D.A.S.H. G25620Recalls & reported problems
Cook Incorporated · Howell D.A.S.H. Extraction Balloon with Multiple Sizing · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002256200), received between Jun 14, 2017 and Feb 2, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Deflation Problem2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2018Deflation Problem; Deflation Problem
DURING AN UNKNOWN PROCEDURE, THE PHYSICIAN CHOSE A COOK D.A.S.H. MULTIPLE SIZE EXTRACTION BALLOON. THE REPORTER STATED THAT THERE WAS "A BAD BALLOON CHANNEL" AND THAT THEY HAD DIFFICULTIES DEFLATING THE BALLOON. THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON AND USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7238063 ↗MalfunctionJun 14, 2017Deflation Problem; Deflation Problem
DURING A STONE REMOVAL PROCEDURE, THE PHYSICIAN USED A COOK D.A.S.H. MULTIPLE SIZE EXTRACTION BALLOON. THE BALLOON DID NOT DEFLATE. THE ENDOSCOPE HAD TO BE REMOVED OUT [OF THE PATIENT] AND THE PHYSICIAN BROKE THE BALLOON TO TAKE IT OUT FROM THE DUODENOSCOPE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6640084 ↗
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 410235FPEdwards Lifesciences LLC · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection1 recall0 reports
- 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
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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