MS Pump 72404209Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00878953003351), received between Nov 9, 2018 and Jun 10, 2026 — classified as 68 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WOULD NOT INFLATE AND EXHIBITED FLUID LOSS. UPON REMOVAL, SEVERE STRUCTURAL DAMAGE TO THE TUBING WAS OBSERVED, INCLUDING EXPOSURE OF SUTURE WIRE AND TUBING THAT WAS FUSED TOGETHER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25463929 ↗
• InjuryApr 24, 2026Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED A MECHANICAL PROBLEM. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987594 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED A LOCALIZED SCROTAL INFECTION INVOLVING THE PUMP SITE. THE PATIENT HAD PREVIOUSLY UNDERGONE A REVISION PROCEDURE TO EXCHANGE THE TENACIO PUMP WITH AN MS PUMP. DURING THE POSTOPERATIVE RECOVERY PERIOD, THE PATIENT REPORTED CYCLING THE PUMP AND RETURNING TO THE GYM FOR EXERCISE. THE PATIENT SUBSEQUENTLY EXPERIENCED SCROTAL SWELLING AND PRESENTED TO THE EMERGENCY DEPARTMENT, WHERE IMAGING IDENTIFIED A RIM ENHANCING FLUID COLLECTION SURROUNDING THE SCROTAL PUMP, CONSISTENT WITH A LOCALIZED INFECTION. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE PUMP WAS EXPLANTED, METAL TUBING PLUGS WERE PLACED TO RETAIN THE REMAINING COMPONENTS, AND THE SCROTUM WAS THOROUGHLY IRRIGATED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Fluid Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 24134248 ↗
• InjuryDec 8, 2025Collapse; Inflation Problem; Mechanical Problem; Use of Device Problem; Air/Gas in Device; Collapse; Inflation Problem; Mechanical Problem; Use of Device Problem; Air/Gas in Device

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A NONFUNCTIONING DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN NOTED THAT THE PUMP WAS COMPLETELY COMPRESSED AND WOULD NOT RECOIL. THE PHYSICIAN SUSPECTED A SIGNIFICANT ACCUMULATION OF AIR WITHIN THE SYSTEM, AND IT WAS NOTED THAT THERE WAS A POSSIBILITY THE RESERVOIR HAD NOT BEEN PROPERLY PREPPED. THE PHYSICIAN NOTED THE IPP WAS SCARRED SIGNIFICANTLY IN THE SCROTAL AREA REQUIRING LYSIS OF ADHESIONS TO GAIN ACCESS TO THE BILATERAL CORPORA CAVERNOSUM. THE CYLINDERS AND PUMP WERE EXPLANTED INTACT. HOWEVER, AFTER REMOVING THE RESERVOIR, UNCONTROLLED BLEEDING OCCURRED FROM THE POSTERIOR TO THE RECTUS MUSCLE. VASCULAR SURGERY WAS CONSULTED TO HELP CONTROL THE BLEEDING. THE ILIAC VESSELS DEEP AND LATERAL TO THE AREA THAT WAS BLEEDING WERE LIGATED WITH A 4.0 PROLENE STITCH. ONCE THE BLEEDING WAS CONTROLLED AND PATIENT RESUSCITATED, A TACTRA MALLEABLE IMPLANT WAS PLACED. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT WHERE HE RECEIVED TRANSFUSION OF RED BLOOD CELLS, FRESH FROZEN PLASMA, ALBUMIN AND IV FLUIDS. AFTER PERFORMING A CT, A HEMATOMA WAS OBSERVED IN THE RIGHT

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Scar Tissue

  MAUDE report 23751630 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AN INFECTION, PRESENTING WITH PURULENT DRAINAGE FROM THE SCROTAL INCISION. THE PATIENT WAS HOSPITALIZED AND PLACED ON ANTIBIOTICS. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE CYLINDERS, REAR TIP EXTENDERS, AND PUMP WERE REMOVED. UPON REMOVAL OF THE RESERVOIR, BLEEDING WAS NOTED, AND THE RESERVOIR WAS DRAINED AND RETAINED. THE CORPORAL BODIES AND THE SCROTAL INCISION WERE CLOSED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 23073816 ↗
• InjuryAug 28, 2025Fluid/Blood Leak; Inflation Problem; Nonstandard Device; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Nonstandard Device; Material Puncture/Hole

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING, CAUSING THE DEVICE TO STOPPED WORKING. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A FLUID LOSS AND A HOLE WAS IDENTIFIED IN THE RIGHT CYLINDER. THEREFORE, THE IPP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911444 ↗
• InjuryJul 16, 2025Inflation Problem; Malposition of Device; Inflation Problem; Malposition of Device

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS IPP PRESENTED WITH A HIGH RIDING PUMP. A REPLACEMENT SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE PUMP WAS NOT IDEALLY POSITIONED AND THAT THE PATIENT MAY HAVE HAD TROUBLE PUMPING TO INFLATE THE PUMP DUE TO ITS POSITION. THE PUMP WAS EXPLANTED AND REPLACED WITH A NEW ONE IN A MORE DEPENDENT POSITION WITHIN THE SCROTUM. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520754 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS PRESENTED WITH PAIN IN SCROTUM. A REPLACEMENT SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN REPLACED PUMP. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 22390928 ↗
• InjuryJul 1, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DISSATISFIED WITH THE DEVICE, AS THE PUMP STOPPED WORKING. THE PHYSICIAN WAS UNSURE WHETHER THE ISSUE WAS DUE TO A LEAK OR GENERAL WEAR AND TEAR. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE ENTIRE DEVICE WAS REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22376517 ↗
• InjuryMay 13, 2025Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING DUE TO THE CYLINDERS BROKE AND CAUSE A FLUID LOSS. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014280 ↗
• InjuryJan 2, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THERE WAS A CRACK IN THE LEFT CYLINDER CONNECTING TUBE. THE PUMP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21058496 ↗
• InjuryDec 13, 2024Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING. THE PUMP WAS REMOVED, AND IT FUNCTIONED FINE OUTSIDE THE BODY. THE PHYSICIAN SUSPECTED KINKED TUBING OR TISSUE HEALED OVER PUMP WHICH DID NOT ALLOW FLUID TO PASS. THE PUMP WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922090 ↗
• InjuryDec 11, 2024Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Fluid/Blood Leak; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING. THE DEVICE WOULD NOT INFLATE DUE FLUID LOSS AND THE RESERVOIR WAS EMPTY. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20908868 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH INFECTION, A SMALL HOLE IN THE SCROTUM, URETHRAL SENSITIVITY AND DISCOMFORT. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH IT WAS NOTED THAT THE RIGHT CYLINDER HAD PERFORATED OUT OF THE CORPORA INTO THE URETHRA; THEREFORE, THE EXISTING IPP WAS REMOVED, A CATHETER WAS PLACED, AND NO NEW COMPONENTS WERE IMPLANTED. THERE WERE NO DEVICE ISSUES AND NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort; Perforation; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 20905730 ↗
• InjurySep 26, 2024Collapse; Inflation Problem; Defective Device; Air/Gas in Device; Collapse; Inflation Problem; Defective Device; Air/Gas in Device

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT ABLE TO BE PUMPED UP. IT WAS NOTED THAT THERE WAS AIR IN THE SYSTEM AND THAT THE PUMP STAYS FLAT. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310141 ↗
• InjurySep 21, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REMOVE AND REPLACE AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO EROSION OF THE CYLINDER. THE PATIENT WAS EXPERIENCING DISCOMFORT WITH THE CYLINDER. THE PATIENT IS EXPECTED TO FULLY RECOVER FOLLOWING THE PROCEDURE.

  Patient problems: Discomfort; Erosion

  MAUDE report 20275487 ↗
• MalfunctionAug 28, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE PATIENT THAT THE FLUID IN THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS UNABLE TO BE TRANSFERRED TO THE CYLINDERS AS THE PUMP BULB OF THIS IPP DOES NOT REFILL AFTER DEPRESSED. THE PATIENT FURTHER STATED HE HAS ATTEMPTED TROUBLESHOOTING TECHNIQUES WITH NO RESOLUTION. THE PATIENT HAS AN APPOINTMENT WITH PHYSICIAN FOR EVALUATION AND NEXT STEPS. NO PATIENT COMPLICATIONS WERE REPORTED, AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087352 ↗
• InjuryAug 9, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) STOPPED WORKING DUE TO FLUID LOSS. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE ALL THE COMPONENTS AND IMPLANT A MALLEABLE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950597 ↗
• InjuryJun 20, 2024Fluid/Blood Leak; Defective Device; Fluid/Blood Leak; Defective Device

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING AS INTENDED DUE TO CYLINDER BREAKDOWN BILATERALLY AND FLUID LOSS. THE PATIENT WAS UNABLE TO USE THE DEVICE. THE IPP WAS REPLACED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576746 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS HAD A PAINFUL ENLARGED SCROTUM,. THE DEVICE WAS EXPLANTED, AND THE AREA WAS IRRIGATED WITH ANTIBIOTICS. A TACTRA MALLEABLE PENILE PROSTHESIS WAS PLACED ALONG WITH A DRAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19359967 ↗
• InjuryMay 14, 2024Collapse; Adverse Event Without Identified Device or Use Problem; Collapse; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED DUE TO IT COLLAPSED AND WAS UNABLE TO REFILL. THE PUMP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19314938 ↗
• InjuryApr 4, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION DUE TO THE MIGRATION OF THE LEFT CYLINDER INTO THE URETHRA. A REVISION SURGERY WAS PERFORMED TO REMOVE THE LEFT CYLINDER, PLUGGED THE TUBING, AND PLACED A MALLEABLE DEVICE ON THE LEFT CORPORA. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 19048025 ↗
• InjuryFeb 1, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING FOLLOW APPOINTMENT, IT WAS NOTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) PUMP IS NOT WORKING PROPERLY, AS THE DEVICE IS NOT HAVING ENOUGH FIRMNESS IN THE CYLINDERS AND BEING POINTS DOWN WHEN FULLY PUMPED. IT WAS STATED THAT THIS IS CAUSING PAIN IN THE GLANS ON THE RIGHT SIDE, AS WELL AS AN UNSPECIFIED INJURY TO THE PATIENT'S WIFE. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT HAD SMALL SKIN DEHISCENCE BUT IS DRY, WITH NO SIGNS OF DRAINAGE OR INFECTION. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 18624881 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW MONTHS AGO THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A DISTAL EROSION; THEREFORE, THE DEVICE WAS EXPLANTED. NOW THAT THE DISTAL EROSION HAS HEALED, A NEW SURGERY HAS BEEN PERFORMED TO IMPLANT A MALLEABLE DEVICE. NO DEVICE ISSUES NOR ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 18178499 ↗
• InjuryNov 20, 2023Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY DUE TO FLUID LEAKAGE AT AN UNKNOWN LOCATION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18176435 ↗