Escort II G21603Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002216037), received between Aug 24, 2018 and Nov 11, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K953951); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2019Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ESCORT II EXTRACTION BALLOON. THE DEVICE DID NOT DEBALLOONING [DEFLATE] IN THE BILE DUCT AFTER BILE DUCT STONE REMOVAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE COOK EXTRACTION BALLOON. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304530 ↗
• MalfunctionAug 24, 2018Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ESCORT II EXTRACTION BALLOON (EBL-12-200). THE EBL BALLOON DID NOT DEBALLOONING [DEFLATE] IN THE BILE DUCT AFTER THE BILE DUCT STONE REMOVAL PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7812587 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K953951. One submission often covers many models, so check the product and lot details in each record.

• Z-0068-04 · Aug 28, 2002 · Terminated
  Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4