McKesson 16-SLFOL516Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10612479245850), received between Jun 9, 2025 and Jul 27, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Difficult to Remove

  It was reported by the customer the balloon not deflating, They are having to pop the balloon inside the patient and remove it. At least 3 patients needed ER assistance for removal and one of those patients required surgery.

  Patient problems: Foreign Body In Patient

  MAUDE report 50007683 ↗
• InjuryApr 28, 2026Obstruction of Flow

  IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER BECAME CLOGGED IN THE PATIENT. PATIENT WAS SENT TO THE ER WHERE BLOOD PRESSURE WAS REPORTED TO BE OVER 300 MM HG.

  Patient problems: Urinary Retention

  MAUDE report 25015228 ↗
• MalfunctionJun 9, 2025Defective Component; Failure to Deflate

  16F FOLEY CATHETER BALLOON MALFUNCTIONED. BALLOON DID NOT DRAIN WHEN IT WAS TIME TO DISCONTINUE THE FOLEY AFTER BLADDER INSTILLATION. URINE DRAINED APPROPRIATELY THROUGHOUT PATIENTS TREATMENT. 10CC WAS USED TO FILL BALLOON. ATTEMPTED TO USE MULTIPLE EMPTY SYRINGES TO DEFLATE BALLOON ON THE CATHETER VALVE. BALLOON DID NOT DEFLATE ON ITS OWN. COULD NOT MANUALLY ASPIRATE THE BALLOON. THE Y TIP WAS CUT IN ORDER FOR THE BALLOON TO DEFLATE THUS POSSIBLY EXPOSING PATIENT / NURSES / ENVIRONMENT TO CHEMO.

  Patient problems: Contamination, chemical

  MAUDE report 22165947 ↗