Deflux Gel 1.0 mL SyringeRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00850004725009), received between Jun 14, 2022 and Sep 17, 2026 — classified as 14 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Break” (60 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808941 ↗
• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226073 ↗
• MalfunctionJun 23, 2026Break

  IT WAS REPORTED THAT "[PHYSICIAN] CALLED TO REPORT TWO BROKEN DEFLUX SYRINGES DURING USE. ONE OF THE DEFLUX CUT THE RIGHT INDEX FINGER OF A PHYSICIAN. THE PATIENT WAS A CHILD; PROCEDURE WAS BLADDER NECK BULKING. A DEFLUX METAL NEEDLE WAS IN USE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ADDITIONAL DEFLUX SYRINGES." TWO SYRINGES INVOLVED. ASSOCIATED MDRS: 3014909464-2026-00067.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25597492 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT "THE DEFLUX GEL FAILED TO COME OUT OF THE SYRINGE AFTER THE PLUNGER WAS PUSHED; THEREFORE, THE GEL COULD NOT GO THROUGH THE DEFLUX METAL NEEDLE. THE PATIENT WAS ABLE TO RECEIVE THEIR DEFLUX DOSE USING A THIRD SYRINGE THAT HAD NO ISSUES. THERE WERE NO MISSED DOSES OR ADVERSE EVENTS. FOR ONE OF THE SYRINGES, THE WINGS BROKE OFF, AND NONE OF THE MEDICATION CAME OUT. THE PATIENT WAS UNDER ANESTHESIA, AND THE CASE PROCEEDED WITHOUT AWAKENING THE PATIENT WITH ANOTHER SYRINGE. INDICATION FOR USE: VESICOURETER-REFLUX WITH REFLUX NEPHROPATHY WITH HYDROURETER IN A CHILD. NO PATIENT INJURY OR CONSEQUENCE REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25493937 ↗
• MalfunctionJun 5, 2026Break

  IT WAS REPORTED THAT "WHEN THE ITEM WAS TO BE UTILISED (INJECTED) IT FAILED AND BROKE OFF DURING THE PREPARATION. THIS OCCURRED ON BOTH OCCASIONS." NO INJURIES OR CONSEQUENCES REPORTED. 2 SYRINGES REPORTED. ASSOCIATED MDRS: 3014909464-2026-00053.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417979 ↗
• MalfunctionJun 5, 2026Break

  IT WAS REPORTED THAT "WHEN THE ITEM WAS TO BE UTILISED (INJECTED) IT FAILED AND BROKE OFF DURING THE PREPARATION. THIS OCCURRED ON BOTH OCCASIONS." NO INJURIES OR CONSEQUENCES REPORTED. 2 SYRINGES REPORTED. ASSOCIATED MDRS: 3014909464-2026-00054.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417147 ↗
• InjuryMay 21, 2026Break

  IT WAS REPORTED THAT "SURGEON WAS USING THE DEFLUX GEL SYRINGE AND WHEN SHE TRIED TO START PUSHING THE CONTENTS OUT, SHE WAS MET WITH MORE RESISTANCE THAN NORMAL, AND THE SYRINGE COMPLETELY SHATTERED, RESULTING IN A LACERATION ON HER FINGER. THE SURGEON USES THIS PRODUCT FREQUENTLY AND HAS NEVER HAD ISSUES WITH IT, SO SHE BELIEVES IT MIGHT BE A FAULTY LOT." ADDITIONAL INFORMATION RECEIVED ON APRIL 28, 2026, INDICATED THAT "THE PATIENT WAS UNDER ANESTHESIA, AND THE PROCEDURE COULD PROCEED WITHOUT AWAKING THE PATIENT WITH ANOTHER SYRINGE. THE DEFLUX METAL NEEDLE WAS USED. THE INDICATION WAS VUR IN A CHILD. NO INJURIES REPORTED." THE PHOTOGRAPH PROVIDED BY THE CUSTOMER SHOWS A SUPERFICIAL LACERATION ON THE FINGER.

  Patient problems: Laceration(s)

  MAUDE report 25247396 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT "DURING A CYSTOSCOPY WITH DEFLUX INJECTION PROCEDURE THE SYRINGE CONTAINING GEL BROKE OFF THE NEEDLE HEAD ON AD MINISTRATION. SURGEON REQUESTED ANOTHER IMPLANT. A SECOND & THIRD IMPLANT WAS PROVIDED PER SURGEON REQUEST AND ADMINISTERED BY HIM. THE DEFECTIVE IMPLANT WAS DOCUMENTED AS "DAMAGED" AND PIECES GIVEN TO MANAGEMENT FOR FOLLOW-UP WITH MANUFACTURER." MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAVE BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT. COMPLAINT RECEIVED AS A MEDWATCH REPORT. MDR REPORT#: MW5184023.

  Patient problems: Insufficient Information

  MAUDE report 24840829 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT "WHEN INJECTING THE DEFLUX, THE PLUNGER WAS STIFF AND THE SYRINGE BROKE. THERE WAS A CLEARLY DIFFERENT RESISTANCE THAN USUAL, AND IT WAS IMPOSSIBLE TO PUSH. THE PROCEDURE ITSELF WAS COMPLETED WITHOUT ANY PROBLEMS USING SPARE DEFLUX". ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 05, 2026, INDICATED THAT "THE PATIENT WAS UNDER ANESTHESIA, AND THE PROCEDURE PROCEEDED WITHOUT AWAKENING THE PATIENT ONCE THE EVENT OCCURRED. A DEFLUX METAL NEEDLE WAS USED. INDICATION: VESICOURETERAL REFLUX IN A PEDIATRIC PATIENT. NO INJURIES OR ADVERSE CONSEQUENCES WERE REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464249 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT "2 FAULTY DEFLUX SYRINGES. THE NURSES ENCOUNTERED THE ISSUE WHEN ATTEMPTING TO USE THE ITEM (DEFLUX), FINDING THE ITEM BROKE ON BOTH OCCASIONS. FORTUNATELY, IN EACH INSTANCE, THE ITEM NEVER MADE IT TO THE PATIENT, BUT WE WANTED TO REPORT THE ISSUE". ADDITIONAL INFORMATION RECEIVED ON JANUARY 24, 2026, INDICATED THAT THERE WERE NO INJURIES OR CONSEQUENCES, AND PICTURES SHARED SHOW ONLY 1 SYRINGE BROKEN IN THE FLANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24407822 ↗
• InjuryFeb 5, 2026Break

  IT WAS REPORTED THAT "LAST NIGHT I RECEIVED A CALL FROM A DOCTOR FROM THE (B)(6). THE DOCTOR WAS USING DEFLUX FOR A PATIENT WITH VUR (VESICOURETERIC REFLUX). SHE USED AN ALTERNATIVE NEEDLE (NOT A DEFLUX NEEDLE). THE NEEDLE BECAME CLOGGED, AND SHE TRIED TO FORCE IT THROUGH. THE SYRINGE ENDED UP BREAKING". ADDITIONAL INFORMATION RECEIVED ON JANUARY 15, 2026, INDICATED THAT "PATIENT WAS UNDER ANESTHESIA, IF A DELUXE NEEDLE WERE AVAILABLE, THE PROCEDURE COULD HAVE BEEN COMPLETED WITH ANOTHER SYRINGE. INJETAK ADJUSTABLE TIP NEEDLE 35CM WAS USED. INDICATION OF DEFLUX WAS VUR IN A CHILD. WHILE ADMINISTERING, THE GLASS SYRINGE SHATTERED AT THE PLUNGER, AND THE SURGEON WAS INJURED DUE TO THE EVENT. THE GLASS WAS REMOVED, CUTS WASHED OUT, AND BANDAGED."

  Patient problems: Laceration(s)

  MAUDE report 24270716 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT "[PHYSICIAN] WAS PERFORMING A DEFLUX CASE. [PHYSICIAN] FIRST INJECTED ONE SYRINGE OF DEFLUX. THEN, UPON INJECTING THE SECOND SYRINGE OF DEFLUX, THE GLASS COLLAR HOLDING THE FLANGE IN PLACE SNAPPED OFF. THERE WAS NO INJURY TO THE SURGEON." ADDITIONAL INFORMATION RECEIVED ON DECEMBER 21, 2025, INDICATED THAT "THE PROCEDURE PROCEEDED WITHOUT AWAKENING THE PATIENT, AND THE PROCEDURE WAS COMPLETED. ANOTHER SYRINGE WAS NOT REQUIRED AS THE ISSUE OCCURRED WHEN THE SYRINGE WAS ALMOST EMPTY. A DEFLUX METAL NEEDLE WAS USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082645 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT "WHEN WE INJECTED THE PRODUCT INTO THE SILICONE HOLDER, THE SYRINGE HOLDER BROKE IN HALF. " IN THE PHOTO, IT WAS OBSERVED THAT THE SYRINGE FLANGE WAS BROKEN. NO PATIENT HARM OR INJURY REPORTED. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAVE BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23431186 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT "WHEN PUSHING THE FINGER GRIP OF THE SYRINGE TO INJECT DEFLUX, THE FLANGE BROKE DURING USE. THEREFORE, IT WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OR THE PHYSICIAN OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080474 ↗
• InjuryJul 23, 2025Break; Break

  IT WAS REPORTED THAT "THE FINGER WING OF A SYRINGE IS BROKEN. ON THE SECOND SYRINGE, THE SCREW RING BROKE OFF AND THE MEDICATION SQUIRTED OUT IN AN UNCONTROLLED MANNER. NO APPLICATION WAS POSSIBLE." MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAVE BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT. 2 DEVICES INVOLVED. ASSOCIATED MDRS:. AND 3014909464-2025-00031.

  Patient problems: Laceration(s)

  MAUDE report 22578820 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT "THE FINGER WING OF A SYRINGE IS BROKEN. ON THE SECOND SYRINGE, THE SCREW RING BROKE OFF AND THE MEDICATION SQUIRTED OUT IN AN UNCONTROLLED MANNER. NO APPLICATION WAS POSSIBLE." MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAVE BEEN UNSUCCESSFUL AT THE TIME OF THIS REPORT. 2 DEVICES INVOLVED. ASSOCIATED MDRS:3014909464-2025-00030 .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578668 ↗
• InjuryJun 9, 2025Break; Break

  IT WAS REPORTED THAT "[PHYSICIAN] WAS PERFORMING DEFLUX IMPLANT IN ADULT VUR PATIENT. HE HAD SUCCESSFULLY IMPLANTED 2ML (2 X 1ML SYRINGES) THROUGH THE DEFLUX NEEDLE. [PHYSICIAN] ATTACHED A 3RD SYRINGE, AND AS HE WAS IMPLANTING, THE BASE OF THE GLASS SYRINGE SNAPPED OFF. THE AFFECTED SYRINGE WAS PLACED TO THE SIDE, AND A FOURTH SYRINGE WAS ATTACHED. THIS SYRINGE ALSO SNAPPED AT THE BASE, AND THE GLASS FROM THE SYRINGE SLICED OPEN THE LATERAL ASPECT OF THE SURGEON'S MIDDLE FINGER. THE INJURY WAS APPROXIMATELY 1CM LONG. THE SURGEON WAS UNABLE TO COMPLETE THE PROCEDURE DUE TO THE LAST TWO DEFLUX SYRINGES BOTH SNAPPING AT THE BASE. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT; IT WAS AN INJURY TO THE OPERATING SURGEON." SYRINGES INVOLVED 2. ASSOCIATED MDRS: 3014909464-2025-00026.

  Patient problems: Laceration(s)

  MAUDE report 22171364 ↗
• InjuryJun 9, 2025Break; Break

  IT WAS REPORTED THAT "[PHYSICIAN] WAS PERFORMING DEFLUX IMPLANT IN ADULT VUR PATIENT. HE HAD SUCCESSFULLY IMPLANTED 2ML (2 X 1ML SYRINGES) THROUGH THE DEFLUX NEEDLE. [PHYSICIAN] ATTACHED A 3RD SYRINGE, AND AS HE WAS IMPLANTING, THE BASE OF THE GLASS SYRINGE SNAPPED OFF. THE AFFECTED SYRINGE WAS PLACED TO THE SIDE, AND A FOURTH SYRINGE WAS ATTACHED. THIS SYRINGE ALSO SNAPPED AT THE BASE, AND THE GLASS FROM THE SYRINGE SLICED OPEN THE LATERAL ASPECT OF THE SURGEON'S MIDDLE FINGER. THE INJURY WAS APPROXIMATELY 1CM LONG. THE SURGEON WAS UNABLE TO COMPLETE THE PROCEDURE DUE TO THE LAST TWO DEFLUX SYRINGES BOTH SNAPPING AT THE BASE. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT; IT WAS AN INJURY TO THE OPERATING SURGEON."

  Patient problems: Laceration(s)

  MAUDE report 22171214 ↗
• MalfunctionMay 20, 2025Break; Break

  ON APRIL 29, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [DISTRIBUTOR] OF A [HOSPITAL] IN (B)(6). IT WAS REPORTED THAT "DURING THE SURGERY, THE DOCTOR CONNECTED THE SYRINGE TO THE NEEDLE. WHEN THE DOCTOR ADMINISTERED THE INJECTION, THE BACK HALF OF THE GEL SHATTERED, CAUSING TWO PIECES OF GLASS TO BREAK OFF. AFTER THAT, THE DOCTOR DISCONNECTED THE NEEDLE FROM THE SYRINGE, REPLACED IT WITH ANOTHER SYRINGE, AND WAS ABLE TO USE IT NORMALLY AGAIN." ADDITIONAL INFORMATION RECEIVED ON MAY 09, 2025, INDICATED THAT THERE WAS NO INJURY / ADVERSE EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053015 ↗
• MalfunctionMay 2, 2025Break; Break

  ON APRIL 09, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [DISTRIBUTOR] THAT WAS REPORTED FROM A [HOSPITAL] IN SPAIN. IT WAS REPORTED THAT "DURING TWO OPERATIONS IN THE CHILDREN'S OPERATING ROOM ON TWO DAYS IN A ROW, THE SYRINGE HAS BROKEN DURING THE INJECTION." ADDITIONAL INFORMATION RECEIVED ON APRIL 10, 2025, INDICATED THAT THERE WAS NO INJURY TO THE PATIENT OR THE PHYSICIAN, AND THE SYRINGES BROKE AT THE JOINT BETWEEN THE WINGS AND THE BODY OF THE SYRINGE. TWO SYRINGES ARE INVOLVED. ASSOCIATED MDRS: 3014909464-2025-00015.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955774 ↗
• MalfunctionMay 2, 2025Break; Break

  ON APRIL 09, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [DISTRIBUTOR] THAT WAS REPORTED FROM A [HOSPITAL] IN SPAIN. IT WAS REPORTED THAT "DURING TWO OPERATIONS IN THE CHILDREN'S OPERATING ROOM ON TWO DAYS IN A ROW, THE SYRINGE HAS BROKEN DURING THE INJECTION." ADDITIONAL INFORMATION RECEIVED ON APRIL 10, 2025, INDICATED THAT THERE WAS NO INJURY TO THE PATIENT OR THE PHYSICIAN, AND THE SYRINGES BROKE AT THE JOINT BETWEEN THE WINGS AND THE BODY OF THE SYRINGE. TWO SYRINGES ARE INVOLVED. ASSOCIATED MDRS: 3014909464-2025-00016.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955772 ↗
• MalfunctionApr 29, 2025Break; Break

  ON APRIL 04, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [DISTRIBUTOR] IN CANADA, IN WHICH IT WAS REPORTED THAT "THE SYRINGE BREAKS WHEN THE SURGEON PUSHES THE PLUNGER. WE HAD THE SAME PROBLEM IN SEPTEMBER 2024, ALSO ON BATCH: 20852." ADDITIONAL INFORMATION RECEIVED ON APRIL 14, 2025, INDICATED THAT THE PROCEDURE CONTINUED WITH ANOTHER SYRINGE, AND NO INJURIES WERE REPORTED. ASSOCIATED MDR REPORTS: 3014909464-2025-00013.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930763 ↗
• InjuryApr 29, 2025Break; Break

  ON APRIL 04, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [DISTRIBUTOR] IN CANADA, IN WHICH IT WAS REPORTED THAT "THE SYRINGE BREAKS WHEN THE SURGEON PUSHES THE PLUNGER. WE HAD THE SAME PROBLEM IN SEPTEMBER 2024, ALSO ON BATCH: 20852." ADDITIONAL INFORMATION RECEIVED ON APRIL 14, 2025, INDICATED THAT THE PROCEDURE CONTINUED WITH ANOTHER SYRINGE, BUT THE PHYSICIAN CUT HIS FINGER DUE TO THE BREAKAGE OF THE SYRINGE. ASSOCIATED MDR REPORTS: 3014909464-2025-00014.

  Patient problems: Laceration(s)

  MAUDE report 21930685 ↗
• MalfunctionApr 23, 2025Break; Break

  ON MARCH 26, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [DISTRIBUTOR] IN SWITZERLAND. IT WAS REPORTED THAT "THE THUMB REST OF THE PLUNGER HAS BROKEN OFF DURING USE, THEREFORE NOT ALL OF THE GEL COULD BE APPLIED. TWO SYRINGES INVOLVED." ADDITIONAL INFORMATION RECEIVED ON APRIL 01, 2025 INDICATED THAT "THERE WAS NO INJURY OR ADVERSE EVENT OTHER THAN HAVING TO TAKE NEW SYRINGES." ASSOCIATED MDR REPORTS: 3014909464-2025-00018.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896253 ↗
• MalfunctionApr 23, 2025Break; Break

  ON MARCH 26, 2025, PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION FROM A [DISTRIBUTOR] IN SWITZERLAND. IT WAS REPORTED THAT "THE THUMB REST OF THE PLUNGER HAS BROKEN OFF DURING USE, THEREFORE NOT ALL OF THE GEL COULD BE APPLIED. TWO SYRINGES INVOLVED." ADDITIONAL INFORMATION RECEIVED ON APRIL 01, 2025 INDICATED THAT "THERE WAS NO INJURY OR ADVERSE EVENT OTHER THAN HAVING TO TAKE NEW SYRINGES." ASSOCIATED MDR REPORTS: 3014909464-2025-00018 AND 3014909464-2025-00019.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896154 ↗