IMMEDIATELY AFTER OPENING THE DEVICE. THE ENTIRE BALLOON COMPONENT WAS SHEARED OFF WHEN THE BALLOON WAS RETRACTED; THE ACCLARENT ENT CONSULTANT REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691425 ↗
• MalfunctionOct 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE PRIMARY BALLOON SINUPLASTY (BSP) PROCEDURE ON (B)(6) 2021, THE BLUE TIP OF THE ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N / 82223847) CAME OFF WHILE THE DEVICE WAS INSIDE THE ETHMOID SINUS. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BLUE TIP FROM THE ETHMOID SINUS VIA SUCTION. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THE PATIENT ANATOMY. A NEW BALLOON SYSTEM WAS OPENED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION DUE TO THE REPORTED ISSUE. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579757 ↗
• MalfunctionAug 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IN-OFFICE, FUNCTIONAL ENDOSCOPIC SINUS REVISION HYBRID PROCEDURE ON (B)(6) 2021, THE 2MM BULB TIP OF THE ACCLARENT PIVOT NAVIGATION BALLOON DILATION SYSTEM (PVT0616N / 82223847) BROKE OFF IN THE FRONTAL SINUS DURING SEPTOPLASTY. THE PIVOT BALLOON HAD BEEN INFLATED FOUR TIMES BEFORE THE ISSUE WITH THE BULB BREAKING OFF OCCURRED. THE BULB TIP WAS SUCCESSFULLY REMOVED VIA STERILE TWEEZERS. THE PATIENT WAS STABLE; NO HARM WAS NOTED TO THE PATIENT. THE GUIDE/BALLOON HAD NOT BEEN FLUSHED PRIOR TO USE. IT WAS ALSO REPORTED THAT THE GUIDEWIRE COMPONENT IN THE BALLOON WAS KINKED AND WOULD NOT SLIDE EASILY BACK AND FORTH. A NEW PIVOT BALLOON FROM THE SAME LOT (82223847) WAS OPENED AND USED TO COMPLETE THE CASE WITHOUT ANY FURTHER INCIDENT. THE REPORTED ISSUE RESULTED IN LESS THAN 2 MINUTES DELAY; NOT CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380853 ↗