PowerPICC SOLO CK001028Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741223938), received between Apr 18, 2023 and Aug 12, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (13 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.

• MalfunctionAug 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC WAS INSERTED IN A PATIENT AND WHEN WENT TO CHECK FOR BLOOD RETURN, SHE PULLED BACK AND GOT 6-8 ML OF AIR BEFORE SEEING BLOOD RETURN. SHE TRIED BOTH LUMENS AND THE SAME THING HAPPENED SO THEY DID A PICC EXCHANGE AND PLACED A NEW LINE IN THE PATIENT. THEY WERE UNSURE IF THERE WAS A HOLE SOMEWHERE IN THE PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790374 ↗
• MalfunctionNov 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT MICROINTRODUCER WOULD NOT ADVANCE. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Hematoma

  MAUDE report 20724661 ↗
• MalfunctionNov 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT MICROINTRODUCER WOULD NOT ADVANCE DURING PICC PROCEDURE. THERE HAVE BEEN SEVERAL THAT WOULD NOT ADVANCE, FEW WITH TRAUMA TO THE PATIENT INCLUDING HEMATOMA. NO OTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Hematoma

  MAUDE report 20695898 ↗
• MalfunctionOct 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT NINE PICC KIT INTRODUCER HAD ISSUES WITH DIFFICULT INSERTION. NO OTHER INFORMATION WAS PROVIDED. 09/12/2024: NINE 5FR MICROEZ MICROINTRODUCERS WERE RETURNED FOR EVALUATION, IT WAS FOUND DURING AN INVESTIGATION THERE FIVE OF THE MICROINTRODUCERS HAD DEFORMATION OF THE SHEATH. THIS REPORT ADDRESSES THE FIFTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20430100 ↗
• MalfunctionOct 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT NINE PICC KIT INTRODUCER HAD ISSUES WITH DIFFICULT INSERTION. NO OTHER INFORMATION WAS PROVIDED. 09/12/2024: NINE 5FR MICROEZ MICROINTRODUCERS WERE RETURNED FOR EVALUATION, IT WAS FOUND DURING AN INVESTIGATION THERE FIVE OF THE MICROINTRODUCERS HAD DEFORMATION OF THE SHEATH. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20430068 ↗
• MalfunctionOct 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT NINE PICC KIT INTRODUCER HAD ISSUES WITH DIFFICULT INSERTION. NO OTHER INFORMATION WAS PROVIDED. 09/12/2024: NINE 5FR MICROEZ MICROINTRODUCERS WERE RETURNED FOR EVALUATION, IT WAS FOUND DURING AN INVESTIGATION THERE FIVE OF THE MICROINTRODUCERS HAD DEFORMATION OF THE SHEATH. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20430065 ↗
• MalfunctionOct 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT NINE PICC KIT INTRODUCER HAD ISSUES WITH DIFFICULT INSERTION. NO OTHER INFORMATION WAS PROVIDED. 09/12/2024: NINE 5FR MICROEZ MICROINTRODUCERS WERE RETURNED FOR EVALUATION, IT WAS FOUND DURING AN INVESTIGATION THERE FIVE OF THE MICROINTRODUCERS HAD DEFORMATION OF THE SHEATH. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20430057 ↗
• MalfunctionJun 10, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT INTRODUCER WOULD NOT GO INTO PATIENT AND WOULD NOT STAY TOGETHER. OPENED ANOTHER KIT, NO PATIENT HARM OR TREATMENT. INTRODUCER WAS BUCKLING UPON INSERTION. NO OTHER INFORMATION WAS PROVIDED.05/20/2024: THE RETURNED DEVICE EXHIBITED A DAMAGED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506880 ↗
• MalfunctionMay 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE INTRODUCER WILL NOT INSERT INTO VASCULATURE. PATIENT HAD TO BE ACCESSED TWICE. IT WAS STATED THERE WAS NO HARM TO THE PATIENT. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898654 ↗
• MalfunctionApr 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE INTRODUCER WILL NOT INSERT INTO VASCULATURE. DATE OF EVENT: 4/11/2023. ADDITIONAL INFORMATION RECEIVED 04/14/2023 THE CLINICIAN HAD TO OPEN ANOTHER INTRODUCER KIT TO ACCESS THE PATIENT. THE REPORTED EVENT CAUSED TRAUMA TO THE SKIN AND VESSEL UPON INSERTION BUT NO TREATMENT WAS NEEDED. THE WAS NO HARM OR NEGATIVE OUTCOME TO THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16820543 ↗
• MalfunctionApr 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE INTRODUCER WILL NOT INSERT INTO VASCULATURE. DATE OF EVENT (B)(6) 2023. ADDITIONAL INFO RECEIVED ON (B)(6) 2023 CUSTOMER REPORTED THEY HAD TO DROP ANOTHER INTRODUCER KIT TO ACCESS THE PATIENT. THE EVENT CAUSED TRAUMA TO THE SKIN AND VESSEL UPON INSERTION BUT DID NOT REQUIRE TREATMENT. THERE WAS NO PATIENT HARM OR NEGATIVE OUTCOME. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE-THREATENING MEDICAL SITUATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16820399 ↗
• MalfunctionApr 19, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "INTRODUCER WILL NOT SLIDE IN AS EXPECTED. CUSTOMER SAYS IT IS CAUSING TRAUMA TO THE SKIN AND VESSEL BECAUSE OF FORCE NEEDED TO INSERT THE DEVICE". ADDITIONAL INFORMATION RECEIVED 04/07/2023: OPENED ANOTHER INTRODUCER KIT AND PLACED THE LINE. THERE WERE NO COMPLICATIONS SECONDARY TO THE VESSEL TRAUMA.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16769483 ↗
• MalfunctionApr 18, 2023Material Deformation; Material Deformation

  BD VASCULAR ACCESS DEVICES FIELD ASSURANCE RECEIVED A SHEATH FOR EVALUATION THAT HAD A SPLIT AT THE TIP. NO OTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766087 ↗
• MalfunctionApr 18, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE INTRODUCER WILL NOT SLIDE IN AS EXPECTED, CAUSING TRAUMA TO THE SKIN AND VESSEL BECAUSE OF FORCE NEEDED TO INSERT THE DEVICE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE, THERE WERE NO SERIOUS ADVERSE EVENTS, BUT IT DID CAUSE PATIENT DISCOMFORT AND DELAY IN TREATMENT TIME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16762934 ↗