PIRANHARecalls & reported problems across all models
Richard Wolf GmbH · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 0
We found 6 models of PIRANHA by Richard Wolf GmbH in the FDA's device registry (GUDID). Together they are named in 66 adverse event reports in the FDA's MAUDE database, received between Oct 4, 2018 and Sep 22, 2026 — classified as 25 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (34 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PIRANHA problems
Device problems
- Suction Failure34
- Suction Problem16
- Decrease in Suction9
- Overheating of Device6
- Unexpected Shutdown2
- Appropriate Device Problem Term/Code Not Available1
- Collapse1
- Complete Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- Insufficient Information14
- No Consequences Or Impact To Patient3
- Laceration(s)2
- No Known Impact Or Consequence To Patient1
PIRANHA models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PIRANHA 2208011APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED54 reports
- PIRANHA 2030108APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED4 reports
- PIRANHA 41702208INSTRUMENT, ENT MANUAL SURGICAL3 reports
- PIRANHA 49700103Resectoscope2 reports
- PIRANHA 2208121APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED2 reports
- PIRANHA 49700113Resectoscope1 report
Recent PIRANHA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859655 ↗MalfunctionJun 30, 2026Suction Problem
THE DOCTOR REPORTED THAT THE SUCTION PRESSURE ON THE PIRANHA DEVICE WAS INSUFFICIENT DURING THE PROCEDURE AND CLAIMED THAT THE SUCTION WAS NOT FUNCTIONING TO ITS HIGHEST STANDARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25669519 ↗MalfunctionApr 15, 2026Suction Problem
DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, THE DOCTOR REPORTED THAT WHEN USING THE PIRANHA FUNCTION, THE MACHINE KEPT SUCKING IN A LOT OF AIR AND RESETTING. IMMEDIATELY UPON MORCELLATION, AIR STARTED GOING THROUGH THE LINES, AND THE SYSTEM WOULD EVACUATE AND RESTART THROUGHOUT THE ENTIRE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, IT TOOK 20 MINUTES LONGER FOR THE DOCTOR TO COMPLETE THE PROCEDURE WHILE TROUBLE SHOOTING THE DEVICE. THERE ARE NO REPORTS OF INJURIES OR RISKS TO THE PATIENT OR OTHER PERSONNEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24888670 ↗MalfunctionApr 1, 2026Suction Failure
THE SURGEON NOTED THAT THE SUCTION PRESSURE ON THE PIRANHA SUCTION DEVICE WAS INSUFFICIENT DURING THE PROCEDURE AND STATED, "NOT ENOUGH VACUUM PRESSURE". THE INDEPENDENT SALES AGENT (ISA) CHECKED THE CONTROL CONSOLE AND THE PIRANHA DEVICE AND ADJUSTED THE PRESSURE SETTINGS ON ALL FOUR CONTROLS TO MATCH THOSE OF THE OTHER DEVICE THEY HAVE IN USE. NO FURTHER PROBLEMS WITH THE DEVICES HAVE BEEN REPORTED SINCE THEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757689 ↗InjuryOct 22, 2025Suction Failure; Suction Failure
ACCORDING TO THE INFORMATION RECEIVED, THE SUCTION PUMP FAILED TO PROVIDE SUFFICIENT SUCTION DURING A PROCEDURE. ALTHOUGH NO INJURIES WERE REPORTED, THE USER REPORTS THAT THE PLANNED TREATMENT COULD NOT BE COMPLETED AFTER A ONE-HOUR DELAY DUE TO TROUBLESHOOTING ATTEMPTS AND THAT NO BACK-UP DEVICE WAS AVAILABLE. THE FACILITY REPORTED THAT THEY ENDED UP HAVING TO CATH PATIENT WITH TISSUE LEFT BEHIND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23360331 ↗InjuryOct 22, 2025Suction Failure; Suction Failure
ACCORDING TO THE INFORMATION RECEIVED, THE SUCTION PUMP FAILED TO PROVIDE SUFFICIENT SUCTION DURING A PROCEDURE. ALTHOUGH NO INJURIES WERE REPORTED, THE USER REPORTS THAT THE PLANNED TREATMENT COULD NOT BE COMPLETED AFTER A ONE-HOUR DELAY DUE TO TROUBLESHOOTING ATTEMPTS AND THAT NO BACK-UP DEVICE WAS AVAILABLE. THE FACILITY REPORTED THAT THEY ENDED UP HAVING TO CATH PATIENT WITH TISSUE LEFT BEHIND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23360266 ↗InjurySep 9, 2025Suction Failure; Suction Failure
IT WAS REPORTED THAT DURING THE HOLEP SURGERY, FOUR (4) MORCELLATOR BLADES FAILED TO ROTATE AND THEREFORE, UNABLE TO PROVIDE SUCTION. THE FIRST BLADE WORKED FOR 10 MINUTES THEN LOCKED UP AND THE BLADES AFTER THAT LOCKED UP AS WELL UPON TESTING THEM BEFORE INSERTING THEM INTO THE PATIENT. THE USER TRIED TO REPLACED THE TUBING AND THE CONTAINER, HOWEVER, FAILED TO GET THE BLADES TO FUNCTION. DUE TO THE REPORTED ISSUE, THE SCHEDULED PROCEDURE WAS CANCELLED AS WELL AS THE SUCCEEDING CASES. THERE WERE NO REPORTS OF INJURIES TO THE PATIENT OR THIRD PARTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23006566 ↗InjurySep 9, 2025Suction Failure; Suction Failure
IT WAS REPORTED THAT DURING THE HOLEP SURGERY, FOUR (4) MORCELLATOR BLADES FAILED TO ROTATE AND THEREFORE, UNABLE TO PROVIDE SUCTION. THE FIRST BLADE WORKED FOR 10 MINUTES THEN LOCKED UP AND THE BLADES AFTER THAT LOCKED UP AS WELL UPON TESTING THEM BEFORE INSERTING THEM INTO THE PATIENT. THE USER TRIED TO REPLACE THE TUBING AND THE CONTAINER, HOWEVER, FAILED TO GET THE BLADES TO FUNCTION. DUE TO THE REPORTED ISSUE, THE SCHEDULED PROCEDURE WAS CANCELLED AS WELL AS THE SUCCEEDING CASES. THERE WERE NO REPORTS OF INJURIES TO THE PATIENT OR THIRD PARTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23006460 ↗MalfunctionAug 15, 2025Suction Problem; Suction Problem
ACCORDING TO THE INFORMATION RECEIVED, THE SUCTION PUMP FAILED TO PROVIDE SUFFICIENT SUCTION DURING THE PROCEDURE. THERE WAS NO REPORTED DELAY AND THE SCHEDULED PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816655 ↗InjuryMar 13, 2025Suction Failure; Suction Failure
ACCORDING TO THE INFORMATION RECEIVED, THE SUCTION PUMP, PART 2208011, SN# (B)(6), STOPPED WORKING DURING A HOLEP PROCEDURE. THE REPORTED PROBLEM CAUSED THE PROCEDURE TO BE CANCELLED AFTER A DELAY OF APPROX. 2 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21600566 ↗MalfunctionFeb 24, 2025Suction Problem; Suction Problem
ACCORDING TO THE INFORMATION RECEIVED, THE SUCTION PUMP FAILED TO PROVIDE SUFFICIENT SUCTION DURING THE MORCELLATION OF PROSTATE (HOLEP) PROCEDURE. THE USER REPORTED THAT THERE WAS A 30 MINUTE DELAY IN THE PROCEDURE. THERE WAS NO SIMILAR BACK-UP DEVICE, AND THE REMAINING TISSUES HAD TO BE BASKETED OUT. THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL MEDICAL TREATMENT. ALL THE OTHER DEVICES USED WITH THE SUCTION PUMP WERE WORKING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21452907 ↗InjuryFeb 20, 2025Suction Failure; Suction Failure
ACCORDING TO THE INFORMATION RECEIVED, THE MORCELLATOR SUCTION STOPPED WORKING DURING A HOLEP PROCEDURE. THE DISPOSABLE HANDPIECE WAS STILL ROTATING BUT WOULD NOT SUCK PROSTATE SPECIMEN INTO CANISTER. THERE WAS A REPORTED 30 MINUTES TO ONE HOUR DELAY TROUBLESHOOTING THE DEVICE. HOWEVER, THE SCHEDULED CASE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21426231 ↗InjuryFeb 20, 2025Suction Failure; Suction Failure
ACCORDING TO THE INFORMATION RECEIVED, THE MORCELLATOR SUCTION STOPPED WORKING DURING A HOLEP PROCEDURE. THE DISPOSABLE HANDPIECE WAS STILL ROTATING BUT WOULD NOT SUCK PROSTATE SPECIMEN INTO CANISTER. THERE WAS A REPORTED 30 MINUTES TO ONE HOUR DELAY TROUBLESHOOTING THE DEVICE. HOWEVER, THE SCHEDULED CASE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21426209 ↗MalfunctionJan 22, 2025Suction Failure; Suction Failure
ACCORDING TO THE INFORMATION RECEIVED, THE "UNIT STOPPED WORKING IN THE MIDDLE OF A CASE." THERE WAS A REPORTED DELAY OF 15 MINUTES AFTER THE PUMP WAS RESTARTED. HOWEVER, THE SCHEDULED CASE WAS COMPLETED WITHOUT ANY INJURY OR UNACCEPTABLE RISK TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21209263 ↗InjuryOct 30, 2024Mechanical Problem; Suction Problem; Mechanical Problem; Suction Problem
ACCORDING TO THE INFORMATION RECEIVED, A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) AND TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE WAS SCHEDULED. IT WAS REPORTED THAT DURING MORCELLATION, THE SUCTION FAILED ON ONE OF THE HANDPIECES. THE HANDPIECE WAS REPLACED, AND THE SUCTION IS WORKING. HOWEVER, WITH THE SECOND HANDPIECE, THE MORCELLATOR BLADE NO LONGER TURNED. THE BLADE WAS REPLACED 4 TIMES, WITHOUT SUCCESS. ALL ATTEMPTS TO TROUBLESHOOT, EVEN WITH GUIDANCE FROM A SERVICE TECHNICIAN, WERE UNSUCCESSFUL. DUE TO IT, THE SCHEDULED OPERATION WAS ABORTED. THE PATIENT MUST BE READMITTED WHEN THE DEVICE IS READY FOR USE AGAIN.
Patient problems: Insufficient Information
MAUDE report 20566608 ↗
Other Richard Wolf GmbH products
All Richard Wolf GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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