CARDINAL HEALTH SAN2ARAKPIRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439854916), received between Apr 27, 2021 and Apr 27, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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

Recent adverse event reports

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

• MalfunctionApr 27, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED THAT DURING A CEREBRAL PROCEDURE THERE WAS A LARGE AMOUNT OF LINT ON THE BLUE TOWELS PWTB04-STM FROM ANGIO PACK, SAN2ARAKPI. THE TOWELS WERE LAID ON THE PATIENT DRAPE TO ABSORB FLUID. LINT WAS FOUND ON INSTRUMENT WIRES. THERE WAS A 60 SECOND DELAY TO REMOVE THE LINT WITH NO PATIENT INJURY. NO CLINICAL DATA OR PATIENT DEMOGRAPHICS WERE PROVIDED AFTER NUMEROUS ATTEMPTS TO OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732944 ↗
• MalfunctionApr 27, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED THAT DURING A CARDIAC PROCEDURE THERE WAS A LARGE AMOUNT OF LINT ON THE BLUE TOWELS PWTB04-STM FROM ANGIO PACK, SAN2ARAKPI. THE TOWELS WERE LAID ON THE PATIENT DRAPE TO ABSORB FLUID. LINT WAS FOUND ON INSTRUMENT WIRES. THERE WAS A 60 SECOND DELAY TO REMOVE THE LINT WITH NO PATIENT INJURY. NO CLINICAL DATA OR PATIENT DEMOGRAPHICS WERE PROVIDED AFTER NUMEROUS ATTEMPTS TO OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732927 ↗