PowerPICC CK000550ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741155758), received between Apr 1, 2021 and Aug 20, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Frayed” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "PATIENT HAD A LOT OF SCAR TISSUE FROM PICCS PLACED IN THE PAST. PATIENT WAS A DIFFICULT ACCESS PATIENT. WHEN ADVANCING PICC THE STYLET GOT STUCK IN THE SCAR TISSUE AND WOULD NOT RETRACT OUT. THE TIP BROKE OFF AND IR HAD TO REMOVE THE STYLET THAT BROKE OFF IN PATIENT." ADDITIONAL INFORMATION RECEIVED 08/03/2021: WAS THERE ANY PATIENT HARM REPORTED? PT HAD TO GO TO THE OR TO HAVE PIECE REMOVED. WHAT THEY'RE BEING TREATED FOR: PICC WAS NEEDED FOR IV ANTIBIOTICS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12351443 ↗
• InjuryApr 26, 2021Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "FLUOROSCOPIC IMAGING OF RIGHT UPPER ARM SHOWED FOREIGN OBJECT - OBJECT WAS RETRIEVED SUCCESSFULLY BY IR MD - OBJECT APPEARED TO BE PORTION OF GUIDEWIRE (PICC WAS ATTEMPTED IN RIGHT ARM ON (B)(6) 2021)."

  Patient problems: Foreign Body In Patient

  MAUDE report 11728465 ↗
• InjuryApr 9, 2021Material Frayed; Material Frayed

  IT WAS REPORTED PATIENT HAD TOUGH PICC STICK THAT ENDED UP BEING CUT TO MIDLINES. AFTER PLACEMENT, TIP OF GUIDEWIRE WAS NEEDING TO BE EXTRACTED FROM PATIENT BY RADIOLOGY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11645325 ↗
• InjuryApr 1, 2021Material Frayed; Material Frayed

  IT WAS REPORTED PATIENT HAD TOUGH PICC STICK THAT ENDED UP BEING CUT TO MIDLINES. AFTER PLACEMENT, TIP OF GUIDEWIRE WERE NEEDING TO BE EXTRACTED FROM PATIENT BY RADIOLOGY. ADDITIONAL INFORMATION RECEIVED 03/19/2021: IT WAS REPORTED THE PATIENT IS BEING TREATED FOR TPN. THE PICC WOULD NOT THREAD TO SVC. MET RESISTANCE. PT REPOSITIONED, ETC TO ATTEMPT TO THREAD TO CENTRAL LOCATION. PICC CUT AT 10 CMS AND LEFT IS PLACE AS A MIDLINE. FLUSHES AND HAS A POSITIVE BLOOD RETURN AT THIS SITE, RN NOTIFIED. LONG TERM TNA USE AND PICC WAS BEING REPLACED. DOES THE PATIENT HAVE AN INFECTIOUS DISEASE?: YES, BEING EVALUATED FOR INTRA-ABDOMINAL ABSCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 11602806 ↗