PowerPICC SV Catheter 1173108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741087103), received between May 17, 2016 and Jul 12, 2023 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A LONG BLACK HAIR IN A KIT LAST WEEK. THEY JUST OPENED THE PACK AND IMMEDIATELY SAW IT. THEY DIDN'T USE THE KIT. ADDITIONAL INFORMATION FROM CUSTOMER RESPONSE ON 06-30-2023 NO PATIENT HARM OR URGENT SITUATION, JUST USED A NEW KIT. THERE WAS A VERY BRIEF DELAY IN GETTING A NEW KIT. WE ONLY CARRY ONE OF EACH SIZE ON OUR CART SO THERE WAS A BRIEF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313079 ↗
• MalfunctionJan 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "TODAY ON A PEDIATRIC PATIENT, A LEAK WAS NOTED DURING DRESSING CHANGE. AT THIS TIME, THE LINE REMAINS IN A FEMORAL LOCATION, OTHERWISE WORKING APPROPRIATELY." ADDITIONAL INFORMATION RECEIVED 1/24/2023: IT WAS REPORTED BY THE CUSTOMER "THE PICC ((B)(6) 2022) IS STILL IN THE PATIENT'S LEFT FEMORAL (WE WERE UNABLE TO PROVIDE A REPLACEMENT TODAY), CUT 18 CM, 45% OCCLUSION. NO HARM HAS BEEN REPORTED. THE SITE DRESSED WITH SMALL GAUZE OVER THE TRANSITION HUB UNDER TEGADERM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247316 ↗
• MalfunctionJan 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER " I PLACED A 3FR POWER PICC IN LUE OF PEDIATRIC PATIENT ON (B)(6) 2022 WHICH WAS SUBSEQUENTLY REMOVED ON (B)(6) 2022 BECAUSE OF A LEAK AT THE WING/HUB, PURPLE SIDE. THIS WAS ¿NOTED DURING DRESSING CHANGE¿, PER RN REPORT AT THAT TIME." ADD INFO RECEIVED 01/24/2023 - THE FIRST LINE WAS PLACED ON (B)(6) 2022 IN PATIENT, IN THE LEFT BASILIC, CUT 11 CM, OUT 0.5 CM, 40% OCCLUSION, EXPLANT ON (B)(6) 2022. WE HAVE IN A BIO BAG. NO PATIENT HARM HAS BEEN REPORTED. THE SITE IS DRESSED W/SMALL GAUZE OVER THE TRANSITION HUB, UNDER THE TEGADERM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233430 ↗
• MalfunctionDec 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "FLUID LEAKING WHERE LINE JOINS SECUREMENT (STATLOCK)". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16071066 ↗
• MalfunctionNov 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "THE LINE HAD A CRACKED HUB THAT STARTED TO LEAK." ADDITIONAL INFORMATION PROVIDED: EVENT INFORMATION :A DETAILED DESCRIPTION OF THE EVENT: LINE WAS PLACED 9/25 AND FOUND ON (B)(6) 2022 LEAKING AND WAS CRACKED AT THE HUB. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STATLOCK DATE OF OCCURRENCE: (B)(6) 2022. PLACEMENT DATE: (B)(6) 2022. EXPLANT DATE: (B)(6) 2022. PATIENT INFORMATION (IF AVAILABLE) WAS THE PRODUCT USED ON A PATIENT? YES. WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. PATIENT REQUIRED TO GO TO OR TO GET SEDATED AS WAS NOT ABLE TO COMPLETE PROCEDURE AT BEDSIDE AND REQUIRE MORE SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756845 ↗
• MalfunctionFeb 16, 2022Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "3F PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WIRE DISCOVERED TO BE BROKEN AFTER PICC INSERTION WAS COMPLETE." ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 WAS THERE ANY PATIENT HARM REPORTED? NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546044 ↗
• MalfunctionOct 29, 2020Break; Leak/Splash

  IT WAS REPORTED "PICC HAVE SPLIT AT THE HUB OF THE LUMEN CAUSING THE FLUID PATHWAY TO OPEN AND ALLOW AIR AND LEAKAGE." CATHETER WAS INSERTED ON (B)(6) 2020 AND IT HAD BROKEN BY (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10759337 ↗
• MalfunctionOct 29, 2020Break; Leak/Splash

  IT WAS REPORTED "PICC HAVE SPLIT AT THE HUB OF THE LUMEN CAUSING THE FLUID PATHWAY TO OPEN AND ALLOW AIR AND LEAKAGE." CATHETER WAS INSERTED ON (B)(6) 2020 AND IT HAD BROKEN BY (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10759206 ↗
• MalfunctionDec 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC LINE IS LEAKING AT THE 1 CM MARK. ON 12/4/2019: NURSE STATED "THERE WAS NO HARM TO THE PATIENT, BUT THEY WENT TO THE OR SPECIFICALLY FOR PICC PLACEMENT, WITH A NEW PIV BEING PLACED TODAY TO TAKE PICC OUT. PATIENT HAD ECOLI UTI AND WAS PLACED FOR 2 WEEKS ANTIBIOTICS. "

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9512975 ↗
• MalfunctionOct 22, 2019Data Problem; Data Problem

  IT WAS REPORTED VIA MEDWATCH, "PT UNDERWENT A PICC LINE PLACEMENT UTILIZING BARD 3CG+ TECHNOLOGY. DURING PLACEMENT, 3CG+ TECHNOLOGY INDICATED A 23CM PICC WAS TOO SHORT AND EXHCNAGED PICC INTRA PROCEDURE TO A 26CM PICC; 3CG+ CONFIRMED PLACEMENT AT 26CM WITH 1CM OUT FORM INSERTION SITE. CHEST X-RAY IN CONJUNCTION WITH 3CG+ TECHNOLOGY. PICC LINE 2CM TOO DEEP IN RIGHT ATRIUM. SECOND KIT WAS CHARGED TO PT DUE TO ERROR IN 3CG TECHNOLOGY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9219668 ↗
• MalfunctionJun 21, 2019Fracture

  IT WAS REPORTED THAT PICC WAS FOUND TO BE FRACTURED WHEN FLUSHING. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724315 ↗
• MalfunctionJun 21, 2019Deformation Due to Compressive Stress; Material Protrusion/Extrusion

  IT WAS REPORTED VIA MEDWATCH, "[RN] WAS INSERTING A PERIPHERALLY INSERTED CENTRAL CATHETER INTO THIS PATIENT. THE MICROEZ MICROINTRODUCER, 3.5 FR WITH VESSEL DILATOR WAS NOT ABLE TO PENETRATE THE SKIN EVEN WITH 8-10 ATTEMPTS AND A LARGE AMOUNT OF DOWNWARD PUSHING. WHEN [THE RN] ASKED THE CIRCULATING NURSE TO OPEN A NEW 3.5 FR MICROEZ MICROINTRODUCER KIT [THE RN] NOTICED THAT THE PEEL-AWAY SHEATH HAD A PROTRUDING RING AROUND IT ABOUT 1/4" FROM THE END. AFTER THE DEVICE WAS OUT OF THE PATIENT [THE RN] EXAMINED THE END OF IT AND SAW THE END OF THE PEEL-AWAY SHEATH WAS UNEVEN AND WRINKLED. WHEN [THE RN] USED THE NEW MICROEZ MICROINTRODUCER THERE WAS NO DIFFICULTY WITH INSERTION".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8723743 ↗
• InjuryFeb 26, 2019Crack

  IT WAS REPORTED THAT THE PURPLE HUB OF THE PICC WAS NOTED TO BE CRACKED AND WAS REMOVED. PATIENT REQUIRED HOSPITALIZATION AS ANOTHER PICC LINE WAS UNABLE TO BE IMMEDIATELY PLACED.

  Patient problems: No Code Available

  MAUDE report 8371165 ↗
• MalfunctionMay 17, 2016Signal Artifact/Noise; Break; Difficult to Remove; Physical Resistance

  ON (B)(6) 2016 FACILITY CONTACT REPORTED THAT A (B)(6) OLD PATIENT HAD A PICC LINE INSERTION DONE UNDER SEDATION AFTER BEING ADMITTED FOR CO ABDOMINAL PAIN, DIARRHEA, AND INTOLERANCE OF GASTROSTOMY TUBES. NURSES REPORTED THAT THEY FELT RESISTANCE AND HAD DIFFICULTY REMOVING THE INTERNAL WIRE AFTER THE PICC LINE WAS PLACED. THEY STATED THAT THE DISTAL TIP SHEARED OFF THE INTERNAL WIRE. A POST PROCEDURE X-RAY SHOWED AN ARTIFACT AT THE LEVEL OF THE RIGHT SUBCLAVIAN VEIN. X-RAY WAS REPEATED AFTER PICC LINE WAS PULLED BACK, AND THE ARTIFACT THAT WAS PREVIOUSLY NOTED REMAINED IN PLACE.

  Patient problems: No Information

  MAUDE report 5660986 ↗