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Hickman 0601740Recalls & reported problems

Bard Access Systems, Inc. · External Catheter Segment for Hickman 12.5F Triple Lumen CV Catheters Repair Kit · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741036460), received between Apr 3, 2023 and Apr 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jan 4, 2023Open, Classified

    Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

    Z-1051-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Coagulation in Device or Device Ingredient1
  • Nonstandard Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 3, 2023Coagulation in Device or Device Ingredient; Nonstandard Device; Coagulation in Device or Device Ingredient; Nonstandard Device

    IT WAS REPORTED THAT DURING THE PREPARATION OF PORT PLACEMENT, THE MEDICAL ADHESIVE GLUE WAS ALLEGEDLY ALREADY SET IN SEALED TUBE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16665493 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

All Catheter,intravascular,therapeutic,long-term greater than 30 days devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.