Skater™ Biliary Drainage Catheter Non-Locking 8 Fr x 40 cmRecalls & reported problems
Argon Medical Devices, Inc. · Skater™ Biliary Drainage Catheter Non-Locking ( 8 Fr x 40 cm) · Class 2 · Implant
Data updated Oct 18, 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 00886333001347), received between Aug 11, 2021 and Aug 11, 2021 — classified as 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2021Adverse Event Without Identified Device or Use Problem
WHEN THE DOCTOR WANTED TO CHANGE THE PIGTAIL, THEY FOUND THE PIGTAIL WAS LEFT IN THE PATIENT'S BODY. BECAUSE OF THE COVID-19 PANDEMIC SO THE DOCTOR JUST DISPOSED THIS PRODUCT RIGHT AWAY, BUT IN THIS CASE WE HAVE THE PICTURES AS THE EVIDENCE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12309865 ↗
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- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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