Leonard 0600634Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741051968), received between Mar 23, 2017 and Sep 2, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2021Fracture; Fracture

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY TEN DAYS POST CATHETER PLACEMENT, THE PATIENT DEVELOPED ADVERSE EVENT OF TORN CATHETER LUMEN DURING REGULAR FLUSHING. THE CATHETER WAS REMOVED AND EXCHANGED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414868 ↗
• MalfunctionNov 16, 2018Suction Problem; Suction Problem

  IT WAS REPORTED THAT THE HEALTH CARE PROVIDER WAS UNABLE TO ASPIRATE. IT WAS FURTHER REPORTED THAT A CT EXAM WAS PERFORMED AND ALLEGEDLY THE CATHETER WAS OCCLUDED. REPORTEDLY, THE DEVICE WAS REMOVED AND A NEW DEVICE PLACED. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8081945 ↗
• MalfunctionAug 22, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT UPON OPENING THE DEVICE PACKAGING, IT WAS NOTED THAT THE CATHETER WAS CRACKED AT THE HUB. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7807283 ↗
• MalfunctionJan 10, 2018Material Rupture; Improper or Incorrect Procedure or Method; Material Deformation

  PER MS&S, THE PATIENT'S HUSBAND STATED HIS WIFE HAD A LEONARD CATHETER INSERTED LAST SPRING FOR TPN AND LIPIDS. HE SAID THAT BOTH LUMENS HAVE BEEN WORKING WELL UNTIL TWO DAYS AGO WHEN THE WHITE LUMEN BECAME SLUGGISH. THE HUSBAND RECALLED THAT THEY WERE NOT TAUGHT TO ASPIRATE AND CHECK BLOOD RETURN PRIOR TO THE START OF THE TPN OR LIPIDS. ON (B)(6) 2017: THE HUSBAND REPORTED THAT, "THE DOCTORS FOUND A CRIMP IN THE LINE WHERE IT ENTERS THE SKIN, AND CONSEQUENTLY A SMALL RUPTURE IN THE SLUGGISH LUMEN.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7179595 ↗
• MalfunctionJun 22, 2017Device Operates Differently Than Expected

  PER MEDICAL SERVICES AND SUPPORT (MS&S) THE PATIENT STATED THE CATHETER WAS PLACED (B)(6) 2017. SHE REPORTED THAT THE WHITE LUMEN BALLOONED OUT NEAR THE V OF THE CATHETER. SHE STATED THE RED LUMEN WORKS WELL AND SHE JUST BEEN USING THE RED LUMEN. THE PATIENT EXPRESSED THAT THE PHYSICIANS DID NOT WANT TO REPAIR THE CATHETER. SHE STATED THEY FEEL LIKE THE REPAIR IS NOT A FIX TO THE BALLOONING OF THE CATHETER. MS&S ADVISED THE PATIENT TO CONTACT HER PHYSICIAN TO HAVE THE CATHETER EVALUATED FOR POSSIBLE REPAIR, INFORMED THE WHITE LUMEN SHOULD NOT BE BALLOONING OUT WHEN FLUSHED. INFORMED THE PATIENT THAT THE HICKMAN WHITE LEG REPAIR KIT AND THE BODY SEGMENT REPAIR KIT THAT WOULD GIVE 2 NEW ENDS WOULD BE OPTIONS FOR REPAIR. MS&S INFORMED THAT THE CATHETER IS CONSIDERED REPAIRED ONCE REPAIRED AS INTENDED IN THE INSTRUCTIONS FOR USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6659821 ↗
• MalfunctionJun 6, 2017Material Fragmentation

  IT WAS REPORTED BY THE FACILITY VIA MEDWATCH THAT THE PATIENT HAD A HICKMAN CATHETER PLACED IN THE RIGHT UPPER CHEST PER VASCULAR SURGERY IN 2017. IT WAS STATED THAT WHEN FLUSHING THE RED CAPPED LUMEN WITH 10 ML STERILE NS FLUSH, AFTER UNCLAMPING THE CLAMP, THE LINE BLEW, TEARING OPEN.

  Patient problems: No Information

  MAUDE report 6616803 ↗
• MalfunctionMar 23, 2017Hole In Material

  IT WAS REPORTED BY THE FACILITY THAT THE NURSE WENT TO FLUSH THE RED CAPPED PORT OF THE GROSHONG CATHETER AND THERE WAS AN ALLEGED HOLE IN THE CATHETER JUST BELOW THE LARGER PART OF THE LUMEN OF THE PIGTAIL. THE PATIENT REQUIRED INTERVENTIONAL RADIOLOGY TO REPLACE THE GROSHONG CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6430290 ↗
• MalfunctionMar 23, 2017Fluid/Blood Leak; Torn Material

  IT WAS REPORTED BY THE FACILITY THAT THE NURSE WENT TO FLUSH THE GROSHONG CATHETER AND BLOODY FLUID STARTED TO "SPURT" OUT OF THE PIGTAIL. THE NURSE INSPECTED THE CATHETER AND ALLEGED A 1/4 INCH "SLIT" IN THE PIGTAIL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6430180 ↗