Covidien 8884720221ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521661721), received between Mar 11, 2025 and Apr 29, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Unintended Deflation

  THE CUSTOMER REPORTED THE EXCHANGE WAS CARRIED OUT AND AFTER 5 DAYS THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028381 ↗
• MalfunctionNov 20, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED A G-TUBE DISLODGMENT DUE TO THE BULB DEFLATING. NURSING BELIEVES THE G-TUBE BULB HAS A LEAK WHICH IS CAUSING THE G-TUBE BULB TO DEFLATE AND LEADING TO DISLODGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610488 ↗
• MalfunctionAug 15, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT DURING VITAL SIGNS IT WAS NOTED THAT THE PATIENT'S GASTROSTOMY TUBE WAS DISPLACED/OUTSIDE WHICH WAS REPORTED TO THE SUPERVISOR AND THE ON-DUTY DOCTOR. SUBSEQUENTLY, A CALL WAS MADE TO THE ON-DUTY SURGEON WHO REVIEWED AND PERFORMED A DEVICE CHANGE. THEY STATED THAT THE GASTROSTOMY BALLOON WAS CRYSTALLIZED CAUSING IT TO BE DISPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816165 ↗
• MalfunctionAug 14, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT BULBS ARE DEFLATING BECAUSE OF HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812562 ↗
• MalfunctionJun 5, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT A BALLOON TEST WAS PERFORMED AND THE BALLOON SHOWED A SMALL AMOUNT OF RETURN. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151453 ↗
• MalfunctionMar 11, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED A GASTROSTOMY TUBE WITH A BALLOON DEFECT WAS EVIDENT, WHICH EXPLAINS THE ACCIDENTAL DISLODGEMENT. THE STOMA IS HEALTHY WITH SLIGHT GASTRIC SECRETION THROUGH THE STOMA WHICH IS CLEANED WITH SALINE SOLUTION. AN 18MM CATHETER WAS PASSED TO PREVENT CLOSURE OF THE STOMA, IT WAS VERIFIED THAT IT WAS IN THE GASTRIC CAVITY BY MEANS OF AUSCULTATION BY INSUFFLATION OF 20 CC OF AIR AND GASTRIC RESIDUE. THE BALLOON WAS INFLATED WITH 10CC STERILE WATER, IT WAS CONNECTED TO A COLLECTION BAG. THE ATTENDING PHYSICIAN WAS INFORMED. SE EVIDENCIA SONDA DE GASTROSTOMÍA CON DEFECTO EN BALÓN, LO CUAL EXPLICA LA SALIDA ACCIDENTAL, ESTOMA SANO, CON LEVE SECRECIÓN GÁSTRICA POR ESTOMA, LA CUAL SE LIMPIA CON SOLUCIÓN SALINA, SE REALIZA PASO DE SONDA FOLEY 18 PARA EVITAR CIERRE DE ESTOMA, SE COMPRUEBA QUE SE ENCUENTRA EN CAVIDAD GÁSTRICA POR MEDIO DE AUSCULTACIÓN DE INSUFLACIÓN DE 20 CC DE AIRE Y RESIDUO GÁSTRICO, SE INSUFLA BALÓN CON 10 CC DE AGUA ESTÉRIL, Y SE CONECTA A BOLSA RECOLECTORA. SE INFORMA AL MÉDICO TRATANTE. A GASTROSTOMY TUBE WITH A BALLOON DEFECT IS EVIDENT, WHICH EXPLAINS THE ACCIDENTAL DISLODGEMENT, A HEALTHY STOMA, WITH SLIGHT GASTRIC SECRETION THROUGH THE STOMA, WHICH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573899 ↗