Hickman 0600574Recalls & reported problems
Bard Access Systems, Inc. · Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff · Class 2 · Implant
All models of Hickman (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741051876), received between Feb 24, 2017 and Dec 24, 2024 — classified as 3 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (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.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device2
- Fracture2
- Device Dislodged or Dislocated1
- Failure to Infuse1
- Hole In Material1
- Material Integrity Problem1
- Material Puncture/Hole1
- Suction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Air Embolism1
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 24, 2024Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT SOMETIMES POST A CHRONIC CATHETER PLACEMENT, THE OUTER SHEATH OF CATHETER WAS ALLEGEDLY DAMAGED AT BIFURCATION SITE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21009838 ↗InjuryDec 24, 2024Suction Problem; Suction Problem
IT WAS REPORTED THAT SOMETIMES POST A CHRONIC CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD NO BLOOD RETURN. IT WAS ALSO FURTHER REPORTED THAT THE PATIENT HAD AN INFECTION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 21009655 ↗InjuryMay 25, 2022Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR, THE PATIENT ALLEGEDLY EXPERIENCED AIR EMBOLISM. IT WAS FURTHER REPORTED THAT MEDICAL INTERVENTIONS WAS REQUIRED TO REMOVE AIR EMBOLISM THROUGH MEDICATIONS. THE PATIENT REPORTEDLY TO BE STABLE.
Patient problems: Air Embolism
MAUDE report 14496965 ↗MalfunctionMay 25, 2022Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR, THE DEVICE ALLEGEDLY HAD BUBBLES IN THE LINE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14495838 ↗MalfunctionOct 5, 2021Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole
IT WAS REPORTED THAT PRIOR TO A CHRONIC CATHETER PLACEMENT PROCEDURE, A HOLE WAS ALLEGEDLY FOUND NEAR THE DISTAL END OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12576378 ↗MalfunctionJun 17, 2019Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST CATHETER PLACEMENT, THE WHITE LUMEN ALLEGEDLY FAILED TO FLUSH. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8704478 ↗InjuryApr 14, 2017Device Dislodged or Dislocated
IT WAS REPORTED BY THE SALES REP THAT THE PATIENT HAD A HICKMAN CATHETER PLACED ON (B)(6) 2016. IN (B)(6) OF 2017, A FULL SEGMENT REPAIR WAS COMPLETED. TWO WEEKS LATER THE FACILITY TRIED TO ACCESS THE CATHETER AND IT WAS "SLUGGISH" SO THEY RAN CONTRAST WITH A 10 ML SYRINGE USING 3 ML OF CONTRAST AND ON THE THIRD TIME FLUORO NOTICED THE METAL STRUT HAD FLOATED DOWN THE CATHETER AND EXITED INTO THE PATIENT, LODGING IN HIS PULMONARY ARTERY BRANCH. THE SALES REP STATED THAT THE PATIENT IS STABLE AND THE FACILITY DID NOT TRY TO REMOVE IT. THE SALES REP STATED IT WAS THE ARTERIAL METAL STRUT THAT BROKE OFF. PATIENT REMAINS ASYMPTOMATIC. FACILITY REPORTED THAT CATHETER WAS REMOVED AND REPLACED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6494818 ↗MalfunctionFeb 24, 2017Hole In Material
FACILITY REPORTED THAT THE WHITE LUMEN HAD A PINHOLE AT HUB OF LINE. FACILITY ALSO REPORTED THAT THE OUTER LAYER HAD SEPARATED ABOVE THE TRIANGLE AREA WHERE THE LUMENS MEET. REQUIRED DUAL REPAIR. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6356844 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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