Neff G08426Recalls & reported problems
Cook Incorporated · Neff Percutaneous Access Set With Nitinol Wire Guide · Class 1
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002084261), received between Sep 1, 2016 and Sep 12, 2025 — classified as 5 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component5
- Material Separation5
- Difficult to Remove3
- Unraveled Material2
- Detachment Of Device Component1
- Device Contaminated During Manufacture or Shipping1
- Difficult to Advance1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Foreign Body In Patient4
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Unraveled Material; Unraveled Material
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 23041141 ↗MalfunctionSep 1, 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 17671381 ↗InjuryOct 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SHEATH IN A NEFF PERCUTANEOUS ACCESS SET SEPARATED AT THE HUB. THE DEVICE WAS REQUIRED FOR A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) PROCEDURE AND WAS ADVANCED INTO THE PATIENT. THE SHEATH AND A WIRE WERE IN PLACE. WHEN THE WIRE WAS REMOVED, THE WHITE HUB SEPARATED FROM THE BLACK SHEATH, AND THE BLACK COMPONENT WAS RETAINED IN THE PATIENT. HOWEVER, ALL COMPONENTS WERE RETRIEVED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 15632469 ↗MalfunctionJun 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO INSERTING A NEFF PERCUTANEOUS ACCESS SET DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE, THE USER DISCOVERED THE SET WAS "FAULTY". AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE WAS RECEIVED BY COOK ON 21JUN2022 AND IT WAS NOTED THE HUB HAD SEPARATED FROM THE SHEATH, THUS PROMPTING THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14829830 ↗MalfunctionMar 8, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THE INTRODUCER OF A NEFF PERCUTANEOUS ACCESS SET SEPARATED. THE DEVICE WAS BEING USED FOR PLACEMENT OF BILATERAL COOK NEPHROSTOMY DRAINS. DURING THE PROCEDURE, THE RADIOLOGIST NOTED THE TWO PARTS OF THE INTRODUCER WITHIN THE NEFF SET WERE SEPARATED. FURTHER CLARIFICATION INDICATED THE SEPARATION OCCURRED AT THE DISTAL TIP. THE DAMAGED INTRODUCER WAS REMOVED FROM THE PATIENT. ADDITIONALLY, ALL FRAGMENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13687268 ↗InjuryNov 4, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 12750631 ↗InjurySep 24, 2021Detachment of Device or Device Component; 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
MAUDE report 12529077 ↗MalfunctionSep 24, 2021Detachment of Device or Device Component; 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
MAUDE report 12528862 ↗MalfunctionJul 21, 2020Material Separation; Difficult to Advance; Material Separation; 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 Known Impact Or Consequence To Patient
MAUDE report 10304263 ↗InjuryJun 19, 2020Material Separation; Material Separation
IT WAS ORIGINALLY REPORTED THAT TWO DEVICES WERE FELT RESISTANT AND SCRATCHY ON MANIPULATING AND APPEARED "DAMAGED" ON REMOVAL. A THIRD DEVICE WAS REPORTED TO HAVE SEPARATED IN THE PATIENT. THE PRODUCTS WERE RETURNED ON (B)(6) 2020 AND SHOWED SEPARATION OF TWO WIRES. EXAMINATION OF THE THIRD WIRE SHOWED NO MALFUNCTION. THE FIRST WIRE THAT SEPARATED IS REPORTED UNDER MEDWATCH REPORT NUMBER: 1820334-2020-01335. THE SECOND WIRE THAT SEPARATED WITH A PORTION RETAINED IN THE PATIENT IS REPORTED UNDER MEDWATCH REPORT NUMBER: 1820334-2020-01157 (THIS REPORT).
Patient problems: Foreign Body In Patient
MAUDE report 10174932 ↗MalfunctionAug 7, 2019Material Integrity Problem; Material Integrity Problem
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 8871265 ↗MalfunctionMar 5, 2019Unraveled Material; Unraveled Material
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 8391259 ↗MalfunctionSep 10, 2018Fitting Problem; Fitting Problem
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7860347 ↗MalfunctionMar 5, 2018Detachment Of Device Component; Detachment Of Device Component
THE CUSTOMER REPORTED THAT, WHILE THE NEFF PERCUTANEOUS ACCESS SET WAS BEING PREPPED ON THE STERILE TRAY, THE OUTER COVERING OF THE SHEATH OF THE DEVICE BROKE AWAY FROM THE REST OF THE PRODUCT LATER DESCRIBED AS THE HUB FELL OFF. THE MALFUNCTION OCCURRED PRIOR TO USE ON A PATIENT; ACCORDINGLY, NO PATIENT ADVERSE EVENTS RESULTED AS A RESULT OF THE ISSUE. THE CUSTOMER CONFIRMED THAT NO FURTHER COMPLICATIONS AROSE FROM THE DEVICE PROBLEM. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE FOR RETURN; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: No Patient Involvement
MAUDE report 7315389 ↗MalfunctionJul 20, 2017Difficult 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 Code Available
MAUDE report 6728045 ↗InjuryDec 27, 2016Material Separation; Material Separation
DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) DRAIN INSERTION ON A PATIENT WITH BILIARY STENOSIS FOLLOWING A LIVER TRANSPLANT, THE NEEDLE WAS INSERTED FOLLOWED BY THE WIRE. DUE TO THE STENOSIS, THE WIRE BECAME TANGLED AND WHEN THE PHYSICIAN TRIED TO REMOVE IT, THE WIRE SNAPPED. NO OTHER KIT WAS BEEN USED AT THE TIME AND THE BROKEN BIT REMAINS IN THE PATIENT. THE RADIOLOGISTS DECIDED TO LEAVE BUT POSSIBLE PROCEDURES ARE IN THE PLANNING.
Patient problems: Foreign Body In Patient
MAUDE report 6206548 ↗MalfunctionSep 1, 2016Difficult to Remove; Stretched; Difficult to Remove; Stretched
IT WAS REPORTED DURING A NEPHROSTOMY INSERTION PROCEDURE AN ATTEMPT WAS MADE TO WITHDRAW A WIRE THROUGH A PUNCTURE NEEDLE, BUT RESISTANCE WAS FELT. THE OPERATOR ATTEMPTED TO ADVANCE THE WIRE THROUGH THE PUNCTURE NEEDLE, BUT WAS UNABLE TO ADVANCE IT. DURING THE ATTEMPTED REMOVAL OF THE WIRE TENSION WAS APPLIED TO THE WIRE. AFTER REMOVAL IT WAS NOTICED THAT THE WIRE HAD ELONGATED. FLUOROSCOPY CONFIRMED THAT NO RESIDUAL WIRE REMAINED INSIDE THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5922474 ↗
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- IV Administration Set 490062B. Braun Medical Inc. · ACCESSORIES, CATHETER1 recall0 reports
- Neff G10544Cook Incorporated · ACCESSORIES, CATHETER45 reports
- Cook G06299Cook Incorporated · ACCESSORIES, CATHETER18 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.