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RUSCH IPN054586Recalls & reported problems

Teleflex Incorporated · RUSCH Large Leg bag with Easy-Tap & PVC Extension Tubing · Class 1

All models of RUSCH (220)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704645753), received between Jul 1, 2021 and Aug 22, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 16, 2026.

Most reported problems

Device problems

  • Material Rupture3
  • Insufficient Device Problem Information1

Patient problems

  • Insufficient Information3
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 22, 2023Material Rupture; Material Rupture

    IT WAS REPORTED THAT "PATIENT SAID HE GOT BLOOD CLOTS WHILE USING LEG BAGS AND THEY BROKE. PATIENT SAID THE BLOOD CLOT GOT STUCK AT TOP HOSE ATTACHED TO LEG BAG AND HE USED GARDEN WIRE TO TRY AND GET IT UNSTUCK, AND THE HOSE BROKE. PATIENT STATES BOTTOM NOZZLE TOO TIGHT TO OPEN. NO MEDICAL INTERVENTION WAS REPORTED". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS #3011137372-2023-00214 AND 3011137372-2023-00211.

    Patient problems: Insufficient Information

    MAUDE report 17596185 ↗
  • MalfunctionAug 22, 2023Material Rupture; Material Rupture

    IT WAS REPORTED THAT "PATIENT SAID HE GOT BLOOD CLOTS WHILE USING LEG BAGS AND THEY BROKE. PATIENT SAID THE BLOOD CLOT GOT STUCK AT TOP HOSE ATTACHED TO LEG BAG AND HE USED GARDEN WIRE TO TRY AND GET IT UNSTUCK, AND THE HOSE BROKE. PATIENT STATES BOTTOM NOZZLE TOO TIGHT TO OPEN. NO MEDICAL INTERVENTION WAS REPORTED". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS #3011137372-2023-00214 AND 3011137372-2023-00212.

    Patient problems: Insufficient Information

    MAUDE report 17596149 ↗
  • MalfunctionAug 22, 2023Material Rupture; Material Rupture

    IT WAS REPORTED THAT "PATIENT SAID HE GOT BLOOD CLOTS WHILE USING LEG BAGS AND THEY BROKE. PATIENT SAID THE BLOOD CLOT GOT STUCK AT TOP HOSE ATTACHED TO LEG BAG AND HE USED GARDEN WIRE TO TRY AND GET IT UNSTUCK, AND THE HOSE BROKE. PATIENT STATES BOTTOM NOZZLE TOO TIGHT TO OPEN. NO MEDICAL INTERVENTION WAS REPORTED". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED. SEE ASSOCIATED MDRS #3011137372-2023-00211 AND 3011137372-2023-00212.

    Patient problems: Insufficient Information

    MAUDE report 17596064 ↗
  • MalfunctionJul 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    SHE DOES NOT LIKE THE BAGS WE SENT BECAUSE THEY CAUSE AN INFECTION ON HER SKIN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12100853 ↗

Other BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE devices

All BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE devices →

Sources and updates

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