NA SHEATH1.4Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00858778006003), received between Feb 3, 2020 and Sep 15, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Difficult or Delayed Separation

  It was reported when you peel the banana, one side doesn't peel off all the way and gets stuck on the catheter. This time it broke off on the bottom. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775484 ↗
• MalfunctionSep 15, 2026Difficult or Delayed Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775482 ↗
• MalfunctionSep 2, 2026Difficult or Delayed Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572803 ↗
• MalfunctionSep 2, 2026Difficult or Delayed Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569330 ↗
• MalfunctionSep 2, 2026Misassembled

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567720 ↗
• MalfunctionMay 13, 2020Break; Difficult to Remove; Physical Resistance/Sticking

  1.4 FRENCH FOOTPRINT PICC PLACED USING INTRODUCER. LINE WAS INSERTED, WHEN THE INTRODUCER WAS BROKEN TO BE REMOVED FROM THE LINE, ONLY ONE HALF OF THE INTRODUCER CAME OFF OF THE LINE. THE REMAINING HALF OF THE INTRODUCER BECAME STUCK AND WAS UNABLE TO BE REMOVED FROM THE PICC ITSELF AND COULD BE SLID EASILY UP AND DOWN THE LINE. ANOTHER PROVIDER WAS CALLED TO THE BEDSIDE, WHERE SHE USED THE FORCEPS TO PICK AT THE PLASTIC OF THE INTRODUCER TO LOOSEN IT AND ULTIMATELY WAS ABLE TO REMOVE IT FROM THE PICC LINE. LOT # 191518; 1.4FR PICC INTRODUCER; FOOTPRINT BRAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10051206 ↗
• MalfunctionFeb 3, 2020Difficult to Remove; Material Separation

  A NURSE PRACTITIONER INSERTED CENTRAL 1.4 FR, 26 GAUGE POLYURETHANE FOOTPRINT PICC LINE INTO LEFT ARM OF INFANT PATIENT AT 1 WEEK OF LIFE, 28 AND 1/7 WEEKS GESTATION FOR LONGER TERM TPN/INTRALIPID THERAPY AS HIS FEEDINGS ARE RE-STARTED AND SLOWLY ADVANCED. PICC LINE WAS INSERTED INTO INFANT'S LEFT ARM BASILIC VEIN WITHOUT INCIDENT. UPON WITHDRAWAL OF INTRODUCER NEEDLE, NP THEN WENT TO REMOVE THE INTRODUCER NEEDLE SHEATH. UPON ATTEMPT TO REMOVE SHEATH, ONLY ONE HALF OF THE END OF THE BREAKAWAY SHEATH CAME OFF INSTEAD OF BOTH ENDS AND THE ENTIRE SHEATH PEELING OFF. ATTEMPT WAS MADE TO REMOVE THE REMAINDER OF THE SHEATH COVERING THE CATHETER ITSELF WITHOUT SUCCESS. PHYSICIAN WAS CONSULTED AND DECISION MADE TO REMOVE THE VERY END OF THE OTHER HALF OF THE BREAKAWAY SHEATH AND LEAVE THE 2 CM SHEATH OVER THE VERY END OF THE LINE NEAR THE HUB. PICC LINE IS CENTRAL IN LOCATION AND FUNCTIONING WELL WITH GOOD BLOOD RETURN AND ABILITY TO EASILY FLUSH CATHETER. 2 DAYS LATER, ANOTHER NP WAS ABLE TO CAREFULLY REMOVE THE SHEATH OVER THE CATHETER WITHOUT INCIDENT. LINE REMAINS INTACT AND CONTINUES TO FUNCTION WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9659302 ↗