AMS 700 Accessory Kit 72401850Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00878953001135), received between Oct 11, 2018 and Aug 14, 2026 — classified as 28 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Fluid/Blood Leak; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255924 ↗
• MalfunctionJul 13, 2026Deflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT INFLATING AND DEFLATING PROPERLY, AND THE DEVICE HAD FLUID LOSS. THE DEVICE REMAINS IMPLANTED AND A REVISION SURGERY IS PLANNED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25807865 ↗
• MalfunctionMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE INVOLVING AN INFLATABLE PENILE PROSTHESIS (IPP) WAS CANCELLED DUE TO UNSPECIFIED REASONS. THERE WERE NO PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605971 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent an Inflatable Penile Prosthesis (IPP) procedure for erectile dysfunction, but the surgery was not completed due to a urethral injury that occurred during catheter placement. Cystoscopy confirmed urethral erosion. The Accessory Kit was opened but not used, and the procedure was aborted. There were no further patient complications reported.

  Patient problems: Erosion; Unspecified Tissue Injury

  MAUDE report 23882955 ↗
• InjuryOct 9, 2025Inflation Problem; Air/Gas in Device; Inflation Problem; Air/Gas in Device

  IT WAS REPORTED THAT THE INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED INFLATION ISSUES, THE PATIENT NEEDS TO TAKE SEVERAL PUMPS TO START INFLATING. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH WAS OBSERVED AIR IN THE SYSTEM, BUT NO HOLES WERE IDENTIFIED. THE IPP WAS REMOVED AND REPLACE WITH A NEW ONE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23261875 ↗
• MalfunctionJul 29, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, DURING AN INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT PROCEDURE, THE MEDICAL STAFF OPENED THE ACCESSORY KIT AND FOUND A HAIR IN THE CONTAINER, A DIFFERENT ACCESSORY KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22652569 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER GENERAL ANESTHESIA, THIS PROCEDURE WAS CANCELLED BECAUSE THE INFLATABLE PENILE PROSTHESIS DID NOT NEED TO BE REPLACED. DURING THE PREPARATION STATE, AN ACCESSORY KIT WAS OPENED BUT NOT USED. THERE WERE NO DEVICE ISSUES REPORTED AND NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277739 ↗
• MalfunctionFeb 27, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO THIS PROCEDURE A HOLE WAS FOUND IN THE STERILE PACKAGE OF THE ACCESSORY KIT OF AN INFLATABLE PENILE PROSTHESIS (IPP). THE PROCEDURE WAS COMPLETED USING ANOTHER KIT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788036 ↗
• InjuryFeb 23, 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 EXPERIENCED PERSISTENT SCROTAL PAIN FOLLOWED BY DRAINAGE 1-2 WEEKS POST IMPLANT PROCEDURE. THE DEVICE WAS ULTIMATELY EXPLANTED. THE PATIENT IS NOW EXPERIENCING MULTIPLE CULTURES GROWING M FORTUITUM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Bacterial Infection; Fluid Discharge; Pain

  MAUDE report 18768122 ↗
• MalfunctionJan 18, 2024Contamination; Contamination

  IT WAS REPORTED THAT WHILE PREPARING THE IMPLANT TABLE, THE SCRUB NURSE AND REP NOTICED A SMALL HAIR IN THE CAP OF THE KEITH NEEDLE HOLDER. ANOTHER NEEDLE WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURY OR FURTHER DEVICE ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535156 ↗
• MalfunctionNov 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A HAIR FOUND IN AN ACCESSORY KIT. THE KIT WAS OPENED AND PLACED ON STERILE SURFACE, BUT NOT USED. THE PROCEDURE WAS CANCELED DUE TO A SPIDER FALLING FROM THE CEILING ONTO THE STERILE FIELD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222545 ↗
• MalfunctionMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CATHETER COULD NOT BE PLACED DURING THE PROCEDURE; THEREFORE, THE PROCEDURE WAS CANCELLED. IT WAS NOTED THAT THE PATIENT HAD ALREADY BEEN ADMINISTERED GENERAL ANESTHESIA. THERE WERE NO DEVICE ISSUES AND NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR THE PROCEDURE ABORTED AFTER PATIENT SEDATION WITH GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993760 ↗
• MalfunctionApr 27, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A HAIR WAS FOUND IN THE ACCESSORY KIT. ANOTHER KIT WAS USED TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828651 ↗
• InjuryJul 29, 2022Inflation Problem; Connection Problem; Inflation Problem; Connection Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO THE DEVICE NOT PROPERLY EXPANDING. THE PHYSICIAN BELIEVED THAT THE ISSUE WAS CAUSED BY THE PLUG FROM THE ACCESSORY KIT AT THE PUMP BECAME LOOSE. A NEW IPP WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131114 ↗
• InjuryJul 5, 2022Migration; Migration

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDERS FLUSHED OUT OF THE URINARY TRACT; THEREFORE, THE PATIENT UNDERWENT A RECONSTRUCTIVE PENOPLASTY TO REPAIR THE DAMAGED URETHRA; ALSO, THE CYLINDERS WERE REMOVED AND REPLACED WITH NEW ONES. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Perforation

  MAUDE report 14917989 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION WITH THEIR INFLATABLE PENILE PROSTHESIS (IPP) CONTROL PUMP AND THAT THE PUMP WAS EXPOSED. THE COMPONENT WAS REMOVED AND A PROCEDURE WAS SCHEDULED TO IMPLANT A NEW PUMP ON A FUTURE DATE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Erosion

  MAUDE report 14757098 ↗
• InjuryFeb 8, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT PERFORMING AS INTENDED AFTER FOUR MONTHS OF IMPLANT. A REPAIR PROCEDURE WAS PERFORMED AND THE DOCTOR ADJUSTED THE DEVICE. NO COMPONENTS WERE REMOVED OR REPLACED. THE DEVICE WAS FUNCTIONAL AFTER THE PROCEDURE AND THE EVENT WAS RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477397 ↗
• MalfunctionDec 27, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING A MALFUNCTIONING INFLATABLE PENILE PROSTHESIS (IPP) PUMP. A PATIENT OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13089689 ↗
• MalfunctionAug 19, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING PREPARATION OF THE IMPLANT TABLE PRIOR TO SURGERY, THE SCRUB TECH NOTICED A PARTICLE IN THE INJECTABLE SALINE THAT WAS DESIGNATED FOR THE IMPLANT PREPARATION. THE PARTICLE WAS REMOVED AND STUDIED BY THE SCRUB TECH, CIRCULATING NURSE, AND SALES REPRESENTATIVE. THE PARTICLE WAS BELIEVED TO HAVE BEEN A PIECE OF THE 22 GAUGE HYPONEEDLE CAP THAT BROKE OFF. THE INJECTABLE SALINE WAS THEN DISCARDED AND REPLACED. THE SYRINGES WERE REPLACED AND THE HYPONEEDLES WERE FLUSHED TO REMOVED ANY POTENTIAL PARTICLES. NO FURTHER RESOLUTION STEPS WERE NECESSARY AFTER THIS. THERE WERE NO PATIENT COMPLICATIONS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343761 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS THE PHYSICIAN WAS DILATING THE CORPORA, HE NOTED THAT THE URETHRA WAS INJURED DURING DISSECTION. THE CASE WAS CANCELLED. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Perforation

  MAUDE report 11928927 ↗
• InjuryApr 27, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REVISE AN INFLATABLE PENILE PROSTHESIS(IPP) CYLINDERS DUE TO MIGRATION OF THE DEVICE INTO THE SCROTUM. THE EXISTING CYLINDERS AND PUMP WERE REMOVED AND REPLACED WITH A NEW PAIR OF CYLINDERS AND A PUMP; THE EXISTING RESERVOIR CONTINUES TO BE USED. A PATIENT OUTCOME OF FULLY RECOVERED WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734598 ↗
• InjuryDec 10, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) REAR TIP EXTENDER (RTE) EXPLANTED BECAUSE THE LENGTH WAS TOO SHORT. A NEW RTE WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10982441 ↗
• InjuryOct 29, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE CYLINDER STRENGTH BEING WEAK WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP REMAINS IMPLANTED AND ACTIVE AND SALINE WAS ADDED TO THE RESERVOIR. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10756847 ↗
• InjuryAug 17, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DUE TO A MALFUNCTION FROM TWISTING OF THE CONNECTING TUBE AND CONNECTOR TIP CRACK THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) REVISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10417873 ↗
• InjuryJul 21, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PROCEDURE TO ADD SALINE TO THE INFLATABLE PENILE PROSTHESIS(IPP) RESERVOIR DUE TO THE CYLINDER STRENGTH BEING WEAK. NO DEVICE WAS REMOVED OR REPLACED. A PATIENT OUTCOME OF STABLE WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10305066 ↗