PowerMidline CK000756Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741141126), received between May 12, 2022 and Jun 1, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THERE ARE LEAKING FROM INSERTION SITE ON A MIDLINE PLACED ON 4/29 AND REMOVED 5/2. LINE PLACED ON LEFT CEPHALIC. A NEW CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042573 ↗
• MalfunctionJun 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THERE ARE LEAKING FROM INSERTION SITE ON A MIDLINE THAT WAS PLACED ON 5/2 AND REMOVED ON 5/4/2023. A NEW MIDLINE WAS PLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038400 ↗
• MalfunctionJun 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE MIDLINE WAS LEAKING AT THE INSERTION SITE. ADDITIONAL INFO. RECEIVED: AT WHAT POINT DURING DEVICE USE WAS THE LEAK DISCOVERED (I.E. INSERTION, INFUSION, REMOVAL)WAS THE CATHETER FRACTURE INTERNAL TO THE PATIENT OR EXTERNAL? INFUSION. WHAT WAS INFUSION WHEN THE LEAK WAS DISCOVERED? MEROPENEM. ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? NO. WAS THE CATHETER REMOVED? WAS A NEW CATHETER PLACED? YES AND YES. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STATLOCK. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? MIDLINE. EXPLANT DATE: UNSURE DO TO PATIENT BEING OUTPATIENT AND HOME CARE WAS MANAGING LINE. WAS THERE ANY PATIENT HARM REPORTED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14584208 ↗
• MalfunctionMay 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "FOUND OUT THERE ARE A TOTAL OF 3 MIDLINES FROM THE SAME LOT LEAKING AT THE INSERTION SITE. WHEN THEY PULLED THE MIDLINE AND FLUSHED, EXAMINED THEY DID NOT NOTICE ANYTHING WRONG WITH THE CATHETER BUT THEY HAVE ALSO BEEN USING THESE FOR YEARS WITH NO ISSUES. WE WENT THROUGH SEVERAL TROUBLESHOOTING TECHNIQUES WHICH WE FEEL THIS COULD BE MED OR PATIENT ANATOMY ISSUES BUT STILL WANT TO REPORT. 2 EXCHANGED AND 1 WENT TO NPO MEDS" THIS REPORT ADDRESSES THE NPO MEDS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14388252 ↗
• MalfunctionMay 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "FOUND OUT THERE ARE A TOTAL OF 3 MIDLINES FROM THE SAME LOT LEAKING AT THE INSERTION SITE. WHEN THEY PULLED THE MIDLINE AND FLUSHED, EXAMINED THEY DID NOT NOTICE ANYTHING WRONG WITH THE CATHETER BUT THEY HAVE ALSO BEEN USING THESE FOR YEARS WITH NO ISSUES. WE WENT THROUGH SEVERAL TROUBLESHOOTING TECHNIQUES WHICH WE FEEL THIS COULD BE MED OR PATIENT ANATOMY ISSUES BUT STILL WANT TO REPORT. 2 EXCHANGED AND 1 WENT TO NPO MEDS" THIS REPORT ADDRESSES THE SECOND EXCHANGED MIDLINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14388248 ↗
• MalfunctionMay 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "FOUND OUT THERE ARE A TOTAL OF 3 MIDLINES FROM THE SAME LOT LEAKING AT THE INSERTION SITE. WHEN THEY PULLED THE MIDLINE AND FLUSHED, EXAMINED THEY DID NOT NOTICE ANYTHING WRONG WITH THE CATHETER BUT THEY HAVE ALSO BEEN USING THESE FOR YEARS WITH NO ISSUES. WE WENT THROUGH SEVERAL TROUBLESHOOTING TECHNIQUES WHICH WE FEEL THIS COULD BE MED OR PATIENT ANATOMY ISSUES BUT STILL WANT TO REPORT. 2 EXCHANGED AND 1 WENT TO NPO MEDS" THIS REPORT ADDRESSES THE FIRST EXCHANGED MIDLINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14383943 ↗