Conceal 720182-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00878953005676), received between Dec 11, 2018 and May 26, 2026 — classified as 53 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 16, 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.

• InjuryMay 26, 2026Migration

  IT WAS REPORTED THAT THE RESERVOIR OF AN INFLATABLE PENILE PROSTHESIS (IPP) HAD MIGRATED FROM THE ANTERIOR BLADDER SPACE TO THE GROIN. A SURGICAL PROCEDURE WAS PERFORMED TO REPOSITION THE RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285396 ↗
• InjuryMay 22, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED TO THE HOSPITAL WITH A NON-FUNCTIONAL DEVICE. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED AND UPON INSPECTION, THERE WAS A CRACK FOUND IN THE RESERVOIR CONNECTING TUBE. AS A RESULT, THE PHYSICIAN REMOVED AND REPLACED THE RESERVOIR AND PUMP. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256570 ↗
• InjuryMar 24, 2026Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A HOLE IN THE RESERVOIR WAS FOUND. THE RESERVOIR AND CYLINDERS WERE REMOVED AND REPLACED, THE RESERVOIR THAT WAS KEPT IN THE PATIENT WAS NOT REMOVED AND A NEW ONE WAS ADDED TO THE SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673680 ↗
• InjuryNov 12, 2025Deflation Problem; Fluid/Blood Leak; Inflation Problem; Deflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISCOMFORT AND A SPONTANEOUS INCREASE IN VOLUME ON THE RIGHT PENOSCROTAL SIDE, WITHOUT ANY IDENTIFIABLE CAUSE. THE PATIENT CONSULTED A UROLOGIST, WHO PRESCRIBED ANTIBIOTICS AND ANTI-INFLAMMATORY MEDICATION. LATER, THE PATIENT ATTEMPTED TO ACTIVATE THE PROSTHESIS BUT WAS UNSUCCESSFUL. UPON FOLLOW-UP, THE PHYSICIAN CONFIRMED THAT THE DEVICE COULD NEITHER BE INFLATED NOR DEFLATED. MAGNETIC RESONANCE IMAGING (MRI) REVEALED NO FLUID IN THE RESERVOIR DUE A LEAK FROM SOME CONNECTION. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 23538510 ↗
• InjuryOct 17, 2025Fluid/Blood Leak; Nonstandard Device; Connection Problem; Fluid/Blood Leak; Nonstandard Device; Connection Problem

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS LEAKING, AND THE DEVICE COULD NOT BE USED NORMALLY FOR ERECTION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE RESERVOIR. THE CAUSE OF THE FLUID LOSS WAS A CONNECTION ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323364 ↗
• InjuryJun 25, 2025Fluid/Blood Leak; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING. THE PHYSICIAN CONFIRMED, THROUGH ULTRASOUND AND OTHER EXAMINATIONS, THAT THERE WAS NO FLUID IN THE RESERVOIR. THE IPP WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333126 ↗
• InjuryJun 18, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY, AND THE ULTRASOUND SHOWED THE RESERVOIR EMPTY. THE CAUSE OF THE ISSUE WAS UNKNOWN. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH A NEW RESERVOIR WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286939 ↗
• InjuryApr 9, 2025Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED 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 21810625 ↗
• InjuryMar 26, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED IN MAY 2024, THEN, IN JULY, IT WAS FOUND THAT THE PUMP WAS DIFFICULT TO PRESS. AFTER THIS, IN DECEMBER, IT WAS FOUND THAT THE PUMP DID NOT REBOUND AFTER PRESSING, AND LATER TESTS DID NOT REBOUND. FINALLY, DURING A SURGICAL PROCEDURE IN 2025, IT WAS DETERMINED THE DEVICE CONNECTION WAS INTACT AND THERE WAS WATER IN THE BALLON, BUT THE PUMP DID NOT REBOUND AT ALL, SO IT WAS REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701547 ↗
• InjuryJan 22, 2025Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) DID NOT WORK PROPERLY. AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THE RESERVOIR HAD A HOLE. THE PUMP AND RESERVOIR WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209676 ↗
• InjuryDec 3, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A HOLE IN THE RESERVOIR WAS FOUND. THE PUMP WAS REMOVED AND REPLACED, WHILE THE EXISTING RESERVOIR WAS KEPT IN THE PATIENT AND A NEW ONE WAS ADDED TO THE SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831867 ↗
• InjuryNov 21, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A HOLE IN THE RESERVOIR WAS NOTED. ALL COMPONENTS WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747280 ↗
• InjuryOct 1, 2024Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole; Fluid/Blood Leak; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) COULD NOT BE TURNED ON TO USE THE DEVICE. IT WAS NOTED THERE WAS LESS LIQUID IN THE RESERVOIR. UPON REMOVAL, THE RESERVOIR WAS FOUND TO BE DAMAGED AND NEEDED REPLACEMENT. THE IPP WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344170 ↗
• InjuryJul 16, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A HOLE IN THE RESERVOIR WAS FOUND. THE PUMP WAS REMOVED AND REPLACED, WHILE THE EXISTING RESERVOIR WAS KEPT IN THE PATIENT AND A NEW ONE WAS ADDED TO THE SYSTEM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757627 ↗
• InjuryJun 18, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A REVISION SURGERY WAS PERFORMED, DURING WHICH A HOLE IN THE RESERVOIR WAS IDENTIFIED. THE PUMP WAS REMOVED AND REPLACED, WHILE THE OLD RESERVOIR WAS KEPT IN THE PATIENT AND A NEW ONE WAS ADDED TO THE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558049 ↗
• InjuryApr 3, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS EXPECTED. TWO WEEKS LATER A REVISION SURGERY WAS PERFORMED, UPON EXAMINATION A HOLE IN THE RESERVOIR WAS FOUND. THEREFORE, IT WAS DECIDED TO REPLACE THE RESERVOIR AND PUMP, LEAVING THE PREVIOUS RESERVOIR IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033726 ↗
• InjuryMar 29, 2024Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A REVISION SURGERY WAS PERFORMED, DURING WHICH IT WAS NOTED THAT THE RESERVOIR HAD A HOLE. THE RESERVOIR AND THE PUMP WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008673 ↗
• InjuryMar 5, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS WAS DISSATISFIED WITH THE RESERVOIR PLACEMENT AS IT WAS HERNIATING AND COULD BE SEEN. THE PHYSICIAN REMOVED THE RESERVOIR ONLY AND PLACED THE NEW RESERVOIR DEEPER IN THE BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841436 ↗
• InjuryJan 22, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED TO THE HOSPITAL BECAUSE THE DEVICE WAS NOT FUNCTIONING PROPERLY. TWO WEEKS LATER, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REVISE THE IPP AND A CRACK IN THE RESERVOIR CONNECTING TUBE WAS FOUND. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18560194 ↗
• InjuryDec 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED FLUID LOSS FROM THE RESERVOIR. ALL COMPONENTS OF THE EXISTING IPP WERE EXPLANTED AND REPLACED WITH A NEW MALLEABLE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334416 ↗
• InjuryDec 4, 2023Malposition of Device; Malposition of Device

  (REFER TO MANUFACTURERS REPORT REF# (B)(4)) IT WAS REPORTED THAT, FOLLOWING REPLACEMENT AND REPOSITIONING OF THE INFLATABLE PENILE PROSTHESIS RESERVOIR ECTOPICALLY IN THE ILIAC REGION, THE PATIENT WAS MORE COMFORTABLE STANDING AND THE LEG AND GAIT ISSUES EXPERIENCED FOLLOWING THE PREVIOUS IMPLANT RESOLVED. HOWEVER, IT WAS NOTED THAT BALANCE DID NOT FULLY RETURN. WHEN WALKING AND SITTING, IT FELT THAT THE RESERVOIR WAS INTERFERING WITH THE BODY RIGIDITY, AS IF PUSHING IT BACK. UPON DEVICE ACTIVATION, THE RIGIDITY SUBSIDED AND TENSION IN THE PERINEUM INCREASED. THE NEW POSITION OF THE RESERVOIR WAS MORE COMFORTABLE BUT PERSISTENT SYMPTOMS, INCLUDING NIGHT SWEATS, WEAKNESS, APATHY, AND BRAIN FOG REMAINED, IMPACTING QUALITY OF LIFE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. FURTHER INFORMATION RECEIVED INDICATED THE PATIENT EXPERIENCED SIGNS OF ONGOING MODERATE AUTOIMMUNE SYMPTOMS AS WELL AS TACHYCARDIA, WEAKNESS, LETHARGY, HYPERTONICITY IN THE LEG, LOWER BACK PAIN, AND SCOLIOSIS. A NEUROLOGIST TREATED THE PATIENT FOR PAIN WITHOUT ANY EFFECT. THERE WERE POLYMORPHIC NEUROLOGICAL SYMPTOMS ASSOCIATED WITH THE RESERVOIR IN THE RETZIUS SPACE. THE PATIENT SYMPTOMS WERE PRESUMED BY THE

  Patient problems: Balance Problems; Diaphoresis; Discomfort; Insufficient Information; Muscle Weakness/Atrophy; Neuropathy; Pain; Tachycardia; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 18259715 ↗
• InjurySep 12, 2023Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT VISITED THE HOSPITAL BECAUSE HIS INFLATABLE PENILE PROSTHESIS WAS NOT PERFORMING AS EXPECTED. THE PATIENT UNDERWENT SURGERY TWO WEEKS LATER AND INSPECTION REVEALED A HOLE IN THE RIGHT CYLINDER CONNECTING TUBE. THE PUMP AND CYLINDER WERE REMOVED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733134 ↗
• InjuryAug 8, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AS THE INFLATABLE PENILE PROSTHESIS DID NOT WORK AS EXPECTED. TWO WEEKS LATER, THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS RESERVOIR AND PUMP REPLACED DUE TO A HOLE IN THE RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484825 ↗
• InjuryMay 10, 2023Mechanical Problem; Material Puncture/Hole; Mechanical Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL BECAUSE THE INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A REVISION SURGERY WAS PERFORMED IN WHICH IT WAS CONFIRMED THAT THE RESERVOIR HAD A HOLE. THE PUMP WAS REMOVED AND REPLACED, AND A NEW RESERVOIR WAS PLACED. THE OLD RESERVOIR WAS LEFT INSIDE THE PATIENT. THE CAUSE OF THE RESERVOIR HOLE WAS NOT DETAILED BY THE HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901965 ↗
• InjuryDec 13, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPLACE AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO A HOLE IN THE RESERVOIR THAT RESULTED IN THE DEVICE NOT WORKING. A NEW IPP RESERVOIR WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971576 ↗