Cook G10959Recalls & reported problems
Cook Incorporated · Universal Curved Drainage Catheter Ultrathane · Class U · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002109599), received between Nov 26, 2020 and Dec 16, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (2 reports).
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
Device problems
- Material Separation2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2020Material Separation; Material Separation
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE INTRO-TIP DESIGN CURVED UNIVERSAL DRAINAGE CATHETER FOR A CHEST TUBE PLACEMENT PROCEDURE. AFTER PLACEMENT, THE OPERATOR REPORTED THE "DRAINAGE CATHETER CAME LOOSE FROM THE CONNECTOR." ON THE FOLLOWING DAY, THE DEVICE WAS REMOVED AND A SECOND DEVICE OF THE SAME LOT WAS PLACED. THIS CAUSED THE PATIENT TO BE HOSPITALIZED AN EXTRA DAY. HOWEVER, THE SECOND DEVICE SEPARATED DURING THE PROCEDURE. THE DEVICE WAS REMOVED AND A THIRD DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED. THE FIRST DEVICE IS CAPTURED UNDER MEDWATCH REPORT # (B)(4). THE SECOND DEVICE IS CAPTURED UNDER PATIENT IDENTIFIER (B)(6) (THIS REPORT).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11021347 ↗InjuryNov 26, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 10908952 ↗
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- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.