Escort II G22262Recalls & reported problems
Cook Incorporated · Escort II Extraction Balloon · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002222625), received between Jul 21, 2025 and Jul 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Deflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2025Deflation Problem; Deflation Problem
DURING AN ERCP WAS BEING PERFORMED IN CBD, THE PHYSICIAN USED A COOK ESCORT II EXTRACTION BALLOON. IT WAS REPORTED [THAT] THE ASSISTANT NURSE TRIED TO DEFLATE THE BALLOON AFTER SWEEPING THE DUCT FOR STONE REMOVAL. HOWEVER, THE BALLOON AIR COULDN'T BE DEFLATED AT ALL. THEY RECOGNIZED THAT IT MUST BE THE PROBLEM WITH THE LUMEN. SO HE CUT THE BALLOON LUMEN. FINALLY, THE BALLOON DEFLATED. THE CASE FINISHED AFTER WITHDREW THE BALLOON OUT OF THE SCOPE. 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 22558604 ↗
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 · TerminatedHowell 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
Other CATHETER, BILIARY, SURGICAL devices
- FOGARTY 410236FPEdwards Lifesciences LLC · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- FOGARTY 410405FPEdwards Lifesciences LLC · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- FOGARTY 410235FPEdwards Lifesciences LLC · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- Fusion Quattro G48225Cook Incorporated · CATHETER, BILIARY, SURGICAL22 reports
- Fusion G31537Cook Incorporated · CATHETER, BILIARY, SURGICAL15 reports
- Fusion Quattro G31922Cook Incorporated · CATHETER, BILIARY, SURGICAL5 reports
- Tri-Ex G26856Cook Incorporated · CATHETER, BILIARY, SURGICAL4 reports
- Fusion Quattro G31921Cook Incorporated · CATHETER, BILIARY, SURGICAL4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.