L-Cath™ D/L PICC 18GA (3.5F) 1.20 mm x 60 cmRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00886333209866), received between Apr 28, 2020 and Jul 12, 2023 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Crack” (17 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2023Crack; Crack

  CALLED TO BEDSIDE BY RN WHO REPORTED FLUIDS LEAKING FROM PICC. UPON ASSESSMENT, LIPIDS LEAKING AT MICROCLAVE CONNECTION. CONNECTION APPEARED LOOSE, UPON TIGHTENING, BLOOD BEGAN TO BACK UP INTO LUMEN. OF NOTE, CAP CHANGE PERFORMED PREVIOUS DAY ON THIS RED LUMEN AND T-CONNECTOR APPLIED DUE TO HISTORY OF THIS TYPE OF PICC LINES CRACKING, HOWEVER, T-CONNECTOR HAD BEEN APPLIED WITH MICROCLAVE ATTACHED TO PICC LINE. MICROCLAVE REMOVED UNDER STERILE CONDITIONS AND NEW T-CONNECTOR APPLIED. CRACK CONFIRMED, LINE CLAMPED AND FLUIDS D/C'D FROM LINE. FLC NOTIFIED, US GUIDED PIV PLACED.

  Patient problems: Insufficient Information

  MAUDE report 17306709 ↗
• MalfunctionJul 12, 2023Crack; Crack

  ON (B)(6) NIGHT SHIFT, BEDSIDE RN NOTICED THAT RED LUMEN ON PICC (3.5 FR LEFT FEMORAL) WAS LEAKING. VAS CAME TO ASSES AND NOTED IT TO BE CRACKED. LINE CLAMPED AND LINE LABELED DO NOT FLUSH. LINE REWIRED ON (B)(6), T-CONNECTOR CHANGED VAS CONSULTED AFTER TIER 0 REGARDING RED LUMEN MISSING T CONNECTOR. T CONNECTOR ADDED VIA ASEPTIC TECHNIQUE. BRISK BLOOD RETURN, FLUSHES EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306620 ↗
• MalfunctionAug 18, 2022Crack; Fluid/Blood Leak

  REMOVED DUE TO CRACKED LEAKING. PICC PLACED (B)(6) 2022. PICC REMOVED (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15251567 ↗
• MalfunctionJun 20, 2022Crack; Fluid/Blood Leak

  ¿BLUE LUMEN CRACKED LEAKING FLUIDS, A NEW LINE HAD TO BE PLACED DUE TO PATIENT NEEDS.¿ AFFECT ON PATIENT-¿TEMPORARY HARM, EVENT OCCURRED WHILE IN USE WITH PATIENT.¿

  Patient problems: Insufficient Information

  MAUDE report 14745081 ↗
• MalfunctionJun 20, 2022Crack; Leak/Splash

  SKU# 384467/LOT# 1402259. EVENT DESCRIPTION ¿¿DURING SAFETY CHECK RN NOTED WETNESS AT PICC SITE. RN ATTEMPTED LINE AND NAD CHANGE TO SEE IF LEAKING WOULD STOP. LEAKING CONTINUED PICC TEAM NOTIFIED RN FLUSHED AND CLAMPED PICC LINE AND NOTED CRACK IN BOTH LUMENS. PGE DRIP TRANSITIONED TO PIV AND PICC REMOVED. PICC LINE SAVED. NEW PICC LINE PLACED. BLUE ICU MEDICAL INC CLAVE NEUTRAL CONNECTOR ATTACHED TO BOTH LUMENS WHEN LEAK FOUND.¿

  Patient problems: Insufficient Information

  MAUDE report 14744954 ↗
• MalfunctionJun 20, 2022Crack; Leak/Splash

  DURING SAFETY CHECK RN NOTED WETNESS AT PICC SITE. RN ATTEMPTED LINE AND NAD CHANGE TO SEE IF LEAKING WOULD STOP. LEAKING CONTINUED PICC TEAM NOTIFIED RN FLUSHED AND CLAMPED PICC LINE AND NOTED CRACK IN BOTH LUMENS. PGE DRIP TRANSITIONED TO PIV AND PICC REMOVED. PICC LINE SAVED. NEW PICC LINE PLACED. BLUE ICU MEDICAL INC. CLAVE NEUTRAL CONNECTOR ATTACHED TO BOTH LUMENS WHEN LEAK FOUND. AFFECT ON PATIENT: NO HARM TO PATIENT, EVENT OCCUR WHILE IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744800 ↗
• MalfunctionApr 14, 2022Fluid/Blood Leak; Material Puncture/Hole

  CLINICIAN NOTICED LEAKING AND DISCOVERED A HOLE IN THE LINE BELOW HUB.

  Patient problems: Insufficient Information

  MAUDE report 14116644 ↗
• MalfunctionJan 24, 2022Fluid/Blood Leak; Migration or Expulsion of Device; Defective Device

  DEFECT IN BLUE LUMEN OF DOUBLE LUMEN PICC LED TO INFUSION ISSUES AND LEAKING. TUBING APPEARS TO BE MIGRATING AWAY FROM THE CAP. PHOTO AVAILABLE. THE PICC WAS REMOVED FROM PATIENT DUE TO DEFECT AND BLOODSTREAM INFECTION. PATIENT STARTED ON IV ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 13333771 ↗
• MalfunctionOct 9, 2020Crack

  ITEM #384467/LOT# 1128391 WAS INSERTED ON (B)(6) 2020. ON THE 53RD DAY OF DWELL THE HUB EXPERIENCED A LITTLE CRACK THEN SPLIT DOWN THE MIDDLE. PICC REMOVED. NEW PICC PLACED FOR COMPLETION OF PRESCRIBED THERAPY.

  Patient problems: Insufficient Information

  MAUDE report 10656178 ↗
• MalfunctionSep 2, 2020Crack; Material Split, Cut or Torn

  ITEM #384467/LOT# 11267058 WAS INSERTED (DATE UNAVAILABLE). ON THE 45TH DAY OF DWELL THE HUB EXPERIENCED A LITTLE CRACK THEN SPLIT DOWN THE MIDDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10483844 ↗
• MalfunctionSep 2, 2020Crack; Material Split, Cut or Torn

  FOLLOW UP.

  Patient problems: Insufficient Information

  MAUDE report 10483647 ↗
• MalfunctionSep 2, 2020Crack; Material Split, Cut or Torn

  ITEM #384467/LOT# 11267058 WAS INSERTED (DATE UNAVAILABLE). ON THE 32ND DAY OF DWELL THE HUB EXPERIENCED A LITTLE CRACK THEN SPLIT DOWN THE MIDDLE.

  Patient problems: Insufficient Information

  MAUDE report 10483478 ↗
• MalfunctionSep 2, 2020Crack; Material Split, Cut or Torn

  ITEM #384467/LOT# 11267058 WAS INSERTED (DATE UNAVAILABLE). ON THE 54TH DAY OF DWELL THE HUB EXPERIENCED A LITTLE CRACK THEN SPLIT DOWN THE MIDDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10482962 ↗
• MalfunctionSep 1, 2020Crack; Material Split, Cut or Torn

  ITEM #384467/LOT# 11267058 WAS INSERTED (DATE UNAVAILABLE). ON THE 82ND DAY OF DWELL THE HUB EXPERIENCED A LITTLE CRACK THEN SPLIT DOWN THE MIDDLE.

  Patient problems: Insufficient Information

  MAUDE report 10478276 ↗
• MalfunctionSep 1, 2020Crack

  ITEM #384467/LOT# 11267058 WAS INSERTED (DATE UNAVAILABLE). ON THE 12TH DAY OF DWELL THE HUB EXPERIENCED A LITTLE CRACK THEN SPLIT DOWN THE MIDDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10478258 ↗
• MalfunctionSep 1, 2020Crack; Material Split, Cut or Torn

  THERE HAVE BEEN 8 OCCASIONS THAT WHEN THE PICC IS ABOUT 1 MONTH OLD AND THE MALE PORTION OF IV TUBING CONNECTED AND TIGHTENED TO HUB, THE HUB IS GETTING A LITTLE CRACK THEN SPLITS DOWN THE MIDDLE.

  Patient problems: Insufficient Information

  MAUDE report 10478080 ↗
• MalfunctionJun 10, 2020Crack

  WE HAD ANOTHER ONE CRACK AT THE HUB AGAIN LAST NIGHT. THIS BRINGS OUR TOTAL TO 7 OVER THE LAST FIVE MONTHS. (B)(6): ¿ WAS THERE ANY HARM TO THE PATIENT. NO, JUST AN ADDITIONAL TRIP TO IR TO HAVE A NEW LINE PLACED. ¿ WAS A NEW PICC PLACED TO CONTINUE PRESCRIBED THERAPY. YES, A 4 FR DL BARD. ¿ WAS A NEW PIV PLACED TO CONTINUE PRESCRIBED THERAPY. YES. ¿ WAS A NEEDLES CONNECTOR PLACED ON THE HUB OF THE RED AND BLUE LUMENS. YES. ¿ IS THE PRODUCT AVAILABLE TO BE RETURNED TO ARGON QUALITY FOR PRODUCT EVALUATION/INVESTIGATION. YES. ¿ WHAT IS THE LOT# OF THE PRODUCT. 11293336.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140872 ↗
• MalfunctionJun 4, 2020Crack

  FOLLOW UP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10121104 ↗
• MalfunctionApr 28, 2020Crack

  FOLLOW UP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10007269 ↗