MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONCEAL; PROSTHESIS, PENIS, INFLATABLE

Model Number	720185-01
Medical Device Problem Codes	Inflation Problem (1310); Nonstandard Device (1420); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404255 serial number: n/a batch/lot number: 1100673378 model/catalog description: lgx preconnect ms 12cm ip iz unique identifier (udi) #: (b)(4).B3: date is unknown, so estimated date was entered.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Inflation issue, reservoir operating differently than intended, and tubing kink are acknowledged within the instructions for use (ifu) and is not related to off label use or failure to follow instructions.Based on the information available, the cause that contributed to the reported event cannot be established; therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
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.

• Brand Name: CONCEAL
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086521217
• MDR Report Key: 25260655
• Report Number: 2124215-2026-27818
• Device Sequence Number: 12120663
• Product Code: JCW
• UDI-Device Identifier: 00878953005669
• UDI-Public: (01)00878953005669(17)270902(10)1100787380
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 1100787380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 09/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0427-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male