Groshong NXT Catheter 7857505Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00801741035388), received between Jan 6, 2016 and Dec 10, 2025 — classified as 4 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (27 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INCIDENT THAT OCCURRED ON 30TH OCTOBER WITH THE GROSHONG DUAL LUMEN "BURSTING". TWO NURSING STAFF WERE CARING FOR THE PICC AND FLUSHED AND ASPIRATED BOTH RED AND WHITE LUMENS. ON THE SECOND FLUSH OF WHITE LUMEN, STAFF HEARD AN AUDIBLE "POP" AND FLUSH SOLUTION CAME OUT. THE STAFF THEN CLAMPED WITH ARTERY FORCEPS AND REPORTED ISSUE. PICC HAS SINCE BEEN REMOVED AND REPLACED. UPON FURTHER QUESTIONING, I WAS ABLE TO CLARIFY THAT THERE WAS NO PATIENT IMPACT OTHER THAN DELAY IN TREATMENT AND REPLACEMENT OF PICC LINE. IT WAS CONFIRMED WITH STAFF MEMBER PRESENT AT THE TIME THAT A 10ML SYRINGE WAS USED AND THERE WAS NO OBVIOUS RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773544 ↗
• MalfunctionApr 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE GROSHONG WAS INSERTED ON (B)(6) 2025 WITH REQUESTED REMOVAL FROM CLINICIAN ON (B)(6) 2025 DUE TO PRODUCT FAULT. IT WAS NOTICED ON PULSATILE FLUSHING THE CLEAR SECTION BETWEEN THE HUB AND RED LUMEN "BULGES" OUT. DOCTOR REQUESTED IT TO BE REMOVED. PATIENT UNDERGOING CHEMO, GROSHONG WAS REMOVED AND REPLACED SAME DAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900349 ↗
• MalfunctionJan 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER LINE LEAK AT THE HUB CONNECTION AFTER INSERTION INTO THE PATIENT 2 DAYS. REPORTED TO HAVE CAUSED A DELAY AND PATIENT REQUIRED A NEW PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21131808 ↗
• MalfunctionDec 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 2 GROSHONG PICCS EXPERIENCED A SPLIT. ONE SPLIT IN THE RED LUMEN JUST BELOW THE WHITE BUTTERFLY AND THE OTHER SPLIT IN THE RED LUMEN BETWEEN THE 45 AND 44CM MARKING. BOTH FROM THE SAME LOT NUMBER. THE CUSTOMER ADVISED THAT SHE IS NOT AWARE OF ANY INJURIES, HOWEVER ONE PATIENT DID REQUIRE A NEW PICC TO BE INSERTED. THIS FILE ADDRESSES THE SECOND PICC THAT REQUIRED A NEW PICC TO BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848535 ↗
• MalfunctionDec 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT 2 GROSHONG PICCS EXPERIENCED A SPLIT. ONE SPLIT IN THE RED LUMEN JUST BELOW THE WHITE BUTTERFLY AND THE OTHER SPLIT IN THE RED LUMEN BETWEEN THE 45 AND 44CM MARKING. BOTH FROM THE SAME LOT NUMBER. THE CUSTOMER ADVISED THAT SHE IS NOT AWARE OF ANY INJURIES, HOWEVER ONE PATIENT DID REQUIRE A NEW PICC TO BE INSERTED. THIS FILE ADDRESSES THE FIRST PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848413 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PICC FAULT WITH THE DUAL GROSHONG, THERE SEEMS TO BE A SMALL HOLE IN THE TUBING JUST BELOW THE WHITE BUTTERFLY HUB. IT WAS INSERTED (B)(6) WITH NO PROBLEMS UNTIL YESTERDAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805761 ↗
• MalfunctionJul 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THEY HAD A LEAK WITH A 5 FR PICC LINE. ADDITIONAL INFORMATION RECEIVED ON 7/9/2024: IT WAS REPORTED BY THE CUSTOMER "DURING THE INSTALLATION OF THE CATHETER, WE NOTICED THE PRESENCE OF SEVERAL LEAKS ON IT WHICH CAUSES FLUID LEAKAGE DURING INJECTION IN SEVERAL PLACES ON THE CATHETER SHAFT RATHER THAN ONLY AT THE END OF THE CATHETER ON THE ORIFICE OF IT. THIS MEANS THAT WHEN INJECTING A DRUG, THE FULL DOSE IS NOT DELIVERED AT THE END OF THE CATHETER AS NORMAL THEREFORE WE HAVE TO REPLACE THE CATHETER WITH ANOTHER CATHETER.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19734911 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, "LEAKING CATHETER." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047298 ↗
• MalfunctionJan 9, 2024Material Deformation; Material Deformation

  I T WAS REPORTED THAT TUBING BLOCK/OCCLUSION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475554 ↗
• MalfunctionJan 8, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED "TUBING LEAKAGE". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466479 ↗
• MalfunctionJan 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FAULT WITH A PICC LINE. IT IS SPLIT JUST BELOW THE WHITE BUTTERFLY HUB ON THE WHITE LUMEN SIDE. IT WAS INSERTED (B)(6) 2023, WITH NO ISSUES UNTIL YESTERDAY." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452443 ↗
• MalfunctionDec 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT IT WAS INSERTED ON (B)(6) HOWEVER YESTERDAY THE WARD STAFF NOTICED A SPLIT IN THE LINE. IT IS JUST BELOW THE WHITE BUTTERFLY HUB. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379367 ↗
• InjuryApr 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "THE GROSHONG 5FR DOUBLE LUMEN CATHETER BEGAN TO LEAK AT THE CONNECTION BETWEEN THE DISTAL AND PROXIMAL ROUTES (LUMENS). PATIENT WAS ON A CONTINUOUS INFUSION OF MEDICATION AND HAD NO RESISTANCE, IT STARTED IN ONE ROUTE AND THEN HAPPENED IN THE OTHER. THE PICC LINE WAS REMOVED." NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED 04/25/2023: THE PATIENT IN QUESTION WAS USING VASOACTIVE DRUG, DOBUTAMINE, AND HAD LOSSES DUE TO THE LEAK THAT OCCURRED BETWEEN THE DISTAL AND PROXIMAL PART OF THE CATHETER, THERE WAS NO RESISTANCE OR OBSTRUCTION OF THE CATHETER. WE HAD TO PULL OUT THE PICC CATHETER AND PUNCTURE IT AGAIN. PATIENT IN NEED OF PASSING A SILICONE CATHETER. NEED FOR IMMEDIATE PERIPHERAL VENIPUNCTURE AND THEN IMPLANTATION OF A CENTRALLY INSERTED CENTRAL CATHETER. THERE WAS DAMAGE TO THE PATIENT AS HE WAS RECEIVING DOBUTAMINE THROUGH THE CATHETER AND THERE WAS DRUG LEAKAGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769058 ↗
• MalfunctionDec 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "ON (B)(6) 2022 BLOOD STAINED MILKY FLUID WAS FOUND INSIDE A PATIENT¿S STATLOCK DRESSING. WHEN TAKEN DOWN, THE LINE HAD SPLIT AT THE TRIANGULAR FLANGE WHERE THE TWO LUMENS GO INTO ONE. THE FLUID WAS LEAKING OUT OF ONE SIDE UNDER THE WING. THE OTHER LUMEN WAS BLED BACK AND INFUSIONS WERE SWITCHED ONTO THAT LUMEN, UNFORTUNATELY THE SAME LEAKING OCCURRED. PERIPHERAL LINES PUT IN AND THEN CENTRAL ACCESS GAINED LATER IN THE DAY. THE GROSHONG LINE WAS REMOVED. THE PATIENT WAS NOT HARMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15947144 ↗
• InjuryNov 1, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER "WRITER ASPIRATED CATHFLO FROM WHITE LUMEN OF PATIENT'S PICC, WITHOUT ISSUE, THEN FLUSHED WITH 10 ML NORMAL SALINE WITH EASE. USING SAME AMOUNT OF EVEN PRESSURE, WHEN ATTEMPTING TO FLUSH 2ND 10 ML SYRINGE OF NS, POPPING" SOUND HEARD; CATHETER BLEW AND SEPARATED - SUCH THAT CATHETER TIP STILL CONNECTED WITH SYRINGE IN WRITER'S HAND- BUT CATHETER END STILL CONNECTED TO PATIENT"

  Patient problems: Foreign Body In Patient

  MAUDE report 15708857 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT THE PICC WAS INITIALLY INSERTED ON THE 21ST OF SEPTEMBER. ON THE 27TH, THE DISTAL WHITE LUMEN HAD SNAPPED OFF AND WAS FOUND ON THE FLOOR NEXT TO THE PATIENT'S BEDSIDE. AT THE TIME, THE PICC WAS CAPPED AND NOT ATTACHED TO ANOTHER DEVICE. THE PATIENT CLAIMS HE DID NOT TAMPER WITH THE PICC BUT "SEEMED AGITATED". THE PICC WAS THEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15628819 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER "WRITER ASPIRATED CATHFLO FROM WHITE LUMEN OF PATIENT'S PICC, WITHOUT ISSUE, THEN FLUSHED WITH 10 ML NORMAL SALINE WITH EASE. USING SAME AMOUNT OF EVEN PRESSURE, WHEN ATTEMPTING TO FLUSH 2ND 10 ML SYRINGE OF NS, "POPPING" SOUND HEARD; CATHETER BLEW AND SEPARATED - SUCH THAT CATHETER TIP STILL CONNECTED WITH SYRINGE IN WRITER'S HAND- BUT CATHETER END STILL CONNECTED TO PATIENT, OPEN TO AIR. (THE CATHETER SPLIT IN 2). WRITER IMMEDIATELY PINCHED OFF CATHETER END STILL CONNECTED TO PATIENT." ADDITIONAL INFORMATION PROVIDED 10/12/22: INSERTION: DATE & TIME: (B)(6) 2022, 09:33. EXTERNAL LENGTH: 4 CM. TOTAL CATHETER LENGTH: 46 CM. SITE: RIGHT ARM AND BASILIC. INSERTION SITE ABOVE ANTICUBITAL: 10 CM. ARM CIRCUMFERENCE: 30 CM. INITIAL SECUREMENT DEVICE: SECURACATH. NUMBER OF ATTEMPTS: 1. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? SECURACATH. WHAT THEY¿RE BEING TREATED FOR: MYELOMA. DOES THE PATIENT HAVE AN INFECTIOUS DISEASE? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15608680 ↗
• MalfunctionJul 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC WAS INSERTED ON THE 14TH JUNE. ON THE 4TH JULY, WHILE FLUSHING THE PICC, THE WARD NURSE NOTICED THAT THE PROXIMAL (RED) LUMEN HAD SPLIT. THE SPLIT WAS LOCATED BELOW THE WINGS NEAR THE BLUE CATHETER. THERE WAS NO VISIBLE SPLIT IN THE DISTAL (WHITE) LUMEN. THE NURSE MAY HAVE APPLIED TOO MUCH PRESSURE WHILE FLUSHING IE NOT USING THE CORRECT SIZE SYRINGE TO FLUSH OR INCORRECT FLUSHING TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122809 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "GROSHONG PICC WAS INSERTED IN RADIOLOGY. PATIENT WAS SENT BACK TO SURGICAL WARD AFTER INSERTION. WARD MEDICAL OFFICER WAS ABOUT TO START TREATMENT FOR THIS PATIENT. WHILE HE WAS CHECKING PATENCY, HE FOUND THAT THERE WAS LEAKING AT THE PROXIMAL HUB. HE STOPPED THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316610 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANAPHYLAXIS DURING PICC INSERTION. REPORTED BY IMMUNOLOGIST THAT A PATIENT SUFFERED ANAPHYLAXIS. THE REPORTER IS UNSURE OF THE MEDICAL INTERVENTION AS THE TREATING CLINICIAN IS NO LONGER WITH THE DEPARTMENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 14250447 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ANAPHYLAXIS DURING PICC INSERTION. REPORTED BY IMMUNOLOGIST THAT A PATIENT SUFFERED ANAPHYLAXIS DURING INSERTION OF GROSHONG NXT PICC. MEDICAL INTERVENTION: CODE TEAM CALLED TO XRAY POST PROCEDURE. ADRENALINE, PROMETHAZINE AND HYDROCORTISONE GIVEN. PATIENT TRANSFERRED TO ICU.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 14240501 ↗
• MalfunctionJul 16, 2021Break; Misassembled; Break; Misassembled

  IT WAS REPORTED: "DURING THE HYPER-PRESSURE FLUSHING, THE SYSTEM BETWEEN THE CATHETER HOLDER AND THE CATHETER BECAME DETACHED. CLINICAL CONSEQUENCE OBSERVED: REMOVAL OF THE DEVICE. PRESSURE POINT THE HEMORRHAGIC AREA. ESTABLISHMENT OF A NEW PARENTERAL FEEDING SYSTEM "

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12183450 ↗
• MalfunctionJun 10, 2021Break; Break

  IT WAS REPORTED MATERIAL'S TIP WAS BROKEN WHEN IT WAS GOING TO BE INSTALLED BY PHYSICIAN, THAT WHEN NOTICED THE ISSUE HAS DISCARDED THE MATERIAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11976854 ↗
• MalfunctionJun 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING FROM THE RED PROXIMAL LUMEN, 3 WEEKS POST INSERTION. PICC REMOVED FROM PATIENT AND REPLACED. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938987 ↗
• MalfunctionSep 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID LEAKING UNDER DRESSING WHEN IV FLUID IS ADMINISTRATED. DEVICE REMOVED FROM VESSEL IN UPPER ARM AND NEW PICC LINE PLACED IN MEDICAL IMAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10544530 ↗