NA P1PIC1.4-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00858778006072), received between Aug 22, 2017 and Sep 23, 2026 — classified as 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874626 ↗
• InjurySep 15, 2026Break

  It was reported by customer that the nurse was checking patient's glucose via bedside glucometer. Glucose read 12 when prior glucose obtained at 1530 was 67. RN double checked the D30 fluid was running on the IV pump, then checked that the patient's continuous feed of 3mLs was running and appropriately connected. RN then double checked that the PICC was patent and upon investigating, the PICC dressing was completely occlusive with no border lifting but the piece of the catheter just past the wings of the external portion of the PICC was completely snapped and separated from the rest of the catheter still connected to the patient. nurse immediately called the APN to the bedside who held the PICC remaining in the patient's arm so it did not migrate until a plan was formed. No patient harm reported.

  Patient problems: Hypoglycemia

  MAUDE report 50778999 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak

  It was reported while performing a routine dressing change, PICC noted to have increased amounts of crystallization and once exposed, line noted to have a significant hole. Blood was able to back up into PICC once hole exposed and it almost looked like it was going to snap in two. PICC discontinued immediately and replaced.Catheter secured wtih tegaderm and hubguard, cleaned with chloraprep and dressing changed PRN. Infusates used include TPN, SMOF/lipids, antibiotics, antifungal. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693904 ↗
• MalfunctionSep 8, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675478 ↗
• MalfunctionSep 8, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675477 ↗
• MalfunctionSep 8, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675476 ↗
• InjurySep 8, 2026Break

  It was reported via MedWatch that fractured PICC fragment seen at the SVC. Xray finding revealed there is a PICC which projects at the Superior Vena Cava. PICC is discontinuous, with a defect seen at the subclavian. 28 week, 2 day gestation premature, twin neonate at the time of birth. Neonate had a PICC line placed to the left extremity.

  Patient problems: Foreign Body In Patient

  MAUDE report 50674241 ↗
• MalfunctionSep 8, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674240 ↗
• MalfunctionSep 2, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50575111 ↗
• MalfunctionSep 2, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50575100 ↗
• MalfunctionSep 2, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573251 ↗
• MalfunctionAug 25, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436574 ↗
• InjuryAug 25, 2026Break

  It was reported via MedWatch that fractured PICC fragment seen at the SVC. Xray finding revealed there is a PICC which projects at the Superior Vena Cava. PICC is discontinuous, with a defect seen at the subclavian. 28 week, 2 day gestation premature, twin neonate at the time of birth. Neonate had a PICC line placed to the left extremity.

  Patient problems: Insufficient Information

  MAUDE report 50431554 ↗
• InjuryJun 2, 2026Break; Difficult to Remove

  IT WAS REPORTED THAT DURING REMOVAL OF THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC), RESISTANCE WAS ENCOUNTERED AND THE PICC LINE FRACTURED LEAVING 11.5 CM IN THE PATIENT'S LEG. THE PATIENT WAS TAKEN TO ANOTHER FACILITY FOR SURGERY TO REMOVE THE RETAINED SEGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25361434 ↗
• InjuryFeb 25, 2026Difficult to Remove; Obstruction of Flow

  IT WAS REPORTED THAT THE CATHETER OCCLUDED DURING USE AFTER 65 DAYS OF USE. DURING ATTEMPTS TO REMOVE THE CATHETER, RESISTANCE WAS ENCOUNTERED. SURGERY WAS PERFORMED TO REMOVE THE CATHETER FROM THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24446317 ↗
• InjuryJan 5, 2026Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT AS THE CATHETER WAS BEING REMOVED DUE TO COMPLETION OF TREATMENT, RESISTANCE WAS EXPERIENCED AND IT APPEARED THE LINE WAS STRETCHING DURING REMOVAL, RESULTING IN THE CATHETER SEPARATING. IT WAS CONFIRMED BY X-RAY THAT APPROXIMATELY 3 CM OF THE CATHETER REMAINED IN THE PATIENT. INTERVENTIONAL RADIOLOGY WAS NOT ABLE TO REMOVE THE 3 CM SEPARATED SEGMENT. THE REPORTING FACILITY NOTED THAT ULTRASOUND IMAGING SHOWED A FIBRIN SHEATH AROUND THE TIP OF THE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 23965878 ↗
• InjuryAug 21, 2025Infusion or Flow Problem

  SINCE [DATE REDACTED] - LESS THAN ONE MONTH, HAVE BEEN 3 INDWELLING PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] REQUIRING REMOVAL DUE TO OCCLUSION. THEY HAVE ALL BEEN THE SAME BRAND AND LOT#, 1.4FR PICC(S) FROM THE FOOTPRINT BRAND, LOT# 250098. PATIENT 1: PICC PLACED [DATE REDACTED]. REMOVED: THREE DAYS LATER [DATE REDACTED] - UNABLE TO FLUSH/OCCLUDED PATIENT WAS RECEIVING BOTH TPN AND AMPICILLIN. TPN PAUSED AND LINE CLAMPED WHILE AMPICILLIN WAS GIVEN. PATIENT 2: PICC PLACED [DATE REDACTED]. REMOVED THE FOLLOWING DAY [DATE REDACTED] - UNABLE TO FLUSH/OCCLUDED PATIENT WAS RECEIVING BOTH TPN AND AMPICILLIN. TPN PAUSED AND LINE CLAMPED WHILE AMPICILLIN WAS GIVEN. ADDITIONAL PICC PLACED [DATE REDACTED], REMOVED (PULLED OUT) ON [DATE REDACTED] - APPROXIMATELY 30 DAYS LATER. AT THIS TIME THE CLOT WAS NOTED. PATIENT WAS TREATED FOR LEFT CEPHALIC SUPERFICIAL VENOUS THROMBUS. ADDITIONAL PICC PLACED [DATE REDACTED], LOVENOX (ENOXAPARIN) GIVEN TO TREAT THROMBOSIS. PICC WAS REMOVED ON [DATE REDACTED] - 10 DAYS LATER, WITH NO ISSUES WITH THE LINE. PATIENT 3: PICC PLACED [DATE REDACTED]. REMOVED [DATE REDACTED] - APPROXIMATELY 7 DAYS LATER - UNABLE TO FLUSH/OCCLUDED PATIENT WAS RECEIVING BOTH

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22859975 ↗
• InjuryMay 8, 2025Break; Break

  IT WAS REPORTED THAT DURING REMOVAL OF THE CATHETER FROM THE PATIENT A PIECE OF CATHETER BROKE OFF AND REMAINED IN THE VESSEL. THE SEPARATED PORTION WAS RETRIEVED SURGICALLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21986633 ↗
• InjuryOct 14, 2020Physical Resistance/Sticking

  FOOTPRINT MEDICAL INC., 1.4 FR PEEL AWAY SHEATH INTRODUCER DID NOT COMPLETELY SPLIT. A PORTION OF THE SHEATH WAS LEFT ENCIRCLING THE CATHETER AND THE SHEATH COULD NOT BE REMOVED AFTER THE CATHETER WAS INSERTED INTO THE EXTREMELY PREMATURE BABY'S ARM. AS A RESULT THE CATHETER HAD TO BE REMOVED AND REPLACED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10683281 ↗
• MalfunctionAug 30, 2018Leak/Splash; Leak/Splash

  THE PRIMARY RN NOTICED MOISTURE UNDER THE PICC LINE DRESSING. THE CATHETER WAS DISCOVERED TO BE LEAKING APPROXIMATELY 2CM DISTAL OF THE SKIN REFERENCE MARK. THERE WAS NO HARM TO THE INFANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832128 ↗
• MalfunctionAug 22, 2017Material Separation; Material Separation

  THE 1.4 FR POLYURETHANE PIC CATHETER BROKE AT THE SECUREMENT HUB DURING ATTEMPTED EXPLANT. THE PICC WAS IN PLACE FOR APPROXIMATELY FIVE DAYS BEFORE THE ADVERSE EVENT. THERE WAS NO HARM TO THE INFANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811791 ↗