Neff G10544Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00827002105447), received between Jul 20, 2017 and Apr 6, 2026 — classified as 3 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (21 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

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 4, 2024Material Separation; Material Separation

  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 20370979 ↗
• MalfunctionOct 1, 2024Unraveled 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 20346294 ↗
• MalfunctionSep 30, 2024Unraveled 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 20335484 ↗
• MalfunctionSep 11, 2024Unraveled 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; Pain

  MAUDE report 20196949 ↗
• MalfunctionAug 20, 2024Material Separation; Material Separation

  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 20000434 ↗
• MalfunctionJun 28, 2024Unsealed Device Packaging; Unsealed Device Packaging

  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 19634107 ↗
• MalfunctionMar 25, 2024Difficult to Remove; Stretched; Unraveled Material; Difficult to Remove; Stretched; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE FROM A NEFF PERCUTANEOUS ACCESS SET UNRAVELED DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE PROCEDURE. AFTER SUCCESSFUL PUNCTURE WITH THE ACCESS NEEDLE, BILE FLOW WAS OBSERVED. THEN THE WIRE WAS INTRODUCED INTO THE BILE DUCT. AFTER REACHING THE BILE DUCT, IT WAS FOUND THAT THE WIRE GUIDE COULD NOT BE WITHDRAWN THROUGH THE NEEDLE. UPON REMOVAL, IT WAS DISCOVERED THAT THE FRONT END OF THE WIRE GUIDE ELONGATED AND UNRAVELED. USE OF THE WIRE WAS IMMEDIATELY DISCONTINUED. 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 18972222 ↗
• MalfunctionMar 18, 2024Unsealed Device Packaging; Component Missing; Unsealed Device Packaging; Component Missing

  IT WAS REPORTED THAT THE STERILE PACKAGE OF A NEFF PERCUTANEOUS ACCESS SET WAS MISSING A SEAL. AS A RESULT, THE 22 GAGE NEEDLE WAS MISSING FROM THE PACKAGE. THE DEVICE WAS NOT USED. AS REPORTED, A 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 18924518 ↗
• InjuryJan 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE GUIDEWIRE INCLUDED IN THE NEFF PERCUTANEOUS ACCESS SET BROKE. DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTCD) PROCEDURE IN THE BILE DUCT OF A MALE PATIENT, THE DOCTOR EXPERIENCED RESISTANCE AT THE WIRE TIP WHILE REMOVING THE 0.018 GUIDEWIRE ALONG THE INTRODUCER SHEATH. THE PHYSICIAN MADE THE DECISION TO REMOVE THE GUIDEWIRE AND INTRODUCER SHEATH TOGETHER AS A UNIT. UPON REMOVAL, IT WAS DISCOVERED THAT A 1.4MM SECTION OF THE GUIDEWIRE WAS BROKEN AND REMAINED UNDER THE SKIN OF THE PATIENT. THE FRAGMENT WAS LATER REMOVED IN AN ADDITIONAL GENERAL SURGERY ON (B)(6) 2023. THE PHYSICIAN BELIEVES THAT THE TIP OF THE NEEDLE DAMAGED THE GUIDEWIRE AS IT WAS USED TO FIND THE TARGET.

  Patient problems: Foreign Body In Patient

  MAUDE report 18428081 ↗
• MalfunctionAug 3, 2023Unraveled Material; Difficult to Advance; Unraveled Material; 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 17454634 ↗
• InjuryJun 23, 2023Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED, THAT THE WIRE GUIDE INCLUDED IN THE NEFF PERCUTANEOUS ACCESS SET UNRAVELED. AND SEPARATED DURING A LIVER TRANSCUTANEOUS CHOLANGIOGRAPHY PROCEDURE ON A 76-YEAR-OLD MALE PATIENT. IT WAS NOTED, THAT THE WIRE GUIDE "BEHAVED DIFFERENTLY THAN USUAL", DURING INSERTION INTO THE BILE DUCT. THE WIRE AND NEEDLE WERE REMOVED FROM THE PATIENT AS A UNIT. UPON REMOVAL FROM THE PATIENT, IT WAS FOUND THAT THE WIRE HAD UNRAVELED AND SEPARATED. LEAVING AN UNINTENDED PORTION OF THE WIRE INSIDE OF THE PATIENT. THE PHYSICIAN, THEN OPENED AN UNKNOWN COPE WIRE TO CONTINUE THE PROCEDURE. BUT FOUND THAT IT ALSO BEHAVED DIFFERENTLY, AND REPORTED THAT IT HAD BEEN "BITTEN" BY THE NEEDLE. A SECOND NPAS KIT WAS OPENED TO OBTAIN THE WIRE, THAT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT IS CURRENTLY, UNKNOWN IF THE PORTION OF SEPARATED WIRE WILL BE RETRIEVED FROM THE PATIENT. ADDITIONAL INFORMATION REGARDING EVENT AND DEVICE DETAILS HAVE BEEN REQUESTED, BUT ARE CURRENTLY UNAVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17194912 ↗
• MalfunctionJun 16, 2023Unraveled 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 17143588 ↗
• MalfunctionJun 13, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THE PACKAGING OF A NEFF PERCUTANEOUS ACCESS SET WAS NOT SEALED. PER CUSTOMER, ONE SIDE OF THE PACKAGED PRODUCT WAS OBSERVED NOT TO BE SEALED COMPLETELY. NO PATIENT CONTACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121304 ↗
• MalfunctionJun 8, 2023Difficult to Remove; Unraveled Material; Difficult to Advance; Difficult to Remove; Unraveled Material; Difficult to Advance

  IN ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER 14JUN2023, IT WAS REPORTED THAT THE WIRE GUIDE DID NOT UNRAVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088483 ↗
• MalfunctionMar 23, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  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 16598552 ↗