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CARDINAL HEALTH SAN23HVRHARecalls & reported problems

Cardinal Health 200, LLC · STRL HEART AND VASCULAR UNIV · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488400150), received between Aug 3, 2018 and Aug 3, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Disintegration” (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 18, 2026.

Most reported problems

Device problems

  • Material Disintegration1

Patient problems

  • Foreign Body In Patient1
  • Loss of consciousness1
  • Low Blood Pressure/ Hypotension1

Recent adverse event reports

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

  • InjuryAug 3, 2018Material Disintegration

    THE BLUE TOWELS PWTB03-STMA WAS LINTING WITHIN PACK SAN23HVRHA. THE LINT WAS FOUND ON THE TOWELS, STERILE GLOVES OF THE SURGEON AND ON AN INTERVENTIONAL WIRE DURING A CARDIAC CAROTID IABP INSERTION. THE TOWELS ARE USED TO DRY HANDS AND ABSORB LIQUID (WATER, BLOOD) ON THE PROCEDURE TABLE AND SCRUB TABLE. THE PATIENT BECAME UNRESPONSIVE DURING THE PROCEDURE, BLOOD PRESSURE DECREASED AND PATIENT WAS INTUBATED SO THE CUSTOMER FELT THE LINTING COULD HAVE CONTRIBUTED TO THIS.

    Patient problems: Foreign Body In Patient; Loss of consciousness; Low Blood Pressure/ Hypotension

    MAUDE report 7748129 ↗

Other Cardiovascular procedure kit devices

All Cardiovascular procedure kit devices →

Sources and updates

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