NeffRecalls & reported problems across all models
Cook Incorporated · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 97
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 0
We found 7 models of Neff by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2016 and Jun 16, 2026 — classified as 20 injuries, 77 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (31 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Neff problems
Device problems
- Unraveled Material31
- Material Separation28
- Difficult to Remove13
- Break8
- Unsealed Device Packaging8
- Detachment of Device or Device Component6
- Difficult to Advance6
- Device Contaminated During Manufacture or Shipping4
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- No Known Impact Or Consequence To Patient20
- Foreign Body In Patient15
- No Code Available7
- No Consequences Or Impact To Patient7
- No Patient Involvement6
- Device Embedded In Tissue or Plaque1
- No Information1
Neff models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Neff G10544ACCESSORIES, CATHETER45 reports
- Neff G08426ACCESSORIES, CATHETER17 reports
- Neff G04267ACCESSORIES, CATHETER15 reports
- Neff G10797ACCESSORIES, CATHETER10 reports
- Neff G10460ACCESSORIES, CATHETER6 reports
- Neff G10546ACCESSORIES, CATHETER3 reports
- Neff G04593ACCESSORIES, CATHETER1 report
Recent Neff adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Unraveled Material
IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN THE NEFF PERCUTANEOUS ACCESS SET WAS FOUND TO BE UNRAVELED UPON OPENING THE PACKAGE DURING A RIGHT-SIDE GALLBLADDER PUNCTURE FOR A 54-YEAR-OLD FEMALE PATIENT. THE COMPLAINT DEVICE WAS UNABLE TO BE USED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25524581 ↗MalfunctionApr 6, 2026Unraveled Material
IT WAS REPORTED THAT THE WIRE GUIDE FROM A NEFF PERCUTANEOUS ACCESS SET BROKE. THE DEVICE WAS REQUIRED FOR MINIMALLY INVASIVE INTERVENTIONS SUCH AS CARDIAC INTERVENTION AND CEREBROVASCULAR INTERVENTION RELATED TO TUMORS AND PERIPHERAL VASCULAR DISEASE. DURING USE OF THE NEFF SET, THE CANNULA SHEARED THE WIRE GUIDE, AND THE WIRE BROKE. USE OF THIS DEVICE WAS STOPPED IMMEDIATELY, AND A NEW, LIKE-DEVICE WAS OBTAINED TO SUCCESSFULLY COMPLETE THE PUNCTURE AND INTERVENTIONAL SURGICAL TREATMENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790381 ↗MalfunctionMar 10, 2026Unsealed Device Packaging
IT WAS REPORTED THAT PACKAGING OF A NEFF PERCUTANEOUS ACCESS SET WAS MISSING A SEAL. THE PRODUCT HAD NOT BEEN SENT TO A HOSPITAL; THE FAILURE WAS DISCOVERED AT THE DISTRIBUTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24555962 ↗MalfunctionFeb 5, 2026Unraveled Material
IT WAS REPORTED THAT THE WIRE GUIDE FROM A NEFF PERCUTANEOUS ACCESS SET BECAME UNRAVELED. THE 65-YEAR-OLD MALE PATIENT UNDERWENT A PERCUTANEOUS TRANSHEPATIC CHOLANGIODRAINAGE (PTCD) IN WHICH THE STANDARD PERCUTANEOUS INTRODUCTION OF THE INTRODUCER WAS PERFORMED. AFTER SUCCESSFUL PUNCTURE, THEY FOUND THAT THE WIRE GUIDE WOULD NOT ADVANCE SMOOTHLY. THEY IMMEDIATELY WITHDREW THE WIRE GUIDE IN ORDER TO READJUST THE DIRECTION. UPON THE SECOND ATTEMPT TO ADVANCE, A "CUTTING PHENOMENON" AT THE PROXIMAL PORTION OF THE DEVICE WAS NOTED. THE ATTEMPT WAS CONTINUED, BUT THE WIRE GUIDE WAS STILL UNABLE TO ADVANCE SMOOTHLY. THE WIRE GUIDE WAS REMOVED AND REPLACED WITH A NEW LIKE DEVICE, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THOUGH IT WAS SAID THE PROCEDURE WAS TEMPORARILY INTERRUPTED DUE TO THIS ISSUE, THE PATIENT DID NOT EXPERIENCE ANY DISCOMFORT. NO PORTION OF THE WIRE GUIDE REMAINED INSIDE THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A CUSTOMER PROVIDED PHOTO SHOWS THE MANDRIL PROTRUDING FROM THE TOP IF THE WIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24270822 ↗MalfunctionJan 28, 2026Device Endoleak
ADDITIONAL INFORMATION WAS PROVIDED ON 30JAN2026 INDICATING THAT THE WIRE GUIDE STRAIGHTENER WAS NOT USED WHEN ADVANCING THE WIRE GUIDE. THE INITIAL DATE OF AWARENESS FOR THE MANUFACTURER WAS 27JAN2026, NOT 19JAN2026 AS PREVIOUSLY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202309 ↗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 ↗InjuryAug 6, 2025Material Separation; 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 22730121 ↗MalfunctionApr 17, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN THE NEFF PERCUTANEOUS ACCESS SET UNRAVELED DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTCD) PROCEDURE FOR 64-YEAR-OLD MALE PATIENT. DURING THE PROCEDURE, AFTER OPENING THE PRODUCT PACKAGING, THE 0.018" WIRE GUIDE WAS INSERTED INTO THE PATIENT ALONG THE PUNCTURE NEEDLE. UPON ATTEMPTING TO WITHDRAW THE WIRE GUIDE THROUGH THE NEEDLE, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, PREVENTING PROPER REMOVAL. MULTIPLE REMOVAL ATTEMPTS RESULTED IN DAMAGE TO THE WIRE GUIDE'S TIP. TO ENSURE THE SAFETY, A SAME LIKE-DEVICE WAS USED TO CONTINUE THE PROCEDURE. THE ORIGINAL PRODUCT PACKAGING WAS DISCARDED BY THE DEPARTMENT BECAUSE IT WAS IMPROPERLY STORED BY THE NURSE AND BECAME CONTAMINATED WITH DIRT. A PHOTO PROVIDED BY THE CUSTOMER SHOWS AN UNRAVELED WIRE GUIDE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21859421 ↗InjuryApr 3, 2025Material Separation; Material Separation
IT WAS REPORTED IN ADDITIONAL INFORMATION THAT THE WIRE GUIDE WAS NOT MANIPULATED OR REMOVED THROUGH THE ENTRY NEEDLE. THERE ARE NO PLANS TO REMOVE THE SEPARATED PORTION OF THE WIRE GUIDE FROM THE PATIENT. NO TORTUOUS OR CALCIFIED ANATOMY WAS SEEN ON FLUOROSCOPY.
Patient problems: Foreign Body In Patient
MAUDE report 21766742 ↗MalfunctionApr 3, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT NEFF PERCUTANEOUS ACCESS SET PACKAGE WAS FOUND TO BE UNSEALED PRIOR TO USE. A NEW LIKE-DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21762299 ↗MalfunctionApr 3, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING PREOPERATIVE PREPARATION, THE NEFF PERCUTANEOUS ACCESS SET PACKAGE WAS FOUND TO BE UNSEALED. A NEW LIKE-DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21762257 ↗MalfunctionMar 25, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS DISCOVERED BY A DISTRIBUTION FACILITY THAT THE PACKAGING OF ONE NEFF PERCUTANEOUS ACCESS SET WAS UNSEALED. THE PRODUCT DID NOT REACH A POINT OF USE. NO PATIENT CONTACT WAS MADE WITH THE DEVICE. NO ADVERSE EFFECTS HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21691782 ↗MalfunctionDec 6, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE WIRE GUIDE WAS DIFFICULT TO REMOVE FROM THE INTRODUCER SET OF A NEFF PERCUTANEOUS ACCESS SET. DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIODRAINAGE (PTCD), THE INTRODUCER SET WAS SUCCESSFULLY PLACED INTO THE INTRAHEPATIC BILE DUCTS. AFTER THE ACCESS NEEDLE WAS WITHDRAWN, THE WIRE GUIDE WAS ADVANCED INTO THE INTRODUCER SET. HOWEVER, THE TIP END OF THE WIRE GUIDE WAS NOT ABLE TO BE SUCCESSFULLY "SEPARATED" FROM THE INTRODUCER SET AND WAS WITHDRAWN. UPON REMOVING THE WIRE GUIDE, THE INTRODUCER SET COULD NOT BE RE-ENTERED. THE PROCEDURE WAS COMPLETED BY USING A NEW LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. AFTER PERFORMING A PRELIMINARY DEFECTIVE FAILURE ANALYSIS ON THE RETURNED COMPLAINT DEVICE, THE WIRE GUIDE WAS OBSERVED TO BE SEPARATED FROM THE SOLDER JUNCTION POINT THUS PROMPTING THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20865049 ↗MalfunctionNov 8, 2024Material Separation; Unraveled Material; Material Separation; Unraveled Material
IT WAS REPORTED THAT THE GUIDEWIRE INCLUDED IN THE NEFF PERCUTANEOUS ACCESS SET UNRAVELED AND WAS NOT ABLE TO USE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20641496 ↗MalfunctionNov 1, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE WIRE GUIDE FROM A NEFF PERCUTANEOUS ACCESS SET SEPARATED DURING A 4-VESSEL PROCEDURE. AS RESULT, THE DEVICE WAS REMOVED IN ITS ENTIRETY, AND A NEW DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20587381 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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