PowerPICC® Catheters 1385108QRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741034640), received between Jan 18, 2017 and Feb 24, 2023 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THE PATIENT IS EXPERIENCING THE CATHETER KINKING UNDER THE INSERTION SITE SEVERAL DAYS POST-INSERTION. X-RAYS HAVE CONFIRMED THE KINK. 2/14/2023: ADDITIONAL INFORMATION LINE HAD TO BE REMOVED, KINK WOULD NOT PULL STRAIGHT BUT KEPT RE-KINKING UNDER THE SKIN AT THE 9CM MARK, JUST BELOW THE AXILLA BETWEEN THE INSERTION SITE AND THE ARMPIT. LINE HAD TO BE REPLACED. ADDITIONAL INFORMATION RECEIVED 02/24/2023: "IT WAS REPORTED THAT THE VASCULAR ACCESS TEAM (VAT) CALLED TO ASSESS A TL PICC THAT WAS PLACED ON (B)(6) 2023. THE BEDSIDE RN STATED SHE WAS UNABLE TO FLUSH ONE LUMEN. ONCE AT BEDSIDE, ANOTHER LUMEN BECAME OCCLUDED, FOLLOWED BY THE THIRD. MULTIPLE ATTEMPTS TO FLUSH THE LINE WERE MADE AND THE NEEDLELESS CONNECTORS WERE ALSO CHANGED. ULTRASOUND ASSESSMENT OF THE RIGHT UPPER BASILIC SHOWED AN AREA OF NONCOMPRESSIBILITY FROM THE PICC INSERTION SITE TO THE AXILLA. THIS IS INDICATIVE OF THROMBOSIS. ANOTHER CHEST X-RAY WAS REQUESTED DUE TO POOR QUALITY OF PREVIOUS PICTURES AS WELL AS THE NEED TO CONFIRM THE TIP WAS NOT IN IT'S ORIGINAL LOCATION. THE LINE WAS SUSPECTED TO BE 2-3CM SHORTER. AN X-RAY OF THE RIGHT UPPER ARM WAS ALSO OBTAINED. THE UPPER ARM PICTURE SHOWED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 16439256 ↗
• InjuryJan 14, 2021Break; Entrapment of Device

  IT WAS REPORTED "PICC PLACEMENT WAS WITHOUT OBSTRUCTION, DISCOVERED TIP OF SHERLOCK 3CG STYLET BROKE IN PATIENT 1 DAY LATER." ADDITIONAL INFORMATION RECEIVED 12/28/2020, "THIS DEVICE WAS THROWN AWAY BEFORE THE ISSUE WAS REALIZED. PLEASE SEE THE FOLLOWING DESCRIPTION: WORK UP FOR HYPOXIA REVEALED METALLIC FOREIGN BODY IN LT LUNG ON CXR STILL PRESENT ON CXR 2 WKS LATER CONCERNING FOR TRUE FOREIGN BODY RATHER THAN ARTIFACT. FURTHER INVESTIGATION WITH CT CHEST CONFIRMED METALLIC FOREIGN BODY IN PULMONARY ARTERY THROUGH TO BE A PIECE OF THE GUIDE WIRE THAT GOT SHEARED OFF FROM THE PICC PLACED ON (B)(6). IMAGING PRIOR TO THAT DATE DID NOT DEMONSTRATE THE FOREIGN BODY. UNABLE TO RETRIEVE FOREIGN BODY D/T HIGH RISK OF PROCEDURE."

  Patient problems: Foreign Body In Patient

  MAUDE report 11171435 ↗
• MalfunctionJan 14, 2021Break; Entrapment of Device; Material Frayed; Obstruction of Flow; Material Frayed

  IT WAS REPORTED "OBSTRUCTION OBSERVED, WHEN PICC WAS WITHDRAWN, CLINICIAN NOTED THAT STYLET WAS BROKE AND LODGED IN PICC."

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

  MAUDE report 11171332 ↗
• MalfunctionJan 13, 2021Leak/Splash

  IT WAS REPORTED THAT TWO PICC LINES WERE FOUND LEAKING. THERE WAS NO PATIENT IMPACT, BUT DID NEED ADDITIONAL TESTS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11159055 ↗
• MalfunctionJan 13, 2021Leak/Splash

  IT WAS REPORTED THAT TWO PICC LINES WERE FOUND LEAKING. THERE WAS NO PATIENT IMPACT, BUT DID NEED ADDITIONAL TESTS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11159054 ↗
• MalfunctionJul 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC WAS FOUND LEAKING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10258777 ↗
• MalfunctionJul 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PICC LINE WAS FOUND LEAKING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10258690 ↗
• MalfunctionJul 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THERE WAS A LEAK IN A 3L BARD POWER PICC IN A MICU PATIENT, THE LEAK WAS IN THE WHITE PORT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257637 ↗
• MalfunctionMar 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TRIPLE LUMEN 5 FRENCH WITH 3CG TPS STYLET POWER PICC WAS PLACED ON (B)(6) 2020, IN AN ICU PATIENT. IT WAS STATED TO BE LEAKING DURING FLUSHING OF THE POWER INJECTABLE LUMEN, BENEATH THE SECURACATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9837730 ↗
• InjuryFeb 26, 2020Fluid/Blood Leak; Material Puncture/Hole

  PICC LINE DEVELOPED A LEAK AFTER 3 DAYS. HOLE SEEN IN LINE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9764038 ↗
• MalfunctionFeb 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "LEAKING PICC. HOLE WAS SEEN IN LINE POST-REMOVAL. IT WAS ONLY IN SITU FOR ONE WEEK AND WAS NOT USED FOR POWER INJECTION. A SECURACATH DEVICE WAS USED TO ANCHOR IT IN PLACE" ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH 02/19/2020: "LEAKING PICC. HOLE WAS SEEN IN LINE POST-REMOVAL. IT WAS ONLY IN SITU FOR ONE WEEK AND WAS NOT USED FOR POWER INJECTION. A SECURECATH DEVICE WAS USED TO ANCHOR IT IN PLACE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732436 ↗
• MalfunctionJan 30, 2020Material Frayed; Material Frayed

  THE RN REPORTED THE FOLLOWING, "ATTEMPTING TO PLACE A PICC, UNSUCCESSFUL TO THREAD LINE PASSING SUBCLAVIAN AREA, PICC LINE RETRIEVED AFTER SEVERAL ATTEMPTS MADE WITH NO AVAIL. ONCE LINE WAS RETRIEVED WE NOTICED A SMALL PIECE OF THE WIRE WAS OUT THE TIP OF CATHETER AND WHILE EXAMINING IT REALIZED THERE WAS A SMALL SEGMENT OF THE WIRE THAT WAS CUT OFF THE MAIL WIRE (THE MAGNETIC SIDE)." (B)(6)2020 - ADDITIONAL INFORMATION RECEIVED STATED THERE WAS NO PORTION OF THE WIRE LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649460 ↗
• MalfunctionAug 21, 2019Fluid/Blood Leak; Moisture Damage; Material Puncture/Hole; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PICC DRESSING CHANGE, NURSE FLUSHED WHITE LUMEN WITH SALINE AND NOTICED THE DRESSING WAS SATURATED. A HOLE WAS NOTICED CLOSE TO THE HUB AND THE LINE WAS DC'D IMMEDIATELY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8917680 ↗
• MalfunctionApr 26, 2019Leak/Splash

  IT WAS REPORTED THAT THE PICC LINE WAS PLACED AND STARTED TO LEAK IMMEDIATELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8557768 ↗
• MalfunctionOct 24, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE FACILITY FOUND A HAIR WRAPPED AROUND THE PICC UPON OPENING THE DEVICE. THE DEVICE WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 6974787 ↗
• MalfunctionJan 27, 2017Fluid/Blood Leak; Split

  NURSE AT FACILITY REPORTED THAT A PICC LINE HAD A SPLIT DOWN THE SEAM OF THE CATHETER ON THE GREY PORT. NURSE STATED THAT AFTER THE CATHETER WAS IMPLANTED, THE PATIENT DEVELOPED SEVERE SWELLING IN THEIR ARM. THE PATIENT PREVIOUSLY HAD TWO BREAST AUGMENTATIONS DONE WITH SOME COMPLICATIONS THAT CAUSED HEALTH PROFESSIONALS TO GO THROUGH THE PATIENT'S AXILLARY VEIN. BECAUSE OF THAT HISTORY AND LYMPHEDEMA, THE PICC WAS REMOVED. ONCE REMOVED, THE NURSES FLUSHED THE CATHETER AND FOUND A LEAK WHEN FLUSHING THROUGH THE GREY PORT. NURSE STATED THAT THE LEAK WAS CLOSE TO THE HUB INSIDE THE PATIENT. A NEW PICC WAS PLACED. NO PATIENT HARM REPORTED. NURSE STATED THAT STAFF ARE EDUCATED TO FLUSH WITH 10 CC SYRINGES.

  Patient problems: Swelling

  MAUDE report 6284107 ↗
• MalfunctionJan 18, 2017Fluid/Blood Leak; Moisture Damage

  NURSE AT FACILITY REPORTED THAT DURING CHECKS, ANOTHER NURSE NOTICED THAT THE DRESSING ON A PATIENT WITH A PICC LINE WAS MOIST. WHEN THE NURSE WENT TO CHANGE THE DRESSING, THEY ALSO TRIED FLUSHING THE CATHETER. WHEN FLUSHING THE WHITE PORT, THEY NOTICED FLUID COMING OUT OF THE INSERTION SITE. NURSE STATED THAT THEY THOUGHT THAT THE LEAK WAS COMING FROM THE CATHETER INSIDE THE PATIENT. THE CATHETER WAS REMOVED, NO NEW DEVICE WAS PLACED AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT HARM REPORTED. NURSE STATED THAT THE GREY LUMEN FLUSHED FINE. THEY DID NOT EXAMINE THE PICC LINE AFTER IT WAS REMOVED. NURSE STATED THAT STAFF ARE EDUCATED TO USE A 10CC SYRINGE FOR FLUSHING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6260786 ↗