PowerPICC SV Catheter 1274108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741087110), received between Apr 11, 2017 and Feb 3, 2026 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2659-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PEN WAS FOUND INSIDE THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251889 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS NOTED TO BE LEAKING FROM THE RED LUMEN AND THE TEAM IDENTIFIED A HOLE IN THE CATHETER. PICC EXCHANGE WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958392 ↗
• MalfunctionFeb 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, KINKED PICC. CATHETER PLACED (B)(6) 2024 IN BASILIC VEIN. CATHETER LENGTH: 40CM, 0CM EXIT SITE MARKINGS. STATLOCK USED. KINK NOTED AT 30CM MARK. DWELL TIME: 5 DAYS. GENERAL LOCATION: SUBCLAVIAN REGION. CATHETER EXCHANGED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317144 ↗
• MalfunctionFeb 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, KINKED PICC. CATHETER PLACED (B)(6)2024 IN BRACHIAL VEIN. CATHETER LENGTH: 34CM, 3CM EXIT SITE MARKINGS. STATLOCK USED. KINK NOTED AT 12CM MARK. GENERAL LOCATION: AXILLARY REGION. CATHETER PULLED BACK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317095 ↗
• MalfunctionJan 20, 2025Material Deformation; Material Deformation

  PICC WAS INSERTED ON (B)(6) 2024 IN THE RIGHT BRACHIAL VEIN WITH A TOTAL CATHETER LENGTH OF 37 CM AND 0 CM LEFT EXTERNAL. CATHETER SECURED WITH STATLOCK. KINK WAS DISCOVERED IN THE INNOMINATE REGION 6 DAYS AFTER INSERTION. CATHETER WAS EXCHANGED. CATHETER HAD BEEN TPA'D 1X DURING THE 6-DAY INDWELL PERIOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191457 ↗
• MalfunctionJan 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC WAS PLACED ON (B)(6) 2024 MEASURING AT 45 CM WITH 1 CM VISIBLE SECUREACATH DEVICE WAS USED TO SECURE THE PICC IN PLACE. ON (B)(6) 2024 THE PICC WAS FOUND TO BE LEAKING PICC AND WAS REMOVED, A NEW PICC PLACEMENT WAS ATTEMPTED BUT FAILED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125518 ↗
• MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC WAS PLACED ON (B)(6) 2024 MEASURING AT 39 CM WITH 3CM VISIBLE WITH SECUREMENT DEVICE USED TO KEEP THE PICC IN PLACE. ON (B)(6) 2024 THE PICC WAS FOUND TO BE LEAKING AT THE 2 CM MARK. PICC WAS REMOVED, WITH NEW PICC PLACED ON (B)(6) 2024. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120808 ↗
• MalfunctionJan 4, 2025Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT 2 PICCS KINKED. ONE PATIENT HAD THEIR PICC EXCHANGED, AND THE OTHER PATIENT WAS SENT FOR IR REFERRAL. PICC DWELL TIMES WERE 4 DAYS AND 22 DAYS. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075631 ↗
• MalfunctionOct 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT PICC WAS LEAKING FROM HOLE IN LINE. NEW PICC HAD TO BE PLACED. IT IS A PEDIATRIC PATIENT SO THE PATIENT HAD TO BE PUT UNDER SEDATION AGAIN FOR THIS TO BE DONE. NO OTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965158 ↗
• MalfunctionMay 12, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER, "A 4FR DL POWERPICC PROVENA INSERTED IN THE RIGHT UPPER ARM BRACHIAL VEIN ON (B)(6) 2022 WAS FOUND TO BE KINKED ON (B)(6) 2022 IN THE SUBCLAVIAN REGION. PICC DWELL TIME WAS 14 DAYS. PICC WAS EXCHANGED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924394 ↗
• MalfunctionJan 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "EXPERIENCED LEAKAGE FROM THE WHITE PORT OF THE PICC." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102640 ↗
• MalfunctionJan 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, "EXPERIENCED LEAKAGE FROM THE WHITE PORT OF THE PICC." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102368 ↗
• MalfunctionDec 14, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "STYLET BENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002736 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MS&S "CALLER STATES A PATIENT HAD A REACTION TO THE HICKMAN CVC, 0600580. CALLER STATES THERE WAS WEEPING DRAINAGE AT THE SITE FROM THIS DEVICE. CALLER STATES THE PATIENT HAD A SIMILAR REACTION TO PICC LINE WITH LOT NUMBER REES3172 (POWERPICC SV 1274108DNS). CALLER ASKING FOR THE MATERIALS OF THESE DEVICES AND IF THEY ARE SIMILAR." MS&S RESPONDED "THE HICKMAN CVC 0600580 IS SILICONE. THE PICC LINE 1274108DNS IS POLYURETHANE. EXPLAINED THAT OFTEN PATIENTS CAN HAVE REACTIONS TO DRESSINGS PLACED AT THE INSERTION SITE OR SITE CLEANING MATERIALS LIKE CHLORHEXIDINE, POVIDONE IODINE, ADHESIVE, ETC. DISCUSSED HAVING THE PATIENT TESTED BY ALLERGIST FOR SENSITIVITIES. THIS REPORT ADDRESSES THE REACTION TO THE POWERPICC SV.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11281098 ↗
• MalfunctionDec 23, 2020Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED PICC LINE PLACED AND LEAKING NOTED NEAR TEAR WHEN FLUSHING. THE LINE WAS REMOVED AND REPLACED WITH A NEW ONE. IT WAS REPORTED THIS EVENT OCCURRED TWICE. THIS REPORT ADDRESSES THE SECOND EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11061789 ↗
• MalfunctionDec 23, 2020Leak/Splash

  IT WAS REPORTED PICC LINE PLACED AND LEAKING NOTED NEAR TEAR WHEN FLUSHING. THE LINE WAS REMOVED AND REPLACED WITH A NEW ONE. IT WAS REPORTED THIS EVENT OCCURRED TWICE. THIS REPORT ADDRESSES THE FIRST EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11061785 ↗
• MalfunctionDec 22, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation

  IT WAS REPORTED DEFECTIVE GUIDE-WIRE OR 4.5F INTRODUCER, STUCK UPON INSERTION AND ATTEMPT TO WITHDRAWAL. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 11060917 ↗
• MalfunctionDec 22, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation

  IT WAS REPORTED THE LINE WAS STUCK UPON INSERTION AND WITHDRAWAL AND SURGEON HAD TO REMOVE. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 11060907 ↗
• MalfunctionNov 23, 2020Fluid/Blood Leak; Material Puncture/Hole; Material Twisted/Bent

  IT WAS REPORTED "WRITER CALLED TO ASSESS PICC LINE THIS MORNING. RN STATED THAT WHEN DISTAL PORT OF PICC LINE WAS FLUSHED THAT BIOPATCH AND DRESSING BECAME SATURATED. WRITER ASSESSED LINE AND AGREED WITH ASSESSMENT. WRITER AND RN SPOKE WITH COVERING TEAM AND DECISION WAS MADE TO D/C PICC AND SEE HOW PATIENT WOULD DO. PIV PLACED FOR ANTIBIOTICS AND PICC LINE D/C'D. WHEN PICC REMOVED THERE WAS A TWIST IN THE CATHETER AND VISIBLE HOLE IN DISTAL PORTION OF PICC LINE. PATIENT SCHEDULED FOR SEDATION ON THURSDAY MORNING IN CASE PICC LINE NEEDS TO BE REPLACED." DID EVENT OCCUR DURING PLACEMENT, DURING REMOVAL, OR AFTER REMOVAL? "WHILE IN-DWELLING".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10886540 ↗
• MalfunctionAug 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE POWERPICC SV HAD A HOLE ON THE CATHETER AT THE PROXIMAL END WHERE IT CONNECTS TO THE STIFF SUTURE WING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437255 ↗
• MalfunctionAug 21, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THERE WAS A KINK NEAR THE ¿0¿ MARK BUT NO HOLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10437218 ↗
• MalfunctionJun 13, 2019Fracture

  IT WAS REPORTED THAT AFTER REMOVING THE 3CG STYLET FROM THE PICC LINE IT WAS NOTED THAT THE STYLET WIRE WAS FRACTURED TOWARDS THE END. NO HARM TO PATIENT WAS DONE. INSERTER STATES WIRE WAS NOT CUT DURING PICC TRIMMING. COMPLAINANT STATES WAS NOT PRESENT AND CANNOT CONFIRM IF IT WAS CUT OR NOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696678 ↗
• MalfunctionJan 8, 2019Leak/Splash

  IT WAS REPORTED THAT A LEAK IN 4FR RED LUMEN WAS OBSERVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8228941 ↗
• MalfunctionDec 19, 2018Leak/Splash; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT WAS READMITTED TO THE HOSPITAL WITH A LEAKING PICC. THE STAFF CONFIRMED THERE WAS A PIN HOLE LEAK DISTAL TO THE INSERTION SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8180204 ↗
• MalfunctionMar 12, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC WAS LEAKING FROM ONE OF THE ACCESS PORTS. A NEW DEVICE WAS PLACED. NO PATIENT INJURY REPORTED, ONLY A DELAY IN CARE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7333007 ↗