Groshong NXT Catheter 9957505Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741036248), received between Mar 30, 2016 and Jun 21, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2017Fracture

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT'S NURSE HAD WITHDRAWN BLOOD FROM CVC FOR SPECIMEN COLLECTION. SYRINGE METHOD WAS USED FOR BLOOD COLLECTION. AS THE NURSE ATTEMPTED TO FLUSH THE PICC WITH NORMAL SALINE, SHE STATED SHE SAW A SPLASH OF FLUID FROM THE LINE. UPON INSPECTION, SHE NOTED THAT ONE OF THE LUMENS OF THE PICC LINE HAD FRACTURED AND THERE WAS A CRACK IN IT. SHE CLAMPED THE LINE AND NOTIFIED THE AVAS TEAM. THE PICC LINE HAD TO BE REMOVED FROM THE PATIENT. THE PATIENT REQUIRED A NEW INSERTION.

  Patient problems: Venipuncture

  MAUDE report 6656710 ↗
• MalfunctionSep 22, 2016Hole In Material; Leak/Splash

  IT WAS REPORTED THAT THE NURSING STAFF ASSESSED PICC AND PATIENT COMPLAINED OF A COOL SENSATION UNDER SKIN WHICH HAD NOT BEEN FELT PREVIOUSLY. PICC HAD PREVIOUSLY BEEN ASSESSED FOR A SLUGGISH LINE. PICC WAS REPORTEDLY LEAKING AND HAD TO BE REMOVED AS THE LINE COULD NOT BE REPAIRED. ONCE THE CATHETER WAS REMOVED, IT WAS NOTED THAT THERE WAS A PIN HOLE AT 47 CM. SECUREACATH WAS CLOSE TO PIN HOLE AT 48 CM.

  Patient problems: Foreign Body Sensation in Eye

  MAUDE report 5971426 ↗
• MalfunctionMay 12, 2016Leak/Splash

  IT WAS REPORTED THAT ONCE THE PICC WAS REMOVED, A LEAK AT THE 55CM MARK IN THE BLUE PORTION OF THE LINE JUST BELOW THE WHITE WINGS WAS OBSERVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5650615 ↗
• MalfunctionApr 28, 2016Fracture

  IT WAS REPORTED THAT AFTER PICC WAS INSERTED IN THE PATIENT, X-RAYS SHOWED THAT THE PICC NEEDED TO BE ADJUSTED AS PER RADIOLOGIST RECOMMENDATION. WHEN REMOVING THE SECURACATH, PICC WAS REPORTEDLY FRACTURED AND A REPLACEMENT PICC HAD TO BE INSERTED. ON (B)(6) 2016 - RETURNED SAMPLE SHOWS EVIDENCE OF A SUBCUTANEOUS CATHETER BREAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5617000 ↗
• MalfunctionMar 30, 2016Hole In Material; Leak/Splash

  IT WAS REPORTED THAT A PICC WAS LEAKING FROM THE RED LUMEN. THE PICC WAS REMOVED AND THE FACILITY STATED THAT A PINHOLE WAS NOTED AT 41 CM. THE INSERTED LENGTH WAS 42 CM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5536930 ↗