Conceal 720185-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 586 adverse event reports that list this exact device (DI 00878953005669), received between Aug 9, 2018 and Sep 30, 2026 — classified as 549 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Migration” (296 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 586 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient implanted with this Inflatable Penile Prosthesis (IPP) developed an infection. In (b)(6) 2024, a surgical procedure was performed to explant the IPP; however, the reservoir was left implanted. Subsequently, on (b)(6) 2026, a revision procedure was performed during which the retained reservoir was removed, and all new device components were implanted. No additional patient complications were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50950318 ↗
• InjurySep 24, 2026Use of Device Problem; Migration

  It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced abdominal pain and herniation of the reservoir. The physician indicated that the patient may not have followed postoperative restrictions and may have lifted a heavy object, which was believed to have contributed to the reservoir herniation. A surgical procedure was performed during which the reservoir was explanted and replaced. No further patient complications were reported.

  Patient problems: Pain

  MAUDE report 50883231 ↗
• InjurySep 8, 2026Malposition of Device

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) reservoir was malpositioned. The reservoir was surgically repositioned. No device components were explanted, and no patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668300 ↗
• InjurySep 4, 2026Migration

  It was reported that this Inflatable Penile Prosthesis (IPP) presented migration. A surgical procedure was performed during which the existing reservoir was explanted and replaced with a new one. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615751 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this patient with an Inflatable Penile Prosthesis (IPP) experienced an infection. A surgical procedure was performed during which the device was explanted. No additional information was provided.

  Patient problems: Unspecified Infection

  MAUDE report 50602286 ↗
• InjurySep 1, 2026Fluid/Blood Leak; Inflation Problem; Mechanical Problem; Material Puncture/Hole

  It was reported that an Inflatable Penile Prosthesis (IPP) was not fully inflating, resulting in a sticky pump. Upon revision, it was found that the tubing at the reservoir head was broken and partially detached, which was suspected to be the cause of the device's inability to fully inflate and fluid loss. As a result, the device was removed and replaced. The Tenacio pump was replaced with an MS pump because the patient found it difficult to operate. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50553498 ↗
• InjuryAug 31, 2026Mechanical Problem

  It was reported that an Inflatable Penile Prosthesis (IPP) stopped functioning. A surgical procedure was performed to remove and replace the reservoir. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515493 ↗
• InjuryAug 20, 2026Inflation Problem

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) exhibited auto inflation. A surgical procedure was performed, during which a capsular formation surrounding the reservoir was identified. The reservoir was laparoscopically released from the capsule, which resolved the auto inflation issue. Additionally, the patient requested replacement of the existing MS pump with a Tenacio pump. As a result, the pump was exchanged for a Tenacio pump during the same procedure. No additional patient complications were reported.

  Patient problems: Capsular Contracture

  MAUDE report 50360027 ↗
• InjuryAug 20, 2026Migration

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) experienced pain due to migration of the reservoir through inguinal ring. A surgical procedure was performed during which the existing device was explanted and replaced with a new IPP. There were no further patient complications reported.

  Patient problems: Pain

  MAUDE report 50349162 ↗
• InjuryAug 19, 2026Fluid/Blood Leak

  It was reported that the patient's Inflatable Penile Prosthesis (IPP) exhibited a fluid loss. A surgical procedure was performed to fully replaced the IPP. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326181 ↗
• InjuryJul 20, 2026Migration

  It was reported that a patient with an Inflatable Penile Prosthesis (IPP) experienced right inguinal pain. The reservoir was found to have migrated to the right inguinal region. A surgical procedure was performed to remove and replace the reservoir. No further patient complications were reported.

  Patient problems: Pain

  MAUDE report 25883954 ↗
• MalfunctionJul 20, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883615 ↗
• InjuryJul 14, 2026Migration

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR HERNIATED TO THE GROIN. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE RESERVOIR WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25815595 ↗
• InjuryJun 25, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PAIN. THE RESERVOIR MIGRATED TO THE ABDOMINAL AREA. AS A RESULT, THE RESERVOIR WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25631194 ↗
• InjuryJun 12, 2026Migration

  IT WAS REPORTED THAT THE RESERVOIR OF AN INFLATABLE PENILE PROSTHESIS (IPP) HAD MIGRATED FROM THE RIGHT RETROPUBIC SPACE ADJACENT TO THE BLADDER TO OUTSIDE THE INGUINAL RING DURING INTERCOURSE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488690 ↗
• InjuryJun 2, 2026Migration

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) RESERVOIR HERNIATED. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED SUB MUSCULARLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363084 ↗
• InjuryMay 29, 2026Migration

  IT WAS REPORTED THAT THE RESERVOIR OF THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD MIGRATED OUT OF THE SPACE OF RETZIUS TO THE SCROTAL AREA. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334399 ↗
• InjuryMay 22, 2026Inflation Problem; Nonstandard Device; Material Deformation

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS DIFFICULT TO INFLATE AND DEFLATE. THE PHYSICIAN SUSPECTED IT WAS DUE TO FLUID LOSS AT THE RESERVOIR AND THEN PERFORMED A SURGICAL PROCEDURE DURING WHICH THE RESERVOIR WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN EXAMINED THE RESERVOIR, AND IT APPEARED NORMAL WITH NO DAMAGE OR ABNORMALITIES FOUND. THE PHYSICIAN AT THIS TIME THEN SUSPECTED THE RESERVOIR HAD FOLDED ONTO ITSELF OR THE TUBING HAD GOTTEN KINKED. THE PATIENT HAS A HISTORY OF WORKING OUT AT THE GYM A SIGNIFICANT AMOUNT AND THEY DID NOT FOLLOW POST-OPERATIVE IMPLANT ORDERS TO WAIT ON HEAVY ABDOMINAL EXERCISES WHICH THE PHYSICIAN SUSPECTS ATTRIBUTED TO THE MALFUNCTION. THE PHYSICIAN RESET THE PUMP AND CYCLED THE DEVICE NUMEROUS TIMES AND ADDED FLUID TO THE RESERVOIR TO ENSURE IT STAYED FLAT. THE PHYSICIAN THEN SHORTENED TUBING AND MADE A NEW CONNECTION. THE PATIENT FULLY RECOVERED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260655 ↗
• InjuryMay 18, 2026Migration

  IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE ATTENDED A FOLLOW UP VISIT WITH THEIR PHYSICIAN AND DESCRIBED DISCOMFORT IN THE LEFT INGUINAL AREA. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE RESERVOIR WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN IDENTIFIED RESERVOIR HERNIATION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort

  MAUDE report 25210477 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AN INFECTION NEAR THE AREA OF THE RESERVOIR. A SURGICAL PROCEDURE WAS PERFORMED, TO REMOVE AND REPLACE THE IPP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25166411 ↗
• InjuryMay 6, 2026Mechanical Problem; Migration

  IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED ABDOMINAL PAIN. DURING CONSULTATION, THE PHYSICIAN ATTEMPTED TO CYCLE THE DEVICE WITHOUT SUCCESS. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN NOTED THAT THE RESERVOIR HAD HERNIATED FROM THE SPACE OF RETZIUS INTO THE BLADDER, WHICH WAS ASSOCIATED WITH THE PATIENT ABDOMINAL PAIN. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 25107650 ↗
• InjuryMay 4, 2026Fluid/Blood Leak; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071301 ↗
• InjuryApr 28, 2026Inflation Problem; Malposition of Device; Migration

  IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) EXHIBITED AUTO INFLATION ISSUES. IMAGING WAS OBTAINED AND REVEALED THAT THE RESERVOIR WAS FOLDED OVER ITSELF, POTENTIALLY CAUSING EXCESS PRESSURE WITHIN THE SYSTEM. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE CONCEAL RESERVOIR WAS EXPLANTED AND A 65 CC SPHERICAL RESERVOIR WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020802 ↗
• InjuryApr 22, 2026Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) STATED HE WAS UNABLE TO INFLATE HIS DEVICE, WITH THE RESERVOIR COLLAPSING. THE PATIENT WAS EVALUATED BY HIS PHYSICIAN, AND THE SURGEON RECOMMENDED REPLACEMENT WITH A DEVICE FROM A DIFFERENT MANUFACTURER. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-BSC DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957416 ↗
• InjuryApr 22, 2026Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) COULD NOT PUMP THE DEVICE. UPON INSPECTION, FLUID LOSS IN THE RESERVOIR WAS NOTICED. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957414 ↗