Hickman 0600604Recalls & reported problems
Bard Access Systems, Inc. · Hickman 9 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741051906), received between Feb 3, 2017 and Mar 8, 2021 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
Device problems
- Fracture4
- Fluid/Blood Leak2
- Air Leak1
- Break1
- Crack1
- Hole In Material1
- Material Rupture1
- Noise, Audible1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Chemical Exposure1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2021Fracture; Fracture
IT WAS REPORTED SOME DAY POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT, THE DEVICE WAS REMOVED ON LATER DAYS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11434900 ↗MalfunctionMar 8, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE DEVICE ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT, THE DEVICE ALLEGEDLY LEAKED FLUIDS. REPORTEDLY, THE DEVICE WAS REMOVED ON LATER DAYS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11430860 ↗MalfunctionMar 3, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT POST DEVICE IMPLANT ON THE LEFT SUBCLAVIAN, THE CATHETER WAS ALLEGEDLY FOUND TO HAVE RUPTURED. IT WAS FURTHER REPORTED THAT LEAKAGE OF FLUIDS WAS NOTED. THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11402856 ↗MalfunctionMar 3, 2021Fracture; Fracture
IT WAS REPORTED THAT SOMETIME POST DEVICE IMPLANT ON THE LEFT SUBCLAVIAN, THE CATHETER WAS ALLEGEDLY NOTED TO HAVE RUPTURED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11402855 ↗MalfunctionApr 10, 2020Break; Break
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600604 CHRONIC CATHETER ALLEGEDLY EXPERIENCED BREAK. THIS INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES. THIS MALFUNCTION INVOLVED BOTH PATIENTS WITH NO CONSEQUENCES. BOTH (B)(6) MALE PATIENTS WEIGHT WAS (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9950835 ↗MalfunctionDec 6, 2017Air Leak; Hole In Material; Noise, Audible
IT WAS REPORTED BY THE FACILITY THAT THEY WERE ABLE TO GET BLOOD RETURN, BUT WERE UNABLE TO FLUSH THE CATHETER TO CLEAR THE REMNANT BLOOD. THE NURSE HEARD A POP AND WAS UNABLE TO GET BLOOD AFTER SHE HEARD THE POP. AIR BUBBLES WERE NOTED UPON WITHDRAWAL. CHARGE NURSE WAS NOTIFIED AND ACCESSED CATHETER. NURSE FOUND A SMALL TEAR LIKE HOLE JUST DISTAL TO THE PLASTIC TRIANGULAR JUNCTURE IN THE CATHETER. THE CATHETER WAS REMOVED AND PHYSICIAN WAS NOTIFIED, NEW PICC PLACED AND CONFIRMED TIP LOCATION VIA X-RAY. NO REPORTED PATIENT INJURY.
Patient problems: No Code Available
MAUDE report 7087949 ↗MalfunctionMay 22, 2017Crack
PER MEDWATCH, THE FACILITY REPORTED THAT A HOME NURSE WAS FLUSHING THE HICKMAN AND THE CATHETER CRACKED. IT WAS STATED THAT THE PATIENT WAS TAKEN INTO IR FOR REMOVAL OF THE CATHETER AND A NEW ONE WAS PLACED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6583450 ↗MalfunctionFeb 3, 2017Material Rupture
PER SALES REPRESENTATIVE, THE FACILITY REPORTED THAT THEY WENT TO DRAW BLOOD FOR MORNING LABS ON A PATIENT FROM A (B)(6). THEY WERE ABLE TO FLUSH THE FIRST PORT WITHOUT DIFFICULTY AND DREW SPECIMENS. THEY PREPARED THE SECOND PORT TO FLUSH AND FELT NO RESISTANCE WITH THE INITIAL PUSH AND CONTINUED. SALINE THEN SPRAYED OUT ONTO THE PATIENT¿S FACE. FACILITY NOTED A RUPTURE IN THE CATHETER PROXIMAL TO PHALANGE PRIOR TO WHERE THE PORTS BIFURCATE. THE LINE WAS CLAMPED WITH HEMOSTATS, TAPED TO THE CHEST SECURELY AND THE DOCTOR NOTIFIED. THE CATHETER WAS REPLACED. FACILITY REPORTED THAT IT¿S POSSIBLE THAT THE CLAMP WAS POSITIONED TOO LOW BY THE NURSE ON THIS PATIENT¿S LINE. NO PATIENT INJURY REPORTED.
Patient problems: Chemical Exposure
MAUDE report 6301293 ↗
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- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
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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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