PowerPICC Catheter 3275155Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741027932), received between May 9, 2018 and Apr 2, 2026 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Material Deformation

  IT WAS REPORTED THAT THE SHEATH IS DAMAGED AND CANNOT HOLD A PERSON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767375 ↗
• MalfunctionMar 18, 2026Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE DOCTOR WAS PLACING THE PICC, THERE WAS NO ABNORMALITY WITH THE GUIDE WIRE. BUT WHEN THE GUIDE WIRE WAS WITHDRAWN, IT WAS FOUND TO BE BENT AND FORKED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626442 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED VIA MEDSUN THAT REPORTING RN NOTIFIED THAT PATIENTS IV CATHETER LINE BROKE INTO RED LUMEN OF PICC LINE. NO HARM TO PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24297532 ↗
• MalfunctionJan 26, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PICC INSERTION PROCEDURE, AFTER SUCCESSFULLY ADVANCING THE GUIDEWIRE, THE DILATOR INTENDED FOR ADVANCING THE PICC GUIDEWIRE WAS FOUND TO BE DEFECTIVE AND COULD NOT PERFORM DILATION. AS A RESULT, THE PHYSICIAN DISCARDED THE DEFECTIVE DILATOR AND PROCEEDED WITH A NEW PICC KIT TO COMPLETE THE PROCEDURE. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182593 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT ONE OF THE TWO-LUMEN CATHETERS BROKE OFF AT THE ADMINISTRATION SITE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727995 ↗
• MalfunctionOct 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SHEATH WAS TOO SOFT TO INSERT. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425192 ↗
• MalfunctionAug 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT WATER SEEPAGE FROM THE EXPOSED CROOKED PICC CONDUIT APPEARS LIKE A FOUNTAIN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881423 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER FRACTURED BELOW THE WINGS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21903866 ↗
• InjuryFeb 26, 2025Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "WHILE INSERTING A PICC LINE AND ADVANCING THE GUIDEWIRE, RESISTANCE WAS ENCOUNTERED. UNDER FLUOROSCOPY, IT WAS IDENTIFIED THAT THE GUIDEWIRE FOLDED/BENT ON TO ITSELF. ATTEMPTING TO REMOVE THE GUIDEWIRE, IT BECAME "STUCK" AND BROKE OFF IN THE PATIENT'S SUBCUTANEOUS TISSUE, THERE IS AN APPROXIMATE 1-2MM RETAINED PIECE OF GUIDEWIRE."

  Patient problems: Foreign Body In Patient

  MAUDE report 21469044 ↗
• InjuryFeb 25, 2025Material Frayed; Material Frayed

  IT WAS REPORTED BY MEDWATCH THAT WHILE INSERTING A PICC LINE AND ADVANCING THE GUIDEWIRE, RESISTANCE WAS ENCOUNTERED. UNDER FLUOROSCOPY, IT WAS IDENTIFIED THAT THE GUIDEWIRE FOLDED/BENT ON TO ITSELF. ATTEMPTING TO REMOVE THE GUIDEWIRE, IT BECAME "STUCK" AND BROKE OFF IN THE PATIENT'S SUBCUTANEOUS TISSUE OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 14TH: THE RETAINED BROKEN PIECE OF THE GUIDEWIRE. THIS WAS NOT TREATED. IT WAS DETERMINED IT WOULD CAUSE MORE DAMAGE TO THE PATIENT TO TRY TO RETRIEVE THE BROKEN PIECE, SO THE DECISION WAS MADE TO LEAVE IT IN THE SOFT TISSUE. THE PATIENT CAME BACK TO THE ED WITH MULTIPLE COMPLAINTS INCLUDING PAIN AND TENDERNESS AT THE SITE OF THE RETAINED PIECE OF GUIDEWIRE. CENTRAL LINE WAS PLACED ONCE PATIENT RETURNED TO ICU.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 21462253 ↗
• MalfunctionJan 23, 2025Break; Break

  IT WAS REPORTED ONE OF THE LUMENS GOT RIPPED OFF BY PATIENT. IT WAS NOT PULLED OUT FROM THE SKIN ITSELF. THE LINE WAS CLAMPED AT THE POINT THEY COULD. THEN IT WAS REMOVED 4HRS LATER. NO HARM WAS DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223319 ↗
• MalfunctionNov 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED OF A TUBE LEAKAGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20627038 ↗
• MalfunctionAug 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S CATHETER WAS FOUND TO BE RUPTURED AND LEAKING DURING DRUG INFUSION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933698 ↗
• MalfunctionJun 19, 2024Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DILATOR BIFURCATION CANNOT HELP PATIENTS PLACE CATHETERS. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567498 ↗
• InjuryJan 10, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING USE, GUIDEWIRE BROKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18484237 ↗
• MalfunctionJan 26, 2023Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT THE PINK HUB LEAK AND CAUSE THE ASPIRATION FAILURE. PICC CHANGED. NO PATIENT INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250327 ↗
• MalfunctionJan 4, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TIP OF SHEATH IS UNEVEN. PATIENT STATUS/ INTERVENTION: IT WAS STATED THE PATIENT IS FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098506 ↗
• MalfunctionAug 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRODUCER WAS FORKED AND NOT AVAILABLE TO USE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255238 ↗
• MalfunctionAug 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT NURSE FOUND THE DEVICE DAMAGED AND LEAKED DURING THE INFUSION AND REPLACED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15249143 ↗
• MalfunctionMar 15, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING CATHETER INSERTION, THE CATHETER WAS FOUND DIFFICULT TO INSERT. AFTER REMOVAL, THE WIRE AND CATHETER WERE FOUND DEFORMED. (B)(6) 2022- THE RETURNED GUIDEWIRE WAS BROKEN.

  MAUDE report 13764981 ↗
• MalfunctionApr 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE FRONT BIFURCATION OF THE INTRODUCER, CANNOT BE USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752265 ↗
• MalfunctionDec 12, 2020Component Incompatible; Fluid/Blood Leak; Component Incompatible

  IT WAS REPORTED THAT THE CATHETER LEAKED FROM THE CONNECTOR (GRAY PART). A NEW DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10995950 ↗
• MalfunctionSep 3, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT BENDING GUIDE WIRE, DIFFICULT REMOVE. OPEN NEW MICROINTRODUCER. ON 8/13/2020 RETURNED WIRE IS FRAYED.

  Patient problems: No Patient Involvement

  MAUDE report 10490946 ↗
• MalfunctionFeb 20, 2019Break

  IT WAS REPORTED VIA MEDWATCH, "DURING A MIDLINE PICC PLACEMENT, THE 0.018 INCH GUIDE WIRE FROM THE BARD POWERPICC BROKE AND UNRAVELED IN THE RIGHT AXILLARY VEIN OF PATIENT. THE DOCTOR THEN UTILIZED A SNARE TO RETRIEVE THE ENTIRE WIRE". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8354439 ↗
• InjuryMay 9, 2018Break; Unraveled Material

  IT WAS REPORTED THAT THE FACILITY HAD A PICC WIRE THAT CAME UNRAVELED AND BROKE IN TWO PIECES DURING PLACEMENT. THE BROKEN WIRE PARTS WERE RETRIEVED BY DOCTORS USING A SNARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7498698 ↗