PowerPICC SV Catheter 1274118Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741086915), received between Nov 9, 2017 and Jun 19, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Defective Component” (9 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.

• MalfunctionJun 19, 2026Fluid/Blood Leak

  IT WAS REPORTED PICC - RIGHT BRACHIAL. LINE BROKEN AT THE JUNCTURE WHERE IT MEETS THE WHITE WING PART. NO APPARENT HARM. OF NOTE, THIS PICC WAS INSERTED VERY LOW ON THE ARM, AND THE BREAK HAPPENED WHERE THE LINE WAS LOOPED BACK UPWARDS SO AS TO AVOID THE ANTECUBITAL FOLD. SECOND PICC BREAK FOR THIS PATIENT, INDWELLING FOR 37 DAYS. ADDITIONAL INFORMATION RECEIVED ON 6/2/2026: PICC WAS A PARTIAL BREAK THROUGH CATHETER LUMEN. PICC LINE CAUSED DELAY IN BLOOD DRAW - BLOOD WORK DEFERRED TO FOLLOWING DAY AS IT WAS TOO LATE THEN IN THE MORNING TO DRAW AN ACCURATE DRUG LEVEL. THEREFORE, HE REQUIRED AN ADDITIONAL TRIP TO THE HOSPITAL FOR THIS BLOOD DRAW. PICC SECURED WITH SECURACATH & SECUREMENT DRESSING IV ADVANCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25564914 ↗
• MalfunctionJun 16, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT WHITE LUMEN CRACKED AND LEAKING. NO APPARENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524207 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN REMOVING THE DRESSING, THERE WAS NO KINK OR INCORRECT PLACEMENT OF THE LINE UNDER THE DRESSING. IT WAS IN A NICE U-TURN. BREAK OCCURRED ABOUT 0.5-1.0 CM ABOVE THE WHITE WINGS. CHEMO NURSES ARE VERY EXPERIENCED IN CVC DRESSINGS AND PAY SPECIAL ATTENTION TO TAPE UP CORRECTLY TO PRESERVE THE LINE. NO INVASIVE PROCEDURE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634091 ↗
• MalfunctionDec 29, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT ALTERNATE PICC LINES HAVE BEEN CAUSING SIGNIFICANT ISSUES, AS THEY ARE FREQUENTLY OCCLUDING RESULTING IN DELAYED TREATMENT AND RETURNING TO HOSPITAL FOR DE-CLOTTING PROCEDURES AND REDUCED PATIENT COMFORT WHEN TWO LUMENS ARE UNNECESSARY. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919368 ↗
• MalfunctionDec 29, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY CUSTOMER THAT ONE PATIENT WHO WAS RECEIVING CHEMOTHERAPY REQUIRED DECLOTTING EVERY WEEK WHILE ON HER 3-MONTH TREATMENT, CAUSING DELAYS IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919367 ↗
• MalfunctionDec 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT RN PREPARING TO ADMINISTER ANTIBIOTICS TO PATIENT, DURING INITIAL ACCESSING OF LINE (SALINE FLUSH) NOTICED A LEAK UNDER THE DRESSING DISTAL TO STATLOCK. LINE CRACK DISTAL TO STABILIZATION AREA. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23842324 ↗
• MalfunctionNov 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT PICC DRESSING CHANGE DUE TODAY. WHEN CHANGED LINE WAS NOTED TO BE LEAKAGE FROM INSERTION SITE. PICC TEAM CALLED STATED LINE WAS LIKELY CRACKED. DRESSING WAS SATURATED AND FROM 3CG LINE PULLED OUT SLIGHTLY MOVEMENT OF PT. ACCIDENTALLY. CATHETER WAS SECURED WITH STATLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634261 ↗
• MalfunctionDec 6, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT BLOOD LEAKING AROUND STYLET AT T-PIECE STOPPER, DURING INSERTION, UNABLE TO FLUSH THAT LUMEN WITHOUT SUCKING AIR AND CAUSING LEAKING. THERE WAS NO HARM TO THE PATIENT. INSERTION CARRIED ON DESPITE THE LEAKING, STYLET AND RUBBER STOPPER REMOVED AND DISCARDED POST INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278862 ↗
• MalfunctionNov 8, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT INSERTING THIS PICC, WE ARE UNABLE TO DRAW BLOOD FROM PURPLE LUMEN AS IT ONLY PULLS AIR THROUGH THE RUBBER HUB WHERE STYLET PASSES THROUGH. ABLE TO SAFELY INSERT SING OTHER LUMEN. NO HARM TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089530 ↗
• MalfunctionOct 18, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THEY ARE UNABLE TO DRAW BLOOD BACK THROUGH THE EXTENSION TUBING ON THE STYLET LUMEN OF THE PICC DURING INSERTION. SUCKING AIR NOT BLOOD. THIS HAS OCCURRED ON 6 OCCASIONS NOT SURE OF DATES. SOME HAVE HAD VISIBLE LEAKING OF NORMAL SALINE WHERE THE STYLET EXITS THE STOPPER. ALL PICC'S WERE FLUSHED PRIOR TO INSERTION, CUSTOMER WAS ABLE TO REMOVE THE STYLET ONCE INSERTED CORRECTLY AND DRAW BLOOD DIRECTLY FROM THE HUB OF THE CATHETER WITHOUT DIFFICULTY. THE CUSTOMER OPENED A KIT FROM THE SAME LOT FOR A DEMONSTRATION OF THE ISSUE. THIS REPORT ADDRESSES THE FIRST DEVICE USED ON A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17959546 ↗
• MalfunctionOct 18, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THEY ARE UNABLE TO DRAW BLOOD BACK THROUGH THE EXTENSION TUBING ON THE STYLET LUMEN OF THE PICC DURING INSERTION. SUCKING AIR NOT BLOOD. THIS HAS OCCURRED ON 6 OCCASIONS NOT SURE OF DATES. SOME HAVE HAD VISIBLE LEAKING OF NORMAL SALINE WHERE THE STYLET EXITS THE STOPPER. ALL PICC'S WERE FLUSHED PRIOR TO INSERTION, CUSTOMER WAS ABLE TO REMOVE THE STYLET ONCE INSERTED CORRECTLY AND DRAW BLOOD DIRECTLY FROM THE HUB OF THE CATHETER WITHOUT DIFFICULTY. THE CUSTOMER OPENED A KIT FROM THE SAME LOT FOR A DEMONSTRATION OF THE ISSUE. THIS REPORT ADDRESSES THE THIRD DEVICE USED ON A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17959538 ↗
• MalfunctionOct 18, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THEY ARE UNABLE TO DRAW BLOOD BACK THROUGH THE EXTENSION TUBING ON THE STYLET LUMEN OF THE PICC DURING INSERTION. SUCKING AIR NOT BLOOD. THIS HAS OCCURRED ON 6 OCCASIONS NOT SURE OF DATES. SOME HAVE HAD VISIBLE LEAKING OF NORMAL SALINE WHERE THE STYLET EXITS THE STOPPER. ALL PICC'S WERE FLUSHED PRIOR TO INSERTION, CUSTOMER WAS ABLE TO REMOVE THE STYLET ONCE INSERTED CORRECTLY AND DRAW BLOOD DIRECTLY FROM THE HUB OF THE CATHETER WITHOUT DIFFICULTY. THE CUSTOMER OPENED A KIT FROM THE SAME LOT FOR A DEMONSTRATION OF THE ISSUE. THIS REPORT ADDRESSES THE SIXTH DEVICE USED ON A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17959521 ↗
• MalfunctionOct 18, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THEY ARE UNABLE TO DRAW BLOOD BACK THROUGH THE EXTENSION TUBING ON THE STYLET LUMEN OF THE PICC DURING INSERTION. SUCKING AIR NOT BLOOD. THIS HAS OCCURRED ON 6 OCCASIONS NOT SURE OF DATES. SOME HAVE HAD VISIBLE LEAKING OF NORMAL SALINE WHERE THE STYLET EXITS THE STOPPER. ALL PICC'S WERE FLUSHED PRIOR TO INSERTION, CUSTOMER WAS ABLE TO REMOVE THE STYLET ONCE INSERTED CORRECTLY AND DRAW BLOOD DIRECTLY FROM THE HUB OF THE CATHETER WITHOUT DIFFICULTY. THE CUSTOMER OPENED A KIT FROM THE SAME LOT FOR A DEMONSTRATION OF THE ISSUE. THIS REPORT ADDRESSES THE FIFTH DEVICE USED ON A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17959516 ↗
• MalfunctionOct 18, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THEY ARE UNABLE TO DRAW BLOOD BACK THROUGH THE EXTENSION TUBING ON THE STYLET LUMEN OF THE PICC DURING INSERTION. SUCKING AIR NOT BLOOD. THIS HAS OCCURRED ON 6 OCCASIONS NOT SURE OF DATES. SOME HAVE HAD VISIBLE LEAKING OF NORMAL SALINE WHERE THE STYLET EXITS THE STOPPER. ALL PICC'S WERE FLUSHED PRIOR TO INSERTION, CUSTOMER WAS ABLE TO REMOVE THE STYLET ONCE INSERTED CORRECTLY AND DRAW BLOOD DIRECTLY FROM THE HUB OF THE CATHETER WITHOUT DIFFICULTY. THE CUSTOMER OPENED A KIT FROM THE SAME LOT FOR A DEMONSTRATION OF THE ISSUE. THIS REPORT ADDRESSES THE SECOND DEVICE USED ON A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17959514 ↗
• MalfunctionOct 18, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THEY ARE UNABLE TO DRAW BLOOD BACK THROUGH THE EXTENSION TUBING ON THE STYLET LUMEN OF THE PICC DURING INSERTION. SUCKING AIR NOT BLOOD. THIS HAS OCCURRED ON 6 OCCASIONS NOT SURE OF DATES. SOME HAVE HAD VISIBLE LEAKING OF NORMAL SALINE WHERE THE STYLET EXITS THE STOPPER. ALL PICC'S WERE FLUSHED PRIOR TO INSERTION, CUSTOMER WAS ABLE TO REMOVE THE STYLET ONCE INSERTED CORRECTLY AND DRAW BLOOD DIRECTLY FROM THE HUB OF THE CATHETER WITHOUT DIFFICULTY. THE CUSTOMER OPENED A KIT FROM THE SAME LOT FOR A DEMONSTRATION OF THE ISSUE. THIS REPORT ADDRESSES THE FOURTH DEVICE USED ON A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17959513 ↗
• MalfunctionOct 18, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THEY ARE UNABLE TO DRAW BLOOD BACK THROUGH THE EXTENSION TUBING ON THE STYLET LUMEN OF THE PICC DURING INSERTION. SUCKING AIR NOT BLOOD. THIS HAS OCCURRED ON 6 OCCASIONS NOT SURE OF DATES. SOME HAVE HAD VISIBLE LEAKING OF NORMAL SALINE WHERE THE STYLET EXITS THE STOPPER. ALL PICC'S WERE FLUSHED PRIOR TO INSERTION, CUSTOMER WAS ABLE TO REMOVE THE STYLET ONCE INSERTED CORRECTLY AND DRAW BLOOD DIRECTLY FROM THE HUB OF THE CATHETER WITHOUT DIFFICULTY. THE CUSTOMER OPENED A KIT FROM THE SAME LOT FOR A DEMONSTRATION OF THE ISSUE. THIS REPORT ADDRESSES THE DEMONSTRATION LOT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959310 ↗
• InjuryAug 9, 2023Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "ULTRASOUND GUIDANCE WAS USED TO IDENTIFY VEIN. DYNAMIC, REAL-TIME IMAGING OF VESSEL CANNULATION PERFORMED. STERILE GEL AND PROBE COVER USED IN ULTRASOUND-GUIDED CENTRAL VENOUS CATHETER INSERTION. CHLORAPREP ANTISEPTIC USED DURING CENTRAL VENOUS CATHETER INSERTION. SKIN PREP AGENT COMPLETELY DRIED PRIOR TO PROCEDURE. HAND HYGIENE PERFORMED PRIOR TO CENTRAL VENOUS. CAP, MASK, STERILE GOWN, STERILE GLOVES AND STERILE DRAPE USED. LEFT BASILIC VEIN WAS LOCATED USING ULTRASOUND, NEEDLE WAS PLACED WITH BLOOD RETURN, GUIDEWIRE WAS ADVANCED 5-10 CM UNTIL THERE WAS RESISTANCE AND SO ADVANCEMENT WAS STOPPED AND GUIDEWIRE WAS PULLED BACK ALONG WITH THE NEEDLE 2-3 CM UNTIL RESISTANCE WAS MET AND STOPPED. ATTEMPTED TO REMOVE NEEDLE AND GUIDEWIRE TOGETHER BUT WAS UNABLE TO DO SO. NEEDLE WAS EASILY REMOVED OVER THE GUIDEWIRE. PROCEDURE WAS ABORTED. WITH THE GUIDEWIRE REMAINING IN PLACE, PRESSURE WAS APPLIED TO THE SITE WITH MINIMAL BLEEDING. LIDOCAINE WAS ADMINISTERED AT SITE AND PATIENT WAS GIVEN IV MORPHINE FOR PAIN CONTROL. SURGEONS WERE NOTIFIED, DOCTORS ALL RESPONDED TO BEDSIDE TO EVALUATE PATIENT. X-RAY WAS COMPLETED. DECISION WAS MADE TO TAKE PATIENT TO OPERATI

  Patient problems: Foreign Body In Patient

  MAUDE report 17490728 ↗
• MalfunctionApr 28, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT PICC WAS INSERTED (B)(6) 2019. ON (B)(6) WITHDRAWAL OCCLUSION NOTED. TPA UNSUCCESSFUL. CXR AS PICC ALSO MIGRATED, AND KINK NOTED IN UPPER ARM ON XRAY. PICC REMOVED (B)(6). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10007889 ↗
• MalfunctionNov 9, 2017Fluid/Blood Leak

  PER MEDWATCH IT WAS REPORTED THAT THE CATHETER WAS LEAKING AT THE BASE OF THE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7013740 ↗