Argyle 8888561019Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521029255), received between Jan 24, 2023 and Jan 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Disconnect” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJan 24, 2023Failure to Disconnect; Failure to Disconnect

  CUSTOMER REPORTS: AFTER INSERTING A 10FR TROCAR CHEST TUBE INTO THE INFANT'S CHEST, C. LOUGHRAN WAS UNABLE TO REMOVE THE STYLET/GUIDEWIRE PORTION FROM THE CHEST TUBE. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE TUBE BUT IT WAS NOT POSSIBLE. THE CHEST TUBE HAD TO BE REMOVED AND A NEW CHEST TUBE WAS INSERTED. INTERVENTION WAS REQUIRED FOR PLACEMENT OF THE NEW CHEST DUE TO THE EQUIPMENT MALFUNCTION OF THE ORIGINAL ONE. THE PATIENT WAS MONITORED THROUGHOUT THE PROCEDURE AND NO ACUTE CHANGES WERE NOTED BY THE PROVIDERS AND BEDSIDE STAFF. THE CHEST TUBE WAS PLACED IN A BIOHAZARD BAG AT THE BEDSIDE, IF NEEDED FOR FURTHER INVESTIGATION. PER ADDITIONAL INFORMATION RECEIVED ON 1/24/23, THE END OF THE DEVICE APPEARED TO BE TAPERED CORRECTLY AND THE WIRE INSERT ALSO APPEARED TO BE EMBEDDED CORRECTLY. THERE WAS NO PATIENT INJURY AND THE MEDICAL INTERVENTION REQUIRED WAS TO PULL AND REPLACE THE CHEST TUBE. THE PATIENT HAS NO ISSUES REGARDING THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237130 ↗