Cook G10048Recalls & reported problems
Cook Incorporated · Ultrathane, Mac-Loc, Biliary Drainage Catheter Set with Neff Percutaneous Access Set · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00827002100480), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).
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
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2017Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKAGE CAME PERFORATED, THERE WAS A TEAR IN THE PRODUCT PACKAGING FILM. 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. THIS OBSERVATION WAS MADE BY A DISTRIBUTION FACILITY AND THE PRODUCT DID NOT REACH A POINT OF USE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7034565 ↗
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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