PowerPICC Provena SOLO CK000409ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741215070), received between Feb 19, 2021 and Jul 22, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TWO 4 FRENCH DUAL LUMEN PROVENA PICC¿S, KINKED IN THE AXILLARY REGION OVER THE LAST TWO DAYS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211271 ↗
• MalfunctionJul 22, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TWO 4 FRENCH DUAL LUMEN PROVENA PICC¿S, KINKED IN THE AXILLARY REGION OVER THE LAST TWO DAYS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211260 ↗
• MalfunctionMay 13, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "ATTEMPTED PICC PLACEMENT - ABLE TO ACCESS VEIN AND THREAD WIRE WITHOUT DIFFICULTY BUT UNABLE TO PASS PICC PAST ~20 CM MARKING. UNABLE TO ADVANCE OR RETRACT PICC OR INNER WIRE. ATTENDING PHYSICIAN AND VASCULAR SURGERY PHYSICIAN NOTIFIED. VASCULAR PHYSICIAN TO BEDSIDE AND ABLE TO REMOVE PICC. PICC CATHETER AND GUIDEWIRE INTACT BUT GUIDEWIRE WAS KINKED AND FRAYED IN SEVERAL AREAS." ADD INFO RCVD D 05/03/2021: PLACEMENT INFO: RIGHT BRACHIAL VEIN. WAS THERE PATIENT HARM REPORTED?: NO. MEDWATCH RECEIVED STATED: PICC CATHETER INTACT, UNABLE TO ADVANCE, CATHETER REMOVED, INNER WIRE WAS KINKED AND FRAYED IN SEVERAL AREAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821321 ↗
• MalfunctionApr 15, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "THIS EVENING THAT A 3CG WIRE BROKE OFF INSIDE OF A PATIENT DURING A PICC INSERTION. NURSE STATED HE HAD NO RESISTANCE INSERTING BUT DID HAVE TO MAKE TWO PASSES TO GET THE PICC TO DROP. HE ALSO HAD NO RESISTANCE WHEN REMOVING THE WIRE. WHEN HE PULLED THE WIRE, HE NOTICED SOMETHING ¿HANGING¿ OUT OF THE SOLO VALVE WHICH ENDED UP BEING 6 3CG MAGNETS THAT WERE ALL STUCK TOGETHER." "THE PICC WAS REMOVED AND A CT OF THE HEAD, CHEST, ABDOMEN AND PELVIS SHOWED NO EVIDENCE OF FOREIGN BODIES. THE PATIENT HAS HAD NO SYMPTOMS, AND A NEW PICC WAS PLACED IN IR." "UPON INSPECTION OF THE WIRE IT HAD BROKEN, SOME DETAILS FROM FACILITY PRODUCT INSPECTION:" 3 MAGNETS IN TACT IN THE WIRE STILL. 6 MAGNETS PULLED OUT OF THE VALVE AND ACCOUNTED FOR. KINK THAT CAN BE SEEN IN THE WIRE HAPPENED DURING TRANSPORT, THEY SHOVED IT IN A BAG, BUT IT WAS STRAIGHT WHEN IT WAS REMOVED FROM THE PATIENT. ABOUT 1¿ OF THE CASING HAS NO MAGNETS IN IT. ABOUT .8¿ OF THE CASING IS MISSING. IF THERE ARE 21 MAGNETS IN EACH WIRE, 12 ARE NOT ACCOUNTED FOR. PATIENT INFO: COMORBIDITIES: TRIPLE A AORTIC MITRALTIS, AORTIC ROOT DISSECTION, ASTHMA, PNEUMONIA, GERD, MELANOMA, AORTIC ROOT AND HEMIAORTIC ARCH REPLACEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670751 ↗
• MalfunctionMar 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "CK000409A, POWERPICC SOLO 4 FRENCH PROVENA DUAL, KINKING ISSUE. PLACE ON 2/1, PATIENT OBESE. THEY RETHREADED WITH A 5 FRENCH DUAL IN IR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11421866 ↗
• MalfunctionFeb 25, 2021Material Twisted/Bent; No Flow

  IT WAS REPORTED "PLACED ON 1/26 CK000409A 4 FRENCH DUAL LUMEN POWERPICC PROVENA SOLO, THE NEXT DAY NO BLOOD RETURN, XRAY TAKEN OF ARM AND KINK FOUND. "

  Patient problems: Insufficient Information

  MAUDE report 11379883 ↗
• MalfunctionFeb 19, 2021Material Deformation; Difficult to Flush; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED "PICC PLACED ON 12/20 EXTERNAL 2 CM. RIGHT BRACHIAL PLACEMENT. 12/27 ISSUES WITH BLOOD RETURN/FLUSHING BUT COULD BE FIXED POSITIONALLY. 12/28 PICC WAS KINKING FOUND WITH XRAY, WAS RETHREADED BY IR, THEY DID NOT RE-ACCESS THROUGH A NEW HOLE. 1/1 TPA USED AND PULLED BACK, NO BLOOD RETURN STILL. 1/7 IT WAS REMOVED BECAUSE THEY WERE STILL HAVING ISSUES."

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

  MAUDE report 11348767 ↗