rezum M006D2201-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 08714729992547), received between Dec 5, 2019 and Sep 29, 2026 — classified as 19 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (26 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934461 ↗
• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934460 ↗
• MalfunctionSep 17, 2026Premature Activation; Retraction Problem; Use of Device Problem

  It was reported that during a Convective Radiofrequency Water Vapor Thermal Therapy, after inserting the device into the patient, the needle deployed and misfired steam. After this happened, the needle would then not retract. The physician had to then pull the nose cone pin out of the device to manually retract the needle from the patient. The procedure was completed using another delivery device. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805061 ↗
• MalfunctionSep 3, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50599916 ↗
• InjuryApr 9, 2026Positioning Failure; Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE WAS NOT RETRACTING AFTER THE FIRST TREATMENT. THE DELIVERY DEVICE WAS UNPLUGGED, AND IT RETRACTED, BUT IT WOULD NOT DEPLOY. ANOTHER DELIVERY DEVICE HAD TO BE OPENED. THE PROCEDURE COULD NOT BE COMPLETED BECAUSE IT WAS TOO PAINFUL FOR THE PATIENT. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: Intraoperative Pain

  MAUDE report 24825332 ↗
• MalfunctionApr 3, 2026Retraction Problem

  IT WAS REPORTED THAT, DURING THE WATER VAPOR THERMAL THERAPY PROCEDURE, THE NEEDLE FAILED TO RETRACT. IT WAS NOTED THAT THE PATIENT WAS SHOWING A LITTLE DISCOMFORT DURING THE PROCEDURE, SO THE PHYSICIAN DECIDED TO FINISH THE PROCEDURE. THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY DEVICE BY PULLING THE NEEDLE SAFETY PIN AND MANUALLY RETRACTING THE NEEDLE. THERE WERE NO FURTHER PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 24783593 ↗
• MalfunctionMar 30, 2026Contamination; Unsealed Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PREPARATION, UPON OPENING THE PACKAGE TO BEGIN SET-UP, IT WAS DISCOVERED THAT THE SEAL ON THE SYRINGE WAS BROKEN AND APPEARED TO BE CONTAMINATED. A NEW DELIVERY DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24737547 ↗
• MalfunctionMar 16, 2026Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE COULD NOT BE RETRACTED. THE MANUAL RETRACTION WAS ATTEMPTED, BUT IT DID NOT RESPOND. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607837 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY UNDERWENT A CONVECTIVE RADIOFREQUENCY WATER VAPOR THERMAL THERAPY, AND NOW THE PATIENT IS EXPERIENCING URINARY INCONTINENCE. IT IS BELIEVED THAT THE EITHER THE DEVICE OR THE TECHNIQUE CONTRIBUTED TO THE SYMPTOM EXPERIENCED BY THE PATIENT. A CATHETER WAS USED BUT THE ISSUE IS STILL ONGOING.

  Patient problems: Urinary Incontinence

  MAUDE report 24598644 ↗
• MalfunctionMar 11, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE TIP OF THE DELIVERY DEVICE HAD SOMETHING IN IT THAT WAS BLOCKING VISUALIZATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571701 ↗
• MalfunctionFeb 24, 2026Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE WOULDN'T RETRACT WHEN CONNECTING THE DEVICE TO THE GENERATOR. THE DEVICE WAS DISCONNECTED AND RECONNECTED, BUT IT DID NOT WORK. MANUAL RETRACTION WAS ATTEMPTED BUT IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24425609 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST A WATER VAPOR THERAPY PROCEDURE, ONE WEEK AFTER THE CATHETER WAS REMOVED, ON THE FOLLOWING DAY, THE PATIENT EXPERIENCED UROSEPSIS. THE PATIENT WAS HOSPITALIZED AND TREATED WITH IV ANTIBIOTICS. THE PATIENT IS NOW FULLY RECOVERED. THE INFECTION WAS NOT CONTRIBUTED BY THE DEVICE BUT WAS POSSIBLY RELATED TO THE PROCEDURE.

  Patient problems: Sepsis

  MAUDE report 24064109 ↗
• MalfunctionJan 7, 2026Mechanical Problem

  IT WAS REPORTED THAT THIS DELIVERY DEVICE WAS NOT WORKING. WHEN DEVICE WAS PLUGGED IN, IT IMMEDIATELY POPS UP ERROR 255 (DELIVERY DEVICE IS PERMANENTLY DISABLED.) DUE TO THIS EVENT THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23994326 ↗
• MalfunctionNov 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE SUPPLY TEAM RECEIVED A BOX OF 5 REZUM KITS UPON ARRIVAL, THE SUPPLY TEAM EXAMINED THE KITS WITHOUT OPENING THEM AND NOTICED MOISTURE IN THE PLUNGER. THE PROCEDURES WERE CANCELLED UNTIL FUTURE NOTICE DUE TO THE DAMAGED PRODUCT UPON ARRIVAL AT THE FACILITY. THERE WERE NO PATIENT COMPLICATIONS. DEVICE 2 OF 5

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589184 ↗
• MalfunctionNov 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE SUPPLY TEAM RECEIVED A BOX OF 5 REZUM KITS UPON ARRIVAL, THE SUPPLY TEAM EXAMINED THE KITS WITHOUT OPENING THEM AND NOTICED MOISTURE IN THE PLUNGER. THE PROCEDURES WERE CANCELLED UNTIL FUTURE NOTICE DUE TO THE DAMAGED PRODUCT UPON ARRIVAL AT THE FACILITY. THERE WERE NO PATIENT COMPLICATIONS. DEVICE 4 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589182 ↗
• MalfunctionNov 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE SUPPLY TEAM RECEIVED A BOX OF 5 REZUM KITS UPON ARRIVAL, THE SUPPLY TEAM EXAMINED THE KITS WITHOUT OPENING THEM AND NOTICED MOISTURE IN THE PLUNGER. THE PROCEDURES WERE CANCELLED UNTIL FUTURE NOTICE DUE TO THE DAMAGED PRODUCT UPON ARRIVAL AT THE FACILITY. THERE WERE NO PATIENT COMPLICATIONS. DEVICE 3 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589180 ↗
• MalfunctionNov 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE SUPPLY TEAM RECEIVED A BOX OF 5 REZUM KITS UPON ARRIVAL, THE SUPPLY TEAM EXAMINED THE KITS WITHOUT OPENING THEM AND NOTICED MOISTURE IN THE PLUNGER. THE PROCEDURES WERE CANCELLED UNTIL FUTURE NOTICE DUE TO THE DAMAGED PRODUCT UPON ARRIVAL AT THE FACILITY. THERE WERE NO PATIENT COMPLICATIONS. DEVICE 1 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589177 ↗
• MalfunctionNov 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE SUPPLY TEAM RECEIVED A BOX OF 5 REZUM KITS UPON ARRIVAL, THE SUPPLY TEAM EXAMINED THE KITS WITHOUT OPENING THEM AND NOTICED MOISTURE IN THE PLUNGER. THE PROCEDURES WERE CANCELLED UNTIL FUTURE NOTICE DUE TO THE DAMAGED PRODUCT UPON ARRIVAL AT THE FACILITY. THERE WERE NO PATIENT COMPLICATIONS. DEVICE 5 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589170 ↗
• MalfunctionOct 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, UPON INSPECTION OF INVENTORY, THE STAFF NOTICED A CONDENSATION OR LUBE-LIKE SUBSTANCE IN THE PLUNGER PIECE IN THE REZUM KIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363573 ↗
• MalfunctionOct 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, UPON INSPECTION OF INVENTORY, THE STAFF NOTICED A CONDENSATION OR LUBE-LIKE SUBSTANCE IN THE PLUNGER PIECE IN THE REZUM KIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363566 ↗
• MalfunctionOct 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, UPON INSPECTION OF INVENTORY, THE STAFF NOTICED A CONDENSATION OR LUBE-LIKE SUBSTANCE IN THE PLUNGER PIECE IN THE REZUM KIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363477 ↗
• MalfunctionOct 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, UPON INSPECTION OF INVENTORY, THE STAFF NOTICED A CONDENSATION OR LUBE-LIKE SUBSTANCE IN THE PLUNGER PIECE IN THE REZUM KIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363476 ↗
• MalfunctionOct 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, UPON INSPECTION OF INVENTORY, THE STAFF NOTICED A CONDENSATION OR LUBE-LIKE SUBSTANCE IN THE PLUNGER PIECE IN THE REZUM KIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363475 ↗
• MalfunctionOct 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, UPON INSPECTION OF INVENTORY, THE STAFF NOTICED A CONDENSATION OR LUBE-LIKE SUBSTANCE IN THE PLUNGER PIECE IN THE REZUM KIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363474 ↗
• MalfunctionOct 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON INSPECTION OF INVENTORY, THE STAFF NOTICED A CONDENSATION OR LUBE-LIKE SUBSTANCE IN THE PLUNGER PIECE IN THE REZUM KIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363473 ↗