Neff G10460Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002104600), received between Dec 19, 2016 and Jun 7, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2024Break; Material Separation; Break; 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 19489941 ↗
• MalfunctionJun 29, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN THE NEFF PERCUTANEOUS ACCESS SET UNRAVELED DURING AN INSERTION PROCEDURE ON AN UNKNOWN PATIENT. THE WIRE WAS ABLE TO BE REMOVED IN ITS ENTIRETY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE 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 17226781 ↗
• MalfunctionNov 13, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT, AS THE WIRE WAS BEING CHANGED OUT OF THE NEFF PERCUTANEOUS ACCESS SET, THE WIRE TIP CAUGHT IN THE NEEDLE AND SNAPPED IN THE TROCAR. THE CUSTOMER CONFIRMED THAT NO PATIENT ADVERSE EVENTS OR ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THIS OCCURRENCE. THE CUSTOMER INDICATED THE PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY PROCEDURE, ULTIMATELY FAILED. THE CUSTOMER STATED THE FAILURE WAS UNRELATED TO THE PRODUCT MALFUNCTION. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN, BUT AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7026372 ↗
• MalfunctionOct 9, 2017Difficult to Remove; Sticking

  IT WAS REPORTED DURING THE PATIENT'S PERCUTANEOUS TRANS-HEPATIC CHOLANGIOGRAPHY PROCEDURE, THE INTRODUCER ASSEMBLY BECAME STUCK AND THE USER WAS UNABLE TO WITHDRAW THE GUIDE WIRE, THE DILATOR AND THE CANNULA ASSEMBLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6931235 ↗
• InjuryMar 10, 2017Unraveled Material; Unraveled Material

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING CATHETER PLACEMENT USING A NEFF PERCUTANEOUS ACCESS SET. THE WIRE UNRAVELED NEAR THE TIP WHILE IN THE PATIENT. THE CIRCUMSTANCES AND HANDLING SURROUNDING THE DEVICE PLACEMENT ARE NOT KNOWN. THE WIRE WAS FORCIBLY REMOVED AND GUIDANCE ACCESS TO THE INTENDED BILIARY SYSTEM WAS LOST. NO SECTIONS OF THE DEVICE REMAINED WITHIN THE PATIENT. THE PHYSICIAN PLACED A NEW WIRE TO REGAIN ACCESS AND SUCCESSFULLY COMPLETED THE PROCEDURE. NO FURTHER ADVERSE CONSEQUENCES WERE REPORTED. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: No Code Available

  MAUDE report 6395108 ↗
• InjuryDec 19, 2016Break; Break

  IT WAS REPORTED THE ¿FRAGILITY OF THE MICRO-GUIDE, PROBABLY CRACKED DURING ITS PLACEMENT AND IT HAS A FRAYED ASPECT.¿ THE REPORTER INDICATED IT WAS IMPOSSIBLE TO REMOVE THE DEVICE COMPLETELY AND A DISTAL FRAGMENT WAS LEFT IN INTRAHEPATIC DESPITE PROGRESSIVE MANIPULATION. THE COMPLAINT FORM SUBMITTED INDICATED IN THE PATIENT OUTCOME SECTION A FRAGMENT WAS NOT LEFT IN THE PATIENT. ANOTHER DEVICE WAS USED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6184861 ↗