Neff G04267Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002042674), received between Jul 28, 2016 and Jun 16, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 15 most recent of 15 reports, 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 ↗
• 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 ↗
• 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 12, 2024Material Separation; Unraveled Material; Difficult to Advance; Material Separation; Unraveled Material; Difficult to Advance

  IT WAS REPORTED BY THE PHYSICIAN THAT THE WIRE INCLUDED IN THE NEFF PERCUTANEOUS ACCESS SET WAS "FLAWED." IT WAS LATER NOTED THAT THE WELD BETWEEN THE SOFTER AND STIFFER PORTIONS OF THE WIRE WOULD NOT FIT INTO THE 22G NEEDLE. THE DEVICE WAS RETURNED TO THE MANUFACTURER ON 10APR2024 FOR EVALUATION. DURING THE PRELIMINARY DEVICE FAILURE ANALYSIS, IT WAS FOUND THAT THE WIRE GUIDE HAD UNRAVELED. 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 19098675 ↗
• MalfunctionJan 10, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A FOREIGN PARTICLE WAS FOUND IN THE STERILE PACKAGING OF NEFF PERCUTANEOUS ACCESS SET. 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 18486966 ↗
• MalfunctionMay 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN 80 YEAR-OLD MALE PATIENT REQUIRED SNARE RETRIEVAL FOR A SEPARATED PORTION OF A WIRE GUIDE IN A NEFF PERCUTANEOUS ACCESS SET. THE NEFF PERCUTANEOUS ACCESS SET WAS BEING USED TO ACCESS THE PATIENT'S KIDNEY. ONCE THE CHIBA NEEDLE WAS IN PLACE, THE INNER STYLET WAS REMOVED, AND THE .018 WIRE WAS ADVANCED WITH NO DIFFICULTIES OR RESISTANCE. WHEN THE WIRE WAS PULLED BACK, THE TIP OF THE WIRE WAS NO LONGER ATTACHED TO THE BODY OF THE WIRE. THE TIP OF THE WIRE WAS RETRIEVED WITHIN THE SAME PROCEDURE WITH A SNARE KIT. THE PROCEDURE WAS THEN COMPLETED, AND THE NEPHROSTOMY TUBE WAS SUCCESSFULLY INSERTED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956379 ↗
• MalfunctionNov 20, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material

  PRELIMINARY EXAMINATION OF THE DEVICE RETURNED (B)(6) 2020 SHOWED THE WIRE UNRAVELED AND THE WELD BALL MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10875683 ↗
• MalfunctionDec 10, 2019Device 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 Patient Involvement

  MAUDE report 9443821 ↗
• MalfunctionSep 17, 2019Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED SINCE THE SUBMISSION OF THE LAST REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075974 ↗
• MalfunctionJul 26, 2019Material Separation; Material Separation

  SEE H10.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8832580 ↗
• MalfunctionSep 25, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT UPON INSPECTION OF THE RECEIVED PRODUCT (AUGUST-NO OTHER INFORMATION PROVIDED), THE AFFILIATE DISTRIBUTOR IDENTIFIED A PARTICLE INSIDE THE PACKAGING OF A NEFF PERCUTANEOUS ACCESS SET.

  Patient problems: No Patient Involvement

  MAUDE report 7906954 ↗
• MalfunctionApr 12, 2018Material Frayed; Material Frayed

  CUSTOMER REPORTED THAT, DURING THE DEPLOYMENT OF A NEFF PERCUTANEOUS ACCESS SET FOR A BILIARY DRAIN, IT WAS NOTED THAT THE TIP OF THE OUTER SHEATH WAS "FRAYED". THE DEVICE MADE CONTACT WITH THE PATIENT, BUT THE CUSTOMER WAS UNABLE TO FINISH PLACEMENT OF THE DEVICE. A SECOND DEVICE WAS USED TO FINISH THE PROCEDURE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7426960 ↗
• MalfunctionJan 8, 2018Material Frayed; Material Frayed

  THE CUSTOMER REPORTED THAT THE BLACK INTRODUCER SHEATH OF THE NEFF PERCUTANEOUS ACCESS SET FRAYED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN PROVIDED. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, 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 7173153 ↗
• InjuryAug 3, 2016Material Frayed; Material Frayed

  IT WAS REPORTED DURING A NEPHROSTOMY PROCEDURE A WIRE SHREDDED DURING REMOVAL FROM THE DILATOR. THE PHYSICIAN WAS ABLE TO SNARE TO REMOVE THE WIRE. THERE WAS NOT ANY PART OF THE DEVICE THAT DETACHED WITHIN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 5844051 ↗
• InjuryJul 28, 2016Disconnection; Disconnection

  DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) AND DRAIN INSERTION PROCEDURE ON THE (B)(6) MALE PATIENT WITH PRE-EXISTING CONDITION OF BILIARY OBSTRUCTION, THE COAXIAL SET WAS INSERTED OVER THE WIRE WITHOUT ISSUE. IN ADDITION, THE INNER STYLET NEEDLE WAS REMOVED AND A .035 WIRE WAS INSERTED THROUGH THE PLASTIC OUTER SHEATH. HOWEVER, AS THE SHEATH WAS BEING REMOVED OVER THE WIRE, THE HUB DISCONNECTED FROM THE CATHETER. THE CATHETER PORTION HAD TRAVELED ALONG THE WIRE AND WAS UNABLE TO BE RETRIEVED USING FINGERS OR FORCEPS. THE PHYSICIAN WAS REQUIRED TO USE DIATHERMY AND MAKE A LARGER INCISION TO VISUALIZE THE CATHETER TUBING. THE PHYSICIAN WAS ABLE TO SNARE A SMALL SECTION AT THE TIP AND WAS ABLE TO ANCHOR USING A SUTURE AND REMOVE IT BY PULLING THE SUTURE OVER THE WIRE. THE INCISION WAS SUTURED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Code Available

  MAUDE report 5828791 ↗