Tri-Ex G26856Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002268562), received between Oct 16, 2017 and May 20, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  DURING AN COMMON BILE DUCT STONE REMOVAL, THE PHYSICIAN USED A COOK TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING. THE USER OPENED THE PACKAGE AND PRE-TESTED THE BALLOON BY INFLATING IT WITH AIR, BUT FOUND OUT THERE WAS DIFFICULTY DEFLATING THE BALLOON. THE USER CHANGED TO A NEW ONE TO CONTINUE THE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22053765 ↗
• MalfunctionMar 7, 2025Material Rupture; Material Rupture

  DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) , THE PHYSICIAN USED A TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED THAT AFTER TESTING THE DEVICE, THE BALLOON IS INFLATED IN THE BILE DUCT, HAS NO CONTACT WITH THE STONE, AND WHEN IT IS REMOVED FROM THE BILE DUCT IT IS FOUND WITHOUT PART OF THE LATEX OF THE BALLOON. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DETACHED PORTION OF THE BALLOON WAS RETRIEVED WITH AN EXTRACTOR BASKET. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21546162 ↗
• MalfunctionJul 23, 2018Material Fragmentation; Material Fragmentation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING. THE USER CHECKED THE BALLOON INTEGRITY BEFORE USE WHICH TURNED OUT FINE. THE USER INFLATED THE BALLOON DURING THE PROCEDURE, BUT IT BROKE. THE USER HAS MANY YEARS OF EXPERIENCE USING COOK PRODUCT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 28-JUNE-2018 AND OUR EVALUATION OF THE RETURNED DEVICE DETERMINED PART OF THE BALLOON MATERIAL WAS MISSING AND WAS NOT INCLUDED IN THE RETURN OF THE DEVICE. THIS INFORMATION WAS COMMUNICATED TO THE USER FACILITY AND THE LOCATION OF THE MISSING SECTION IS UNKNOWN. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE LOCATION OF THE MISSING SECTION DETECTED DURING OUR LABORATORY EVALUATION IS UNKNOWN. 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 7711590 ↗
• MalfunctionOct 16, 2017Detachment Of Device Component; Detachment Of Device Component

  IN PREPARATION FOR AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP), THE PHYSICIAN SELECTED A TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING. BEFORE USING THE CATHETER [BALLOON] FOR REMOVAL OF GALLSTONES, THE [PRE] TEST WAS PERFORMED AND THE BALLOON DID NOT INFLATE. BASED ON THE PHOTO PROVIDED BY THE USER FACILITY, THE BALLOON MATERIAL IS MISSING.

  Patient problems: No Patient Involvement

  MAUDE report 6953190 ↗

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