NA P1PIC1.4-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00858778006058), received between Jan 21, 2020 and Aug 4, 2026 — classified as 11 injuries, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Fluid/Blood Leak

  It was reported that the Peripherally Inserted Central Catheter (PICC) line was leaking at the insertion site. When the line was removed the leak was noted at just distal to the hub. Although it was reported that the patient had no clinical signs, symptoms, or conditions, the event was reported as a serious injury that required intervention. The type of intervention was not reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132455 ↗
• MalfunctionMay 18, 2026

  DURING PERIPHERALLY INSERTED CENTRAL CATHETER LINE INSERTION ATTEMPT USING 1.4 FRENCH PICC LINE ( LOT#250584 EXPIRATION 2027-08-07) CATHETER SEPARATED/BROKE WHILE HUB WAS BEING REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209174 ↗
• InjuryApr 30, 2026Break

  IT WAS REPORTED THAT AFTER THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) HAD BEEN PLACED IN THE PATIENT, THE CATHETER SNAPPED COMPLETELY. THE REPORT DID NOT INDICATE THE CATHETER SEPARATION LOCATION, OR IF THERE WERE ANY INTERVENTIONS PERFORMED OR HEALTH IMPACTS TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 25046054 ↗
• InjuryApr 29, 2026Break

  IT WAS REPORTED THAT AFTER THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) HAD BEEN PLACED IN THE PATIENT, THE CATHETER SNAPPED. THE REPORT DID NOT INDICATE THE CATHETER SEPARATION LOCATION, OR IF THERE WERE ANY INTERVENTIONS PERFORMED OR HEALTH IMPACTS TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 25034412 ↗
• MalfunctionMar 13, 2026

  THIS RN WENT INTO PATIENT'S ROOM SHORTLY BEFORE 0200 TO START CARES. UPON OPENING PATIENT'S SLEEP SACK THIS RN NOTED FLUID ON CLOTHING AND BLOOD UNDERNEATH PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] DRESSING THAT WAS NOT THERE PREVIOUSLY. RN ASSESSED PICC LINE AND NOTED IT HAD BEEN FULLY SEVERED TOWARD THE EDGE OF THE TAPE. THE PICC TAIL WAS STILL ATTACHED TO THE DRESSING. THIS RN NOTIFIED TRANSPORT RN TO COME TO BEDSIDE. PICC WAS CLAMPED WITH HEMOSTATS AND REMOVED. ENTIRE PICC CATHETER WAS ACCOUNTED FOR WITH TIP INTACT. NEW PICC INSERTION WAS ATTEMPTED FOUR TIMES WITH NO SUCCESS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture

  MAUDE report 24589505 ↗
• InjuryOct 22, 2025Break; Fluid/Blood Leak; Difficult to Remove; Stretched; Break; Fluid/Blood Leak; Difficult to Remove; Stretched

  IT WAS REPORTED THAT DURING A DRESSING CHANGE A LEAK WAS NOTED IN THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE AND THE PROVIDER DECIDED TO REMOVE THE LINE. THE PICC LINE WAS CLAMPED DUE TO BLOOD DRIPPING OUT. RESISTANCE WAS ENCOUNTERED WHEN WITHDRAWING THE PICC, AND THEN THE PICC LINE BROKE OUTSIDE THE PATIENT. AN ADDITIONAL BEDSIDE ATTEMPT WAS MADE TO REMOVE THE PICC LINE, WITH RESISTANCE AGAIN ENCOUNTERED. IT WAS REPORTED THAT THE PORTION OF THE LINE REMOVED DURING THE SECOND ATTEMPT APPEARED STRETCHED. IMAGING SHOWED THAT THE PICC LINE HAD SEPARATED AND A PORTION REMAINED IN THE PATIENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF THE RETAINED PORTION.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23360822 ↗
• InjuryMar 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING ATTEMPTED REMOVAL FROM LEFT SCALP, THE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE RETAINED APPROXIMATELY 10 CM.

  Patient problems: Foreign Body In Patient

  MAUDE report 18886655 ↗
• MalfunctionSep 18, 2023

  PICC LINE FOUND TO BE LEAKING DURING LINE INSERTION. UNABLE TO FLUSH THROUGH AND REPRODUCE THIS AS THE LINE HAS CLOTTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764259 ↗
• InjuryDec 9, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING ATTEMPTS TO REMOVE THE CATHETER FROM THE PATIENT ON (B)(6) 2022. ATTEMPTS TO REMOVE THE CATHETER RESULTED IN THE CATHETER BREAKING AND A 3 CM PORTION REMAINING IN THE PATIENT. THE SEGMENT WAS FULLY REMOVED BY CUTDOWN PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949764 ↗
• InjuryDec 9, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING ATTEMPTS TO REMOVE THE CATHETER FROM THE PATIENT ON (B)(6) 2022. ATTEMPTS TO REMOVE THE CATHETER RESULTED IN THE CATHETER BREAKING AND A 4 CM PORTION REMAINING IN THE PATIENT. THE SEGMENT WAS FULLY REMOVED IN THE CARDIAC CATH LAB.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949645 ↗
• InjuryAug 24, 2022Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING ATTEMPTS TO REMOVE THE CATHETER FROM THE PATIENT ON (B)(6) 2022. ATTEMPTS TO REMOVE THE CATHETER BY INTERVENTIONAL RADIOLOGY WERE UNSUCCESSFUL, AND THEREFORE SURGERY WAS PERFORMED TO EXTRACT THE CATHETER ON (B)(6) 2022.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15286893 ↗
• InjuryJul 1, 2022Break; Break

  IT WAS REPORTED THAT THE PERIPHERALLY INSERTED CENTRAL CATHETER (PART P1PIC1.4-C, LOT 210456) WAS REMOVED FROM THE PATIENT ON (B)(6) 2022. AT THE TIME OF REMOVAL, THE CATHETER WAS DOCUMENTED TO HAVE BEEN REMOVED IN TOTAL, HOWEVER, AN X-RAY PERFORMED ON (B)(6) 2022 REVEALED A 6CM PORTION OF A CATHETER REMAINED IN THE PATIENT. SURGICAL REMOVAL OF THE REMAINING PORTION WAS PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, 5CM OF A 6CM LENGTH WAS REMOVED, LEAVING 1CM IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14886368 ↗
• InjuryOct 26, 2021Break; Break

  IT WAS REPORTED THAT THE PERIPHERALLY INSERTED CENTRAL CATHETER (PART P1PIC1.4-C, LOT 210046) WAS BEING REMOVED FROM THE PATIENT WHEN RESISTANCE WAS ENCOUNTERED AND THE CATHETER SEPARATED LEAVING A PORTION IN THE PATIENT. THE PORTION REMAINING IN THE PATIENT WAS REMOVED THROUGH A CUTDOWN PROCEDURE DURING SURGERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12700962 ↗
• InjuryJan 21, 2020Material Fragmentation; Material Fragmentation

  THE PICC LINE BROKE DURING ATTEMPTED EXTRACTION. THE BROKEN PORTION OF THE CATHETER WAS REMOVED BY RADIOLOGIST. PATIENT IS DOING WELL.

  Patient problems: Injury

  MAUDE report 9613172 ↗