ConcealRecalls & reported problems across all models

We found 2 models of Conceal by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 640 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2018 and Sep 30, 2026 — classified as 602 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Migration” (300 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

Most reported Conceal problems

Conceal models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Conceal 720185-01

  Prosthesis, Penis, Inflatable
  586 reports
• Conceal 720182-01

  Prosthesis, Penis, Inflatable
  54 reports

Recent Conceal adverse event reports

The 15 most recent reports across all models, 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 ↗

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