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CARDINAL HEALTH SANHFCLWHERecalls & reported problems

Cardinal Health 200, LLC · STEWARD ROCKLEDGE CATH RRS PK · Class 2

Data updated Oct 18, 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 10888439643848), received between Oct 28, 2020 and Oct 28, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (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.

Most reported problems

Device problems

  • Degraded2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionOct 28, 2020Degraded

    THE CUSTOMER REPORTED NOTICING VISIBLE LINT ON THE TOWELS A COUPLE OF WEEKS AGO. THE LINT HAS GOTTEN ON DEVICES, GLOVES, DRAPES - ANYTHING THE TOWELS TOUCH. NO PATIENT DEMOGRAPHICS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10748416 ↗
  • MalfunctionOct 28, 2020Degraded

    BASED ON INFORMATION RECEIVED FROM THE CUSTOMER REPORTEDLY THERE IS LINT ON TOWELS PWTB04-STM. ALLEGEDLY IT HAS GOTTEN ON DEVICES, GLOVES, DRAPES, ANYTHING THE TOWELS TOUCH. PER THE CUSTOMER, THERE WAS NO INJURY AND NO PATIENT AFFECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10747317 ↗

Other Angiography/angioplasty kit devices

All Angiography/angioplasty kit devices →

Sources and updates

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