PIRANHA 2208011Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 04055207011874), received between Oct 4, 2018 and Sep 22, 2026 — classified as 19 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (29 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 54 reports, 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 ↗
• 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 ↗
• MalfunctionOct 1, 2024Decrease in Suction; Decrease in Suction

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL#: (B)(6). ACCORDING TO THE RECEIVED INFORMATION, THE SUCTION PUMP FAILED TO PROVIDE SUFFICIENT SUCTION. THE REDUCTION IN SUCTION HAS BEEN NOTICED BY A HEALTH PROFESSIONAL ON PROCEDURES WITH LARGER PROSTATES (OVER 150 GRAMS) AFTER THE INITIAL CANISTER CHANGE DURING MORCELLATION, WITH BOTH THE TISSUE TRAP AND BACTERIA FILTER ARE CHANGED EACH TIME A CANISTER CHANGE TAKES PLACE. THE ISSUE HAS BEEN NOTED OVER THE LAST FEW MONTHS OF PROCEDURE. IN ADDITION, THE HEALTHCARE PROFESSIONAL NOTED THERE IS NO REDUCTION IN SUCTION ON PROCEDURES WITH SMALLER PROSTATES AND NO CANISTER CHANGES.

  Patient problems: Insufficient Information

  MAUDE report 20348473 ↗
• MalfunctionJul 16, 2024Suction Failure; Suction Failure

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL # (B)(6). ACCORDING TO THE INITIAL REPORTER, THE MORCELLATOR MALFUNCTIONED DURING A PROCEDURE AND NO LONGER PROVIDED SUCTION. THERE WAS NO REPORTED DELAY IN THE PROCEDURE AND NO ADDITIONAL TREATMENT REQUIRED. A SIMILAR BACK-UP DEVICE WAS AVAILABLE AND THE SCHEDULED PROCEDURE WAS COMPLETED. THERE IS NO REPORT OF INJURY TO THE PATIENT AS WELL AS, ANY OTHER PERSONNEL. HOWEVER, RWMIC OPTED TO SUBMIT A REPORT IN ACCORDANCE WITH THE FDA GUIDANCE DOCUMENT MEDICAL DEVICE REPORTING FOR MANUFACTURERS, WHICH REQUIRES AN MDR AS PREVIOUS COMPLAINTS INVOLVING DEVICE, 2208011, WITH SIMILAR ISSUE WERE REPORTED AS A SERIOUS INJURY. THIS MATTER WAS CONSIDERED AS A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755218 ↗
• MalfunctionMay 2, 2024Decrease in Suction; Decrease in Suction

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL # (B)(6). ACCORDING TO THE INITIAL REPORTER, DURING A PREVENTIVE MAINTENANCE CHECK, THE SUCTION PUMP HAS A LOW SUCTION. THE REPORTED ISSUE HAS NO PATIENT INVOLVEMENT AND DID NOT OCCURRED DURING A PROCEDURE. THERE IS NO REPORT OF INJURY TO ANY OTHER PERSONNEL. HOWEVER, RWMIC OPTED TO SUBMIT A REPORT IN ACCORDANCE WITH THE FDA GUIDANCE DOCUMENT MEDICAL DEVICE REPORTING FOR MANUFACTURERS, WHICH REQUIRES AN MDR AS PREVIOUS MDRS WITH SIMILAR ISSUE WERE REPORTED AS A SERIOUS INJURY. THIS MATTER WAS CONSIDERED AS A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234555 ↗
• InjuryFeb 29, 2024Suction Failure; Suction Failure

  A MEDICAL SUPPLIER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL # (B)(6). ACCORDING TO THE INITIAL REPORTER, DURING A CASE THE SUCTION WORKS FOR A COUPLE OF SECONDS AND THEN IT STOPS. AS THE SUCTION WORKS INTERMITTENTLY, THE SCHEDULED PROCEDURE WAS UNABLE TO BE COMPLETED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: Insufficient Information

  MAUDE report 18809375 ↗
• InjuryFeb 29, 2024Suction Failure; Suction Failure

  A MEDICAL SUPPLIER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL # (B)(6). ACCORDING TO THE INITIAL REPORTER, DURING A CASE THE SUCTION WORKS FOR A COUPLE OF SECONDS AND THEN IT STOPS. AS THE SUCTION WORKS INTERMITTENTLY, THE SCHEDULED PROCEDURE WAS UNABLE TO BE COMPLETED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: Insufficient Information

  MAUDE report 18809195 ↗
• InjuryFeb 20, 2024Failure to Cut; Suction Failure; Poor Visibility; Failure to Cut; Suction Failure; Poor Visibility

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE, AT THE START OF MORCELLATION DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, THE BLADES WERE NOT BITING ANY OF THE TISSUE NOR SUCKING THE TISSUE TOWARD THE BLADES. DURING THIS TIME, VISUALIZATION WAS POOR AND LOST DISTENSION A COUPLE OF TIMES AND UNFORTUNATELY NICKED THE BLADDER TWICE. THE SURGEON ABORTED THE PROCEDURE AND CHANGE TO A STANDARD TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE TO COMPLETE THE CASE. AN ADDITIONAL PROCEDURE WAS NEEDED TO REPAIR THE PATIENT'S BLADDER. LATER, THE INITIAL REPORTER CLARIFIED THAT THE SUCTION TO THE CANISTERS WAS WORKING FINE. THE BLADES WOULD NOT HOLD OR BITE THE TISSUE. THE OPERATION TIME WAS PROLONGED BY 90 MINUTES DUE TO THE SURGICAL STAFF TRYING TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18743728 ↗
• InjuryOct 27, 2023Suction Failure; Suction Failure

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL # (B)(6). ACCORDING TO THE USER FACILITY, "SUCTION WAS GOOD AT THE BEGINNING OF THE PROCEDURE, BUT DIMINISHED THROUGH THE MORCELLATION PART OF THE PROCEDURE UNTIL IT WOULD NOT HOLD TISSUE AT THE TIP OF THE PIRANHA BLADE. THE SURGICAL PROCEDURE COULD NOT BE COMPLETED." THE REPORTED ISSUE CAUSED A 10 MINUTE DELAY DURING A HOLEP PROCEDURE WHILE THEY TRIED TO RESOLVE THE REPORTED ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18024842 ↗
• InjuryOct 27, 2023Suction Failure; Suction Failure

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL#: (B)(6). ACCORDING TO THE USER FACILITY, "SUCTION WAS GOOD AT THE BEGINNING OF THE PROCEDURE, BUT DIMINISHED THROUGH THE MORCELLATION PART OF THE PROCEDURE UNTIL IT WOULD NOT HOLD TISSUE AT THE TIP OF THE PIRANHA BLADE. THE SURGICAL PROCEDURE COULD NOT BE COMPLETED." THE REPORTED ISSUE CAUSED A 10 MINUTE DELAY DURING A HOLEP PROCEDURE WHILE THEY TRIED TO RESOLVE THE REPORTED ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18023985 ↗
• MalfunctionOct 5, 2023Suction Failure; Suction Failure

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL # (B)(6). ACCORDING TO THE USER FACILITY, "THE SALES REP AND CUSTOMER PREPARED THEIR EQUIPMENT BEFORE THE PROCEDURE. BEFORE THE PATIENT WAS BROUGHT IN THEY DID A SUCTION CHECK AND THE SUCTION WASN'T WORKING. THEY TRIED TO REPLACE THE FOOT PEDAL, SILENCER, AND TUBING. WHEN THEY SWITCHED OUT THE SUCTION PUMP UNIT, EVERYTHING STARTED TO WORK. THEN THE PATIENT WAS BROUGHT INTO THE ROOM AND THE CASE BEGAN." IN ADDITION, THE DEVICE WAS NOT BEING USED ON A PATIENT WHEN THE REPORTED ISSUE WAS IDENTIFIED PRIOR TO A HOLE PROCEDURE. A BACK-UP DEVICE WAS RETRIEVED TO PROCEED WITH THE SCHEDULED PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL AND NO TIME DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881369 ↗
• InjuryAug 31, 2023Suction Failure; Suction Failure

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL # (B)(6). ACCORDING TO THE USER FACILITY, " THE MORCELLATION PUMP WASN'T ABLE TO BUILD ENOUGH SUCTION TO ALLOW MORCELLATION. IN ADDITION, THE REPORTED ISSUE CAUSED A DELAY IN THE MIDDLE OF MORCELLATING THE PROSTATE DURING THE HOLEP PROCEDURE. THE PATIENT HAD TO BE CATHETERIZED OVER THE WEEKEND. THERE WAS NO BACK-UP DEVICE AVAILABLE AND THE SCHEDULED PROCEDURE WAS NOT COMPLETED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664730 ↗
• InjuryAug 31, 2023Suction Failure; Suction Failure

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL # (B)(6). ACCORDING TO THE USER FACILITY, "THE MORCELLATION PUMP WASN'T ABLE TO BUILD ENOUGH SUCTION TO ALLOW MORCELLATION." IN ADDITION, THE REPORTED ISSUE CAUSED A DELAY IN THE MIDDLE OF MORCELLATING THE PROSTATE DURING THE HOLEP PROCEDURE. THE PATIENT HAD TO BE CATHETERIZED OVER THE WEEKEND. THERE WAS NO BACK-UP DEVICE AVAILABLE AND THE SCHEDULED PROCEDURE WAS NOT COMPLETED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664695 ↗
• InjuryAug 2, 2023Suction Failure; Suction Failure

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL # (B)(6). ACCORDING TO THE USER FACILITY, "THE UNIT WOULD NOT CREATE SUCTION." AFTER TRYING TO TROUBLESHOOT THE PUMP ISSUE, THE DOCTOR CALLED OFF THE SURGERY. IN ADDITION, THE REPORTED ISSUE CAUSED A 10 MINUTE DELAY DURING THE HOLEP PROCEDURE WHILE THEY TRIED TO RESOLVED THE REPORTED ISSUE. THERE WAS NO BACK-UP DEVICE AVAILABLE AND THE SCHEDULED PROCEDURE WAS NOT COMPLETED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: Insufficient Information

  MAUDE report 17445861 ↗
• InjuryAug 2, 2023Suction Failure; Suction Failure

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A SUCTION PUMP, PART ID: 2208011, SERIAL # (B)(6). ACCORDING TO THE USER FACILITY, "THE UNIT WOULD NOT CREATE SUCTION." AFTER TRYING TO TROUBLESHOOT THE PUMP ISSUE, THE DOCTOR CALLED OFF THE SURGERY. IN ADDITION, THE REPORTED ISSUE CAUSED A 10 MINUTE DELAY DURING THE HOLEP PROCEDURE WHILE THEY TRIED TO RESOLVED THE REPORTED ISSUE. THERE WAS NO BACK-UP DEVICE AVAILABLE AND THE SCHEDULED PROCEDURE WAS NOT COMPLETED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: Insufficient Information

  MAUDE report 17445783 ↗