CARDINAL HEALTH SCV73OHDSCRecalls & reported problems
Cardinal Health 200, LLC · HEART 2 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885425802176), received between Sep 25, 2020 and Sep 25, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Material Fragmentation1
- Material Frayed1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2020Material Fragmentation
CUSTOMER REPORTED LINTING OF THE OR COTTON TOWELS PWTB04-STM FROM THE HEART PACK SCV73OHDSC. THE SURGEON STATED THAT THE LINTING WAS SO BAD THAT HE IS CONCERNED THAT IT SHOULD BE DOCUMENTED AS A RETAINED FOREIGN BODY AND NOW THEY ARE REMOVING FROM ALL KITS PRIOR TO A PROCEDURE. NO PATIENT DEMOGRAPHICS OR ANY CLINICAL DATA WAS PROVIDED UPON REQUEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10590308 ↗MalfunctionSep 25, 2020Material Frayed
CUSTOMER REPORTED FRAYING OF THE X-RAY GAUZE C-NXR4416A FROM THE HEART PACK SCV73OHDSC. THE SURGEON STATED THAT THE FRAYING OF LINT WAS SO BAD THAT HE IS CONCERNED THAT IT SHOULD BE DOCUMENTED AS A RETAINED FOREIGN BODY AND NOW THEY ARE REMOVING FROM ALL KITS PRIOR TO A PROCEDURE. NO PATIENT DEMOGRAPHICS OR ANY CLINICAL DATA WAS PROVIDED UPON REQUEST.
Patient problems: Foreign Body In Patient
MAUDE report 10590183 ↗MalfunctionSep 25, 2020Device Contamination with Chemical or Other Material
CUSTOMER REPORTED LINTING OF THE LAP SPONGES LS1818PSA FROM THE HEART PACK SCV73OHDSC. THE SURGEON STATED THAT THE LINTING WAS SO BAD THAT HE IS CONCERNED THAT IT SHOULD BE DOCUMENTED AS A RETAINED FOREIGN BODY AND NOW THEY ARE REMOVING FROM ALL KITS PRIOR TO A PROCEDURE. NO PATIENT DEMOGRAPHICS OR FURTHER CLINICAL DATA WAS PROVIDED UPON REQUEST.
Patient problems: Insufficient Information
MAUDE report 10589970 ↗
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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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