Cook G09767Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Ultrathane · Class U · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002097674), received between Feb 5, 2018 and Sep 13, 2024 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (8 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 15, 2024Open, Classified
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Z-2223-2024 · Root cause: Labeling Change Control · FDA record ↗
Most reported problems
Device problems
- Difficult to Remove8
- Break2
- Detachment of Device or Device Component1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information3
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2024Difficult to Remove; Difficult to Remove
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
MAUDE report 20218110 ↗MalfunctionAug 3, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
THE DEVICE WAS RETURNED TO COOK. UPON RECEIPT OF THE DEVICE, IT WAS NOTED THAT THE FLEXIBLE STIFFENER WAS LODGED INSIDE THE CATHETER, AND THE HUB WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17454735 ↗MalfunctionMar 27, 2023Break; Difficult to Remove; Break; Difficult to Remove
IT WAS REPORTED IN ADDITIONAL INFORMATION THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE USING NEW INVENTORY/FRESH DRAIN. CLARIFICATION WAS RECEIVED THAT THE RIGID STIFFENER WAS UTILIZED DURING THE DRAIN PLACEMENT PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16620616 ↗MalfunctionMar 20, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT A PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. DURING PLACEMENT OF THE CATHETER, THE STIFFENER WAS DIFFICULT TO REMOVE FROM THE CATHETER. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. TWO OTHER INCIDENTS OF DIFFICULT STIFFENER REMOVAL FOR THIS PATIENT HAVE BEEN CAPTURED IN REPORTS WITH PATIENT IDENTIFIER: (B)(6).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16573855 ↗MalfunctionMar 20, 2023Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16573456 ↗MalfunctionFeb 7, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance
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
MAUDE report 16312379 ↗MalfunctionNov 12, 2019Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9312422 ↗MalfunctionNov 12, 2019Difficult to Remove; Difficult to Remove
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9312280 ↗MalfunctionFeb 5, 2018Break; Break
THE CUSTOMER REPORTED THAT THE PLASTIC STIFFENER BECAME STUCK INSIDE OF THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DURING AN ILEAL CONDUIT DRAIN PLACEMENT. THE PHYSICIAN BEGAN TO PULL ON THE STIFFENER, AND IT REPORTEDLY BROKE OFF INSIDE THE DRAINAGE CATHETER. THE DRAINAGE CATHETER WAS SUBSEQUENTLY REMOVED AND A NEW DEVICE WAS PLACED TO COMPLETE THE PROCEDURE, WITH NO FURTHER ADVERSE EVENTS RESULTING AND NO ADDITIONAL PROCEDURES BEING NECESSITATED. THE DEVICE WAS ONLY IN PLACE IN THE PATIENT'S URETER FOR A FEW MINUTES. THE COMPLAINT DEVICE HAS BEEN RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7243012 ↗
Other CATHETER, NEPHROSTOMY devices
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- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- 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.