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PowerHickman 0802915Recalls & reported problems

Bard Access Systems, Inc. · PowerHickman 9.5F Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff (2cm) Microintroducer Kit · Class 2 · Implant

All models of PowerHickman (6)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741036651), received between Oct 26, 2020 and Apr 13, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (1 report).

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

  • Defective Component1
  • Difficult or Delayed Separation1
  • Loss of or Failure to Bond1
  • Material Separation1
  • Separation Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 13, 2021Loss of or Failure to Bond; Defective Component; Loss of or Failure to Bond; Defective Component

    IT WAS REPORTED THAT DURING PREPARATION OF AN CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FOUND DEFECTIVE AND CUFF LOCATED AT 0 CM INSTEAD OF 2 CM. IT WAS FURTHER REPORTED THAT CATHETER WAS NOT IMPLANTED BECAUSE OF DEFECTIVE CUFF LOCATION. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11656051 ↗
  • MalfunctionOct 26, 2020Material Separation; Separation Failure; Difficult or Delayed Separation; Material Separation; Separation Failure; Difficult or Delayed Separation

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0802915 CHRONIC CATHETERS ALLEGEDLY EXPERIENCED DIFFICULT OR DELAYED SEPARATION, MATERIAL SEPARATION AND SEPARATION FAILURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. AGE, GENDER AND WEIGHT WERE NOT PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10738095 ↗

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Sources and updates

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