Groshong NXT Catheter 7927505Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00801741035401), received between Apr 11, 2017 and Dec 3, 2025 — classified as 1 injury, 62 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (31 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CATHETER INSERTION ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED THAT HER CLOTHES WERE WET, AND UPON INSPECTION, THE WING OF THE CATHETER WAS FOUND TO BE TORN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705770 ↗
• MalfunctionFeb 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD A GROSHONG CATHETER IMPLANTED ON (B)(6) 2021. AFTER (B)(6) 2022, IT WAS NOT USED FOR MEDICINE ADMINISTRATION, AND THE CATHETER WAS MAINTAINED BY FLUSHING WITH SALINE SOLUTION ONCE A WEEK. ON (B)(6) 2022, WHEN THE CATHETER WAS STARTED USING BY CONNECTING IT TO THE LUMEN OF THE WHITE LUER CONNECTOR TO START CHEMOTHERAPY, AN ALARM TO NOTIFY CATHETER OCCLUSION SOUNDED. THEREFORE, WHEN THE CATHETER WAS FLUSHED WITH SALINE SOLUTION, LEAKAGE OCCURRED NEAR THE 52CM DEPTH MARKING ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13482854 ↗
• MalfunctionOct 21, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PATIENT HAD A GROSHONG CATHETER IMPLANTED ON (B)(6) 2021. THE PROXIMAL PART OF THE CATHETER COULD NOT BE INFUSED THE MEDICINE. THE NEXT WEEK IMPROVED, HOWEVER, THE DISTAL PART OF THE CATHETER COULD NOT BE INFUSED THE MEDICINE AND THE CATHETER OCCLUSION CONTINUED. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT¿S BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12672290 ↗
• MalfunctionOct 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD A GROSHONG CATHETER IMPLANTED ON (B)(6) 2021 THAT LEAKED MEDICINE NEAR THE CATHETER CONNECTOR. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THREE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666616 ↗
• MalfunctionSep 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD A GROSHONG CATHETER IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, LEAKAGE WAS FOUND BETWEEN THE PUNCTURE SITE AND STAT LOCK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12444122 ↗
• MalfunctionJun 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BECAUSE AN ALARM TO NOTIFY INFUSION PUMP OCCLUSION SOUNDED, THE CATHETER AND THE INSERTION SITE WERE CHECKED. BLOOD RETURN FROM BOTH LUMENS OF THE RED AND WHITE WERE NOT CONFIRMED, AND LEAKAGE OCCURRED AROUND THE INSERTION SITE AFTER SALINE SOLUTION WAS INFUSED. WHEN THE DRESSING WAS REMOVED, THE CATHETER WAS KINKED AND A CRACK WAS FOUND ON THE CATHETER. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT¿S BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049015 ↗
• MalfunctionJun 16, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT HAD A GROSHONG CATHETER IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, IT WAS FOUND THAT THE CATHETER CONNECTOR WAS DETACHED FROM THE CATHETER. THE DEVICE WAS REMOVED AND ANOTHER NEW CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013041 ↗
• MalfunctionFeb 26, 2021Fluid/Blood Leak; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT HAD A GROSHONG CATHETER IMPLANTED ON (B)(6) 2021. BLOOD COAGULATION WAS FOUND AROUND THE INSERTION SITE SO THAT EXCHANGED THE DRESSING ON (B)(6) 2021. THEN RESTARTED THE INFUSION AND CHECKED THE LINE, LEAKAGE WAS FOUND AROUND 54-55CM, AND PINHOLE WAS FOUND. THE CATHETER WAS REMOVED AND PLANNED TO IMPLANT ANOTHER ONE ON (B)(6) 2021. THERE WAS NO REPORTED PATITEN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11387580 ↗
• MalfunctionJan 8, 2021Break; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT HAD A GROSHONG CATHETER IMPLANTED ON (B)(6) 2020. THE CATHETER WAS SECURED BY SEVERAL DRESSING, AND THE CATHETER OART WHICH WAS NOT SECURED BY THEM FOUND TO BE BROKEN AND LEAKAGE WAS FOUND ON (B)(6) 2020. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11140490 ↗
• MalfunctionAug 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND DURING INFUSION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10434553 ↗
• MalfunctionJul 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD A GROSHONG CATHETER IMPLANTED ON (B)(6) 2020. LEAKAGE WAS FOUND AT THE PART OF THE CATHETER OUT SIDE OF THE PATIENT WHEN FLUSHING ON THE FOLLOWING DAY. IT WAS FURTHER REPORTED THAT ANOTHER RUMEN HAS BEEN USED FOR INFUSION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314954 ↗
• MalfunctionJun 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CHEMOTHERAPY WAS STARTED BY PLACING THE GROSHON CATHETER ON (B)(6) 2020. THE LEAKAGE WAS FOUND NEAR THE SUTURE WING AND THERE WAS A CRACK AT CONNECTION PART OF THE CATHETER, DURING BLINATUMOMAB INFUSION ON (B)(6) 2020. IT WAS FURTHER REPORTED THAT THERE WAS NO EXTERNAL FORCE ON THIS CONNECTION PART. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10195828 ↗
• MalfunctionApr 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE GROSHONG CATHETER WAS ALLEGEDLY RUPTURED UPON LOCKING CATHETER WITH SALINE. IT WAS FURTHER REPORTED THAT DAMAGE WAS FOUND AT THE PART SECURED BY TAPE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009728 ↗
• MalfunctionFeb 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9756669 ↗
• MalfunctionFeb 12, 2020Material Deformation; Material Deformation

  DURING DEVICE EVALUATION, IT WAS DETERMINED THAT THERE WAS A MATERIAL "FLAW" ON THE CATHETER SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9701596 ↗
• MalfunctionJan 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CRACK WAS FOUND ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9548177 ↗
• MalfunctionJan 3, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER BREAKAGE WAS FOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9548158 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED THAT THE CATHETER PART WHICH WAS OUTSIDE OF THE PATIENT BODY WAS BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9372352 ↗
• MalfunctionNov 14, 2019Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE EXTENSION TUBE OF THE GROSHONG CATHETER, WHICH WAS IMPLANTED IN THE PATIENT WITH DELIRIUM, BALLOONED DURING FLUSHING. AFTER THAT, THE PATIENT PULLED THE EXTENSION TUBE AND TORE OFF IT. THE MEDICAL INSTITUTION IS REQUESTING TO INVESTIGATE THE CAUSE OF THE BALLOONED EXTENSION TUBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9323749 ↗
• MalfunctionOct 24, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY THE PATIENT THAT APPROX 1 MONTH AGO RED PORT OF PICC CAME APART AT RED AND WHITE CONNECTION SITE, REINSERTED AND CONTINUED TO BE USED. ON MONDAY SEP 30, 2019 WRITER INSPECTED PICC AND WAS ABLE TO DISCONNECT EASILY RED PORT. PICC REMOVED AND NEW PICC INSERTED. NOTE THAT LIMITED INFORMATION WAS AVAILABLE AS IT WAS A REPORT BY THE PATIENT WHO CAME FROM HOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234643 ↗
• MalfunctionSep 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. 08/29/2019 ADDITIONAL INFORMATION WAS RECEIVED FROM THE FACILITY. IT WAS ADDITIONALLY REPORTED THAT BECAUSE THE PATIENT COMPLAINED OF LEAKAGE DURING CONTINUOUS ADMINISTRATION OF AN ANTICANCER AGENT, THE CATHETER WAS CHECKED AND LEAKAGE WAS FOUND NEAR THE INSERTION SITE. THEREFORE, THE DRESSING WAS CHANGED; HOWEVER, LEAKAGE WAS FOUND NEAR THE INSERTION SITE AGAIN. THEREFORE, THE CATHETER WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9035876 ↗
• MalfunctionJun 21, 2019Crack; Fluid/Blood Leak; Obstruction of Flow

  IT WAS REPORTED THAT THE LEAKAGE WAS FOUND FROM THE CATHETER CRACK WHICH WAS APPROXIMATELY 43CM FROM DISTAL TIP OF THE CATHETER. THE MEDICAL INSTITUTION GUESSED THAT OCCLUSION OF THE LUMEN ON THE WHITE HUB SIDE MAY HAVE AFFECTED REPORTED CATHETER DAMAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724591 ↗
• MalfunctionMay 2, 2019Infusion or Flow Problem

  IT WAS REPORTED THAT JUST AFTER PLACEMENT OF THE GROSHONG CATHETER, MEDICAL SOLUTION COULD NOT BE INFUSED. THEREFORE, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8575768 ↗
• MalfunctionApr 25, 2019Material Deformation

  IT WAS REPORTED THAT WHEN THE LUMEN OF THE WHITE HUB SIDE WAS FLUSHED, THE CATHETER WAS INFLATED LIKE A BALLOON NEAR THE BIFURCATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8552280 ↗
• MalfunctionApr 11, 2019Fracture

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED ON (B)(6) 2019. WHEN THE REMOVED CATHETER WAS CONFIRMED, THE MATERIAL WAS WEAKER THAN THE USUAL CATHETER, AND IT WAS EASILY FRACTURED BY PULLING A LITTLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8505002 ↗