Rear Tip ExtenderRecalls & reported problems across all models
Boston Scientific Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 6 models of Rear Tip Extender by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2018 and Dec 30, 2025 — classified as 15 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (9 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
Reports received per month, all models
Most reported Rear Tip Extender problems
Device problems
- Inadequacy of Device Shape and/or Size9
- Device Contaminated During Manufacture or Shipping3
- Inflation Problem2
- Insufficient Device Problem Information2
- Mechanical Problem2
- Adverse Event Without Identified Device or Use Problem1
- Collapse1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Known Impact Or Consequence To Patient5
- Abscess1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Complaint, Ill-Defined1
- Discomfort1
- Erosion1
- Foreign Body In Patient1
Rear Tip Extender models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Rear Tip Extender 72404323Prosthesis, Penis, Inflatable8 reports
- Rear Tip Extender 72404322Prosthesis, Penis, Inflatable5 reports
- Rear Tip Extender 72404321Prosthesis, Penis, Inflatable2 reports
- Rear Tip Extender 72404324Prosthesis, Penis, Inflatable2 reports
- Rear Tip Extender 72404330Prosthesis, Penis, Inflatable2 reports
- Rear Tip Extender 72404320Prosthesis, Penis, Inflatable1 report
Recent Rear Tip Extender adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING THE PREPARATION OF AN IMPLANTATION OF THIS INFLATABLE PENILE PROSTHESIS (IPP) STACKABLE RTES WERE OPENED BY THE CIRCULATOR AND PASSED TO THE SCRUB TECHNICIAN, THE PACKAGING WAS NOT DAMAGED PRIOR TO OPENING. THE SCRUB TECH PREPPED THE IPP CYLINDERS AND DUMPED THE RTES OUT ONTO THE BACK TABLE TO ATTACH THEM TO THE CYLINDERS AND NOTED A HAIR ON ONE OF THE RTES. THE HAIR WAS INSIDE THE PACKAGING. AS A RESULT, THE PROCEDURE WAS COMPLETE WITH ANOTHER RTE. THE TECH RETAINED THE CONTAMINATED RTES TO SHOW HER MANAGER, BUT NO PICTURES WERE AVAILABLE. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23922901 ↗InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD SCROTAL SWELLING AND INFECTION DUE TO AN ABSCESS WITH DRAINAGE ENTIRE INFLATABLE PENILE PROSTHESIS (IPP) REMOVED. A SURGICAL PROCEDURE WAS PERFORMED TO REPLACE THE SYSTEM WITH A TACTRA MALLEABLE PENILE PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: Abscess; Swelling/ Edema; Unspecified Infection
MAUDE report 21562182 ↗InjurySep 18, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT, DURING THIS INFLATABLE PENILE PROSTHESIS (IPP) ORIGINAL PROCEDURE, A DISTAL CROSSOVER OF THE CYLINDERS OCCURRED WHILE IMPLANTING THE COMPONENTS. IN ADDITION, WHEN PLACING THE RIGHT CYLINDER, ITS REAR TIP EXTENDER (RTE) DETACHED. THE MEDICAL STAFF ATTEMPTED TO RETRIEVE IT BUT WAS UNABLE TO LOCATE IT WITHIN THE CORPORA; THEREFORE, A CYSTOSCOPY WAS PERFORMED, DURING WHICH THE RTE WAS VISUALIZED. HOWEVER, DESPITE MULTIPLE ATTEMPTS OVER SEVERAL MINUTES TO RETRIEVE IT, THE EFFORTS WERE UNSUCCESSFUL, SO IT WAS DECIDED TO IMPLANT THE CYLINDER AND COMPLETE THE PROCEDURE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: Foreign Body In Patient; Unspecified Tissue Injury
MAUDE report 20247346 ↗InjuryAug 9, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE REAR TIP EXTENDERS OF THIS INFLATABLE PENILE PROSTHESIS (IPP) WERE REPLACED WITH SMALLER ONES DUE TO POTENTIAL EROSION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Erosion
MAUDE report 19950077 ↗InjuryFeb 21, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) THAT WAS NOT POSITIONED TO REACH THE CORONAL GROVE OF THE PENIS. THE PATIENT EXPERIENCED THE TIP OF THE PENIS DROOPING AND COLLAPSING WHEN THE DEVICE WAS FULLY INFLATED. THE IPP REAR TIP EXTENDERS WERE REPLACED, AND THE PHYSICIAN SUSPECTED THAT THE ORIGINAL IMPLANT WAS MEASURED TOO SHORT WHEN IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18749888 ↗MalfunctionNov 29, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT, DURING THE PREPARATION STATE OF AN INFLATABLE PENILE PROSTHESIS IMPLANT SURGERY, THE MEDICAL STAFF IDENTIFIED A HAIR IN THE STERILE PACKAGE OF THESE REAR TIP EXTENDERS (RTES); THEREFORE, A DIFFERENT PACKAGE OF RTES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18234810 ↗MalfunctionJul 11, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT, DURING THE PREPARATION FOR A PENILE PROSTHESIS PROCEDURE, A FOREIGN MATERIAL INSIDE THE STERILE PACKAGING OF THE REAR TIP EXTENDERS (RTES) WAS DETECTED; THEREFORE, THOSE RTES WERE NOT UTILIZED. OTHER RTES WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17302191 ↗InjuryFeb 3, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY DUE TO DISCOMFORT IN THE SCROTUM. UPON EXPLORATION, THE PHYSICIAN DETERMINED THAT THE PATIENT NEEDED SHORTER REAR TIP EXTENDERS (RTES), THEREFORE THE RTES WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Discomfort
MAUDE report 16292501 ↗InjuryApr 20, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY IN WHICH THE RIGHT REAR TIP EXTENDER, WHICH WAS TOO LONG, WAS REMOVED AND REPLACED WITH A SHORTER ONE. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14160956 ↗InjuryDec 7, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INFLATABLE PENILE PROSTHESIS (IPP) REVISION SURGERY BECAUSE THE PHYSICIAN FELT LIKE THE PATIENT WAS UNDERSIZED BY ABOUT A HALF OF A CENTIMETER. THE 1.5 AND 1.0 RTES WERE REMOVED AND REPLACED WITH 3.0 RTES. THERE WERE NO PATIENT COMPLICATIONS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12952143 ↗InjuryMar 31, 2021Mechanical Problem; Inadequacy of Device Shape and/or Size; Mechanical Problem; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT EXPERIENCED BUCKLING WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DUE TO INCORRECT REAR TIP EXTENDER (RTE) SIZING AS THEY WERE TOO LONG. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE RTES WERE REMOVED AND REPLACED FOR SHORTER ONES. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS RELATED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11599466 ↗MalfunctionMar 29, 2021Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED ON (B)(6) 2021 TO HAVE THE INFLATABLE PENILE PROSTHESIS REPLACED AS AFTER 2 YEARS OF IMPLANT. THE DEVICE NEVER SEEMED TO GET TO 100% HARDNESS AND SEEMED TO HAVE LOST SOME LENGTH AND GIRTH. THE ENTIRE PUMP MECHANISM DEFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11585246 ↗InjuryFeb 17, 2021Disconnection; Migration; Disconnection; Migration
IT WAS REPORTED THAT AFTER THE FIRST ATTEMPT TO INTRODUCE THE RIGHT INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER THE 2 CM REAR TIP EXTENDER (RTE) GOT STUCK DUE A TIGHT CORPUS CAVERNOSUM, DETACHED ITSELF FROM THE CYLINDER AND MIGRATED TOWARDS THE CRURA OF THE PENIS. THIS COMPLICATED THE PROCEDURE AS IT TOOK AN HOUR AND A HALF MORE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO REMOVE THE RTE AND REPLACE IT WITH A 1.5 CM RTE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER PATIENT COMPLICATIONS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11340475 ↗InjuryMay 4, 2020Collapse; Inflation Problem; Mechanical Problem; Collapse; Inflation Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT HAD THE INFLATABLE PENILE PROSTHESIS REMOVED DUE TO MALFUNCTION AS THE DEVICE FAILED TO ERECT PROPERLY. NO AIR OR HOLES WERE OBSERVED, BUT THE PUMP BULB STAYED FLAT. A NEW INFLATABLE PENILE PROSTHESIS WAS IMPLANTED, THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE AND THE EVENT RESOLVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10022443 ↗InjuryJan 15, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO REAR TIP EXTENDERS (RTE'S) BEING OVERSIZED WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP REMAINS IMPLANTED AND ACTIVE AND ONLY THE RTE'S WERE EXPLANTED. ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT PRESENTED TO THE PHYSICIAN BUCKLING WHEN INFLATED AND PAIN AND THE PATIENT IS POSITIVE FOLLOWING THE PROCEDURE.
Patient problems: Pain
MAUDE report 9592787 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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