Cook G10049Recalls & reported problems
Cook Incorporated · Multipurpose Drainage Catheter Set Neff Access Set with Nitinol Wire Guide Ultrathane · Class U · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Cook Neff Access drainage catheter set is used to drain fluid from the kidney. Most of the 27 reports describe problems with the sealed packaging — contamination or foreign matter found in the package, sometimes with a tear in the packaging — plus a few cases of parts breaking, leaking, or coming apart. Three injuries were reported and there were no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00827002100497), received between Oct 18, 2017 and Mar 16, 2026 — classified as 3 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping8
- Tear, Rip or Hole in Device Packaging8
- Break2
- Device Contamination with Chemical or Other Material2
- Fluid/Blood Leak2
- Delivered as Unsterile Product1
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Patient Involvement8
- No Code Available2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2026Break
IT WAS REPORTED THAT THE SUTURE STRING OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET BROKE. THE DEVICE WAS PLACED IN THE RIGHT KIDNEY FOR USE AS A PERCUTANEOUS NEPHROSTOMY TUBE. SOMETIME AFTER THE DEVICE WAS PLACED, THE SUTURE BROKE AND PREVENTED FURTHER PROCEDURES. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THE DEVICE INDWELLING IN THE PATIENT WITH INSERTION SITE COVERED BY A DRESSING. CATHETER SUTURE BREAKAGE IS VISIBLE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24610090 ↗MalfunctionSep 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET HAD FOREIGN MATTER WITHIN THE PACKAGING. AS REPORTED, THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22995898 ↗MalfunctionSep 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET HAD FOREIGN MATTER WITHIN THE PACKAGING. AS REPORTED, THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965077 ↗MalfunctionSep 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT TWO ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SETS HAD FOREIGN MATTER WITHIN THE PACKAGING. AS REPORTED, THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964915 ↗MalfunctionSep 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET HAD HAIR-LIKE FIBER WITHIN THE PACKAGING. AS REPORTED, THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964647 ↗MalfunctionSep 2, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
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 22944460 ↗MalfunctionApr 16, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
THIS EVENT IS NOT CONSIDERED REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY AND/OR REPORTABLE PRODUCT MALFUNCTION. SEE H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19117865 ↗MalfunctionAug 22, 2023Unraveled Material; Unraveled Material
PER ADDITIONAL INFORMATION, THE PROCEDURE WAS COMPLETED BY OPENING A NEW ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET. THE WIRE GUIDE WAS NOT MANIPULATED NOR WITHDRAWN THROUGH THE NEEDLE. IT WAS NOTED THE RADIOLOGIST IS VERY EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17599305 ↗MalfunctionMar 27, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16620182 ↗MalfunctionOct 11, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE PATIENT REQUIRED REPLACEMENT OF A ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET. A RIGHT NEPHROSTOMY PROCEDURE WAS PERFORMED. AFTER THE CATHETER WAS PLACED, LEAKAGE WAS OBSERVED AT THE DISTAL END OF THE CATHETER. THE CATHETER WAS REPLACED WITH A NEW ONE DURING THE SAME PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15580309 ↗MalfunctionAug 19, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT UPON INSPECTION AT THE DISTRIBUTION CENTER, AN UNIDENTIFIED "FOREIGN OBJECT" WAS OBSERVED INSIDE THE PACKAGE. NO PATIENT CONTACT WAS MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15259570 ↗MalfunctionMar 31, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED FOREIGN MATTER WAS FOUND IN THE PACKAGING OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET. THE FAILURE WAS DISCOVERED BY THE DISTRIBUTOR UPON RECEIPT OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13966051 ↗MalfunctionMar 31, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THE PACKAGING OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET WAS PERFORATED. THE FAILURE WAS DISCOVERED BY THE DISTRIBUTOR UPON RECEIPT OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13965619 ↗MalfunctionAug 26, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A PERFORATION WAS DISCOVERED IN THE PRIMARY PACKAGING OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET DURING PHYSICAL INSPECTION AT THE DISTRIBUTION FACILITY. NO PATIENT CONTACT WAS MADE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12371461 ↗MalfunctionOct 20, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10705957 ↗MalfunctionOct 20, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET WAS INSPECTED AT A DISTRIBUTOR. UPON EXAMINATION, PERFORATION OF THE DEVICE PACKAGING WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10705879 ↗MalfunctionSep 30, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET WAS INSPECTED AT A DISTRIBUTOR. UPON EXAMINATION, PERFORATION OF THE DEVICE PACKAGING WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT. EXAMINATION OF THE RETURNED DEVICE RECEIVED 25 SEP 2020 SHOWED A PERFORATION NOT EASILY DETECTABLE TO THE USER.
Patient problems: No Patient Involvement
MAUDE report 10609806 ↗MalfunctionSep 3, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10487840 ↗MalfunctionAug 6, 2019Break; Stretched; Break; Stretched
MalfunctionJun 24, 2019Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8726966 ↗MalfunctionJun 18, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8708364 ↗MalfunctionAug 7, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET WAS USED DURING AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, A LEAK WAS FOUND WHERE THE CATHETER MEETS THE HUB. THE PHYSICIAN REMOVED THE CATHETER AND PLACED A NEW ONE TO COMPLETE THE PROCEDURE SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7756226 ↗MalfunctionJun 25, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED BY THE DISTRIBUTOR THAT DURING INSPECTION, A PIECE OF BLACK HAIR WAS OBSERVED INSIDE OF THE PRODUCT PRIMARY PACKAGING. AS REPORTED, THERE WAS NO PATIENT CONTACT AS THIS DEFECT WAS FOUND DURING INSPECTION.
Patient problems: No Patient Involvement
MAUDE report 7636021 ↗InjuryJun 1, 2018Filtration Problem; Filtration Problem
IT WAS REPORTED A PHYSICIAN OBSERVED FILTRATION ON A ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET; THEREFORE, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO CHANGE THE SET. AS REPORTED, THE PATIENT STATED THE DEVICE HAS CAUSED BLEEDING. TO DATE, ADDITIONAL INFORMATION WITH REGARDS TO THE AMOUNT OF BLOOD LOSS ASSOCIATED WITH THIS STATEMENT IS UNKNOWN.
Patient problems: No Code Available
MAUDE report 7560778 ↗MalfunctionFeb 27, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE INTERNATIONAL CUSTOMER REPORTED THAT AS METAL PARTICLE WAS OBSERVED TO BE INSIDE THE PACKAGING OF THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET. THIS WAS DISCOVERED PRIOR TO USE DURING A STOCK INSPECTION. ACCORDINGLY, THE PRODUCT PROBLEM DID NOT RESULT IN ANY PATIENT ADVERSE EVENTS. THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL IN PROGRESS.
Patient problems: No Patient Involvement
MAUDE report 7301780 ↗
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- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
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- Cook G09767Cook Incorporated · CATHETER, NEPHROSTOMY1 recall9 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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