Catheter Repair Kit 5587000Recalls & reported problems
Bard Access Systems, Inc. · Catheter Repair Kit with Replacement Connector · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741045080), received between Jun 7, 2018 and Dec 15, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Component Misassembled1
- Device Markings/Labelling Problem1
- Failure to Infuse1
- Manufacturing, Packaging or Shipping Problem1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2025Fracture; Fracture
A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE GLIDEPATH DIALYSIS CATHETER. POST THE PROCEDURE, IT WAS NOTED THAT THE CLAMP WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23800070 ↗MalfunctionDec 15, 2025Fracture; Fracture
A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE GLIDEPATH DIALYSIS CATHETER. POST THE PROCEDURE, IT WAS NOTED THAT THE CLAMP WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23800069 ↗MalfunctionJun 6, 2025Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Packaging Problem; Component Misassembled; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Packaging Problem; Component Misassembled
A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING VASCATH ACCESSORIES. DURING THE PREPARATION OF THE PORT PLACEMENT PROCEDURE THE PRODUCT ALLEGEDLY FOUND DAMAGED. IT WAS FURTHER REPORTED THAT INCORRECT PACKAGING. REPORTEDLY, MATERIAL NOT IN ORIGINAL CASE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22159009 ↗MalfunctionJun 7, 2018Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY UNABLE TO RUN TREATMENT AFTER USE OF THE REPAIR KIT. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7580479 ↗
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- Palindrome 8888541128Mozarc Medical US LLC · Kit, repair, catheter, hemodialysis1 report
- Palindrome 8888541123Mozarc Medical US LLC · Kit, repair, catheter, hemodialysis1 report
- ARROW IPN920485Teleflex Incorporated · Kit, repair, catheter, hemodialysis1 report
- ARROW IPN033232Teleflex Incorporated · Kit, repair, catheter, hemodialysis1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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