Bardex® Lubri-Sil® All-Silicone Foley Catheter 70516LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741034343), received between Jan 19, 2023 and Dec 7, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT QC HAS REJECTED FOLEY CATHETERS FOR PARTICULATE. CUSTOMER HAS JUST TRANSMITTED 4CS TO REPLACE THE INVENTORY. PER FOLLOW UP VIA PHONE ON (B)(6) 2023,IT WAS REPORTED THAT THE PARTICLES WERE DETECTED FREQUENTLY FROM INSIDE OF THE FOLEY CATHETERS ,ALSO THEY COULD NOT DETERMINE TYPE OF PARTICULATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282258 ↗
• MalfunctionOct 12, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER IDENTIFIED A QUALITY ISSUE WITH THE STOCK OF SILICONE FOLEY CATHETER, WHICH PREVENTS THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF THEIR KITS. IT WAS FOUND THAT THERE WERE PARTICLES. PER FOLLOW UP VIA EMAIL ON 05OCT2023, IT WAS REPORTED THAT THE PARTICLES WERE DETECTED INSIDE THE CATHETER AND ON DIFFERENT SIDES OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919646 ↗
• MalfunctionJan 19, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER IDENTIFIED QUALITY ISSUE WITH THE MEDLINE ITEM NUMBER 81145 AND FOLEY CATHETER 70516L WHICH PREVENTED THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF KITS. IT WAS FOUND THAT THERE WERE PARTICULATES INSIDE THE COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16205581 ↗