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Super XL Enema System 901203Recalls & reported problems

Bracco Diagnostics Inc. · SXL w/Att. (Silicone Cuff) · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815112020986), received between Dec 31, 2020 and Dec 31, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Leak/Splash1
  • Off-Label Use1
  • Use of Device Problem1

Patient problems

  • Hemorrhage/Blood Loss/Bleeding1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 31, 2020Leak/Splash; Off-Label Use; Use of Device Problem; Leak/Splash; Off-Label Use; Use of Device Problem

    THIS REPORT WAS RECEIVED BY A BRACCO DISTRIBUTOR FROM A HEALTHCARE PROFESSIONAL ON 08-DEC-2020 AND WAS SENT TO BRACCO DRUG SAFETY UNIT ON THE SAME DAY (08-DEC-2020). THIS CASE WAS INITIALLY ASSESSED AS NON-REPORTABLE ON 09-DEC-2020. ON 10-DEC-2020, ADDITIONAL INFORMATION WAS PROVIDED, AND CASE WAS RE-ASSESSED AS REPORTABLE DUE TO POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. PATIENT IDENTIFIERS WERE NOT PROVIDED, THEY ARE CONFIDENTIAL DUE TO PRIVACY CONCERNS. ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THE REPORTER STATED THAT SINCE (B)(6) OF 2020, AN UNSPECIFIED NUMBER OF INPATIENTS AND OUTPATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATION AND COMPUTERIZED TOMOGRAPHY (CT) SCAN(S) WITH RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN (MEGLUMINE AMIDOTRIZOATE, SODIUM AMIDOTRIZOATE) (MAH, BAYER PHARMACEUTICALS) (OFF LABEL USE) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. THE REPORTER ALSO STATED THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE W

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

    MAUDE report 11100619 ↗

Other Catheter, Retention, Barium Enema With Bag devices

All Catheter, Retention, Barium Enema With Bag devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.