Groshong NXT Catheter 7957505Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00801741035449), received between Mar 11, 2016 and Sep 15, 2026 — classified as 3 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (30 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779000 ↗
• MalfunctionAug 26, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458124 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211082 ↗
• MalfunctionMay 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED WHEN A NURSE WENT TO THE PATIENT¿S ROOM TO CHECK ON HIM, SHE FOUND THAT THE RED CONNECTOR HAD COME LOOSE. THE PATIENT WAS QUITE ACTIVE. THE INCIDENT OCCURRED APPROXIMATELY 10 DAYS AFTER THE PLACEMENT OF THE CATHETER. AFTER RECEIVING THE DEFECTIVE PRODUCT, THE WARD MANAGER INSERTED IT INTO THE CATHETER, SO IT APPEARED TO BE IN NORMAL CONDITION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155990 ↗
• MalfunctionMay 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT MEDICATION IS LEAKING OUT FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135339 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER INSERTING THE CATHETER, HEALTH PROFESSIONAL FLUSHED IT WITH HEPARIN, BUT SINCE THE SOLUTION POOLED NEAR THE INSERTION SITE, HEALTH PROFESSIONAL CONCLUDED THAT THE CATHETER HAD RUPTURED AND REMOVED IT. UPON INSPECTING THE CATHETER AFTER REMOVAL, HEALTH PROFESSIONAL CONFIRMED THAT IT WAS LEAKING AT APPROXIMATELY 34.5 CM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960909 ↗
• MalfunctionApr 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC WAS INSERTED (B)(6) AND STARTED TRANSFUSION. HEALTH PROFESSIONAL SAID IT WAS A LITTLE DIFFICULT TO INFUSE. THE NEXT DAY, LEAKAGE WAS CONFIRMED AT THE TIME OF FLUSHING. LEAKED OUT NEAR, VICINITY 33CM TO 34CM AND DAMAGED. THERE WAS NO REPORTED PATIENT INJURY. LEAKAGE DUE TO CATHETER BREAKAGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769033 ↗
• MalfunctionMar 4, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT DURING ROUTINE SALINE FLUSH, THE STATLOCK PORTION BECAME WET, CONFIRMING LEAKAGE FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. PLACEMENT FOR APPROXIMATELY 6 MONTHS. LEAKAGE FROM THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508538 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MEDICATION IS LEAKING FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821494 ↗
• MalfunctionNov 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED CATHETER INSERTED INTO THE RIGHT UPPER ARM OF A PATIENT WITH BRAIN DISEASE ONE MONTH AGO. PRIOR TO USE, THERE WAS RESISTANCE TO INJECTION, AND WE RECEIVED A REPORT THAT THE EXTENSION SWELLED WHEN SALINE WAS INJECTED, AND WE CONFIRMED ITS PATENCY. THE SAME PHENOMENON WAS CONFIRMED WHEN 10CC OF PREFILLED SALINE WAS POURED INTO THE LUMEN. RED LUMEN. THERE WAS NO BLOCKAGE IN THE WHITE LUMEN, SO IT WAS REMOVED AFTER THE INTENDED ANTIBIOTIC ADMINISTRATION WAS COMPLETED. A BLOOD CLOT HAD FORMED IN THE LUMEN ABOUT 7CM FROM THE INSIDE OF THE VALVE. SWELLING OF THE EXTENSION TUBE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584792 ↗
• MalfunctionOct 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CRACK APPEARED IN THE ROUTE (BLUE) NEAR THE SUTURE WING, MAKING THE RED ROUTE UNUSABLE. IT WAS REPORTED THAT FLUSHING CAUSED LEAKAGE. A NEW CATHETER WAS PLACED. THERE WAS NO DELAY IN TREATMENT OR ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420408 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LIQUID LEAKS DURING USE (CURRENTLY UNKNOWN WHERE IT IS LEAKING FROM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22446109 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6), A GROSHONG DUAL WAS INSERTED INTO THE RIGHT UPPER ARM TO ADMINISTER MEDICATION TO A PATIENT WITH HEART FAILURE. ON (B)(6), THE NURSE IN CHARGE NOTICED THAT THE PATIENT'S CLOTHES WERE WET. SUSPECTING THE CATHETER TO BE DAMAGED, IT WAS REMOVED THE SAME DAY. THE NURSE IN CHARGE COMMENTED THAT THERE WAS A HOLE IN THE EXTERNAL, UNDRESSED PART. THERE WAS A REPORT OF DELIRIUM AND IT WAS SUGGESTED THAT THE EXTERNAL CATHETER WAS NOT COVERED BY A DRESSING AND MAY HAVE BEEN PULLED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960947 ↗
• MalfunctionMay 1, 2025Misassembled; Misconnection; Misassembled; Misconnection

  IT WAS REPORTED THAT ON 2/4 PICC INSERTED VIA RIGHT ULNAR VEIN, ABOUT 27 CM, 22 MAR NURSE CALL FROM PATIENT AT 15:30, FOUND PICC DETACHED FROM FIXTURE. THE PATIENT SAID THAT IT GOT CAUGHT WHEN HE TRIED TO LIE DOWN. PICC REINSERTION. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941874 ↗
• MalfunctionOct 9, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS FOUND IN A TORN CONDITION. VISUALLY, IT APPEARS TO HAVE BEEN CUT WITH A SHARP OBJECT. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20411787 ↗
• MalfunctionSep 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE IS A LEAKAGE OF CHEMICAL FROM ¿WHITE PART¿ OF RECALLED PRODUCT. THE BLUE INDWELLING CATHETER IS DESIGNED TO COME OUT OF THE WHITE BIFURCATION PART, AND WHEN INJECTED FROM THE WHITE DISTAL SIDE, LEAKAGE IS OBSERVED FROM THE BLUE CATHETER SIDE NEAR THE CONNECTION BETWEEN THE BIFURCATION PART AND THE BLUE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311641 ↗
• MalfunctionSep 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED AFTER PUNCTURING THE PATIENT, THE PROCEDURE WAS CANCELED DUE TO POOR SHAPE OF THE SHEATH INTRODUCER. THE PROCEDURE WAS PERFORMED AGAIN USING THE SAME ITEM IN THE HOSPITAL'S INVENTORY AND THE PROCEDURE WAS COMPLETED. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION 09/03/2024: THE ON-SITE COMMENT WAS THAT "THE ENTIRE SHEATH WAS BENT," AND JUDGING FROM THE ABOVE DESCRIPTION OF "BURRS, TEARS, AND BLOOMS". AFTER INSERTING THE SHEATH (BENT IN THE MAIN BODY), THE CATHETER WAS INSERTED THROUGH THE SHEATH, AND THE SHEATH WAS GRADUALLY PEELED OFF (PERFORMING ACTION), BUT HALFWAY THROUGH, THE BENT PART OF THE SHEATH MADE IT IMPOSSIBLE TO PEEL OFF, AND THE PROCEDURE WAS INTERRUPTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304906 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A FEW DAYS AFTER THE CATHETER WAS INSERTED, IT WAS DISCOVERED TO HAVE FRACTURED AND WAS REPLACED WITHOUT ANY HEALTH PROBLEMS. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805775 ↗
• MalfunctionMay 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE PREPARING TO INSERT THE PICC, DISCOVERED THAT THE CATHETER HAD CRACKS. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341778 ↗
• MalfunctionMay 16, 2024Material Frayed; Material Frayed

  IT WAS REPORTED, "THE GUIDEWIRE STRETCHED DURING INSERTION. THERE WAS NO REPORTED PATIENT INJURY. IT MAY HAVE GOTTEN CAUGHT IN THE TIP OF THE NEEDLE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335084 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED THAT CATHETER INSERTED INTO RIGHT UPPER ARM ON APRIL 10. THE AREA AROUND THE PUNCTURE SITE WAS CLAMPED WITH A SUTURE WING AND SECURED WITH STATLOCK. ALL OF THE CATHETER PART (BLUE) THAT WAS OUTWARDLY EXPOSED WAS PASTED AND FIXED WITH A DRESSING TO COVER IT. ON (B)(6), THE CATHETER WAS FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281027 ↗
• MalfunctionMay 2, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING PART OF A GROSHONG CATHETER WAS SHREDDED FROM THE CONNECTOR. IT IS POSSIBLE THAT IT WAS PULLED. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235623 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT AFTER PLACEMENT OF THE GROSHONG CATHETER, THE DUAL LUMEN JUNCTION WAS RUPTURED. IT WAS MENTIONED THAT THE STATLOCK WAS FIXED IN THE WRONG POSITION AND THAT EXTERNAL PRESSURE MAY HAVE BEEN THE CAUSE OF THE TEAR. WE ARE PULLING UP THE PRODUCT TO CONFIRM THAT THERE WAS NO PRODUCT-RELATED PROBLEM, JUST TO BE SURE. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION 03/08/2024: IT WAS REPORTED, "THE COMPLETE BREAK HAS CAUSED A RUPTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004472 ↗
• MalfunctionFeb 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER PICC PLACEMENT, WHEN FLUSHING WAS PERFORMED, THE EXTENSION TUBE ON THE RED CONNECTION SIDE EXPANDED LIKE A BALLOON, SO USE WAS DISCONTINUED. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18726243 ↗
• MalfunctionFeb 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CATHETER WAS INSERTED UNDER FLUOROSCOPY, AND AFTER BLOOD WAS DRAWN, AIR WAS DRAWN FROM LUMEN. THERE WAS NO REPORTED PATIENT INJURY. 1/18/2024 ADDITIONAL INFORMATION: IT WAS REPORTED IT IS UNKNOWN IF THE BREAK OR HOLE WAS INTERNAL OR EXTERNAL AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635343 ↗