PowerPICC Catheter 3174155Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741027611), received between Jun 23, 2017 and Nov 26, 2024 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. Mar 11, 2025Class IOpen, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THE CLIENT OPENED A PICC CATHETER KIT REF. 3174155, FOR INTERNAL ANALYSIS AND DEMONSTRATION. THIS KIT DID NOT COME INTO CONTACT WITH ANY PATIENT. WHEN HANDLING THE DEVICE, IT WAS OBSERVED THAT THE STYLET BROKE WHEN TRACTION WAS APPLIED, GENERATING FINE FRAGMENTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785045 ↗
• InjuryNov 22, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER, PICC INSERTION NURSE CONTACTED INFORMING THAT 24 HOURS AFTER CATHETER INSERTION, IMAGE SHOWED THAT PART OF THE GUIDE WIRE WAS IN THE PULMONARY ARTERY. PATIENT HAD TO UNDERGO HEMODYNAMIC PROCEDURE TO REMOVE FOREIGN BODY. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 30, 2024: IT WAS REPORTED THE FRAGMENT REMOVED FROM THE PEDIATRIC PATIENT¿S PULMONARY ARTERY. PHYSICAL HARM DUE TO AN INVASIVE MEDICAL PROCEDURE. IMPACT ON HEALTH DUE TO THE NEED FOR INTERVENTION AND DIAGNOSIS OF THROMBOSIS. IN ADDITION TO EXTENDING THE PERIOD OF HOSPITALIZATION. AFTER INSERTING THE PICC, THE PATIENT PRESENTED SYMPTOMS OF DYSPNEA. AN X-RAY WAS REQUESTED AND A FOREIGN BODY WAS IDENTIFIED IN THE CHEST REGION. THE CATHETER STYLET BROKE AND A FRAGMENT LODGED IN THE PULMONARY ARTERY, REQUIRING CATHETERIZATION INTERVENTION IN HEMODYNAMICS TO REMOVE IT. A FEW HOURS AFTER THE PROCEDURE, A THROMBUS WAS DIAGNOSED IN THE PULMONARY ARTERY, REQUIRING THE PATIENT TO BE TREATED WITH ANTICOAGULATION. THE PATIENT REMAINS HOSPITALIZED, UNDER OBSERVATION, USING THE INSERTED CATHETER WITH CONTINUOUS MEDICATION TO TREAT THE THROMBUS. THE PICC RADIOLOGY WAS INSERTED ON (B)(6) 2024, PERFORMED BY A

  Patient problems: Dyspnea; Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 20760296 ↗
• MalfunctionAug 14, 2023Component Incompatible; Material Deformation; Component Incompatible; Material Deformation

  IT WAS REPORTED THE DEVICE PRESENTS DIFFICULTY TO USE THE GUIDEWIRE. DELAY IN PROCEDURE. ADDITIONAL INFORMATION RECEIVED 04 AUGUST 2023: INITIALLY, IT WAS NOTED THAT THE GUIDEWIRE OF THE 4FR SINGLE LUMEN KIT WAS DIFFERENT FROM THE OTHERS USED. THE PUNCTURE WAS PERFORMED, BUT THE GUIDEWIRE FAILED TO ADVANCE, AS IT WAS NOTED A DIFFICULT TO SLIDE IT. UPON REMOVAL IT GOT OFF COMPLETELY TORTUOUS. IT WAS PUNCTURED ONCE AGAIN, BUT WITH THE GUIDEWIRE DAMAGED THERE WAS NO PROGRESSION, MAKING IMPOSSIBLE TO USE IT. A NEW CATHETER WAS TAKEN AND I USED THE GUIDEWIRE FROM A 3FR KIT IN THE 4FR CATHETER, PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER THIS EXCHANGE. ADDITIONAL PUNCTURES NEEDED. PATIENT GOT DISCHARGED. NO MEDICAL INTERVENTION WAS NEEDED. IT WAS A PEDIATRIC PATIENT BEING TREATED WITH CHEMOTHERAPY. THERE WAS NOT A BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541741 ↗
• InjuryMar 6, 2023Break; Break

  CUSTOMER REPORTED THAT THE DEVICE WAS PULLED OUT ACCORDING TO PROTOCOL WITHOUT RESISTANCE, DURING THE COURSE IT WAS PULLED OUT 38 CM AS INSERTED, BUT IT WAS NOTICED THAT THE TIP WAS BROKEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16492968 ↗
• MalfunctionJan 25, 2023Material Deformation; Material Deformation

  IT WAS REPORTED DURING PASSAGE OF CATHETER, THE DILATOR DIDN'T PROGRESS. IT WAS IDENTIFIED THAT IT'S DAMAGED, WITHOUT BEING SHARP ENOUGH FOR PROGRESSION. IT WAS NEEDED TO OPEN A NEW DEVICE THAT WAS USED WITHOUT ANY DIFFICULTIES. ADDITIONAL INFORMATION RECEIVED ON 02/01/2023: THERE WAS NO HARM TO THE PATIENT, AND NO MEDICAL INTERVENTION WAS NEEDED. THE RIGHT BASILICA VEIN WAS ACCESSED, THE TARGET SITE WAS THE THIRD INTERCOSTAL SPACE. PATIENT IS BEING TREATED WITH DOCETAXEL/GENCITABIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244533 ↗
• MalfunctionOct 31, 2022Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "THE PICC CLAMP SNAPPED WHEN CLAMPING AFTER FLUSHING THE LINE. THIS WAS FOR A HOMECARE PATIENT USING AN ELASTOMERIC PUMP DURING HOME INFUSION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698740 ↗
• MalfunctionOct 31, 2022Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "THE PICC CLAMP SNAPPED WHEN CLAMPING AFTER FLUSHING THE LINE. THIS WAS FOR A HOMECARE PATIENT USING AN ELASTOMERIC PUMP DURING HOME INFUSION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698739 ↗
• MalfunctionOct 31, 2022Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "THE PICC CLAMP SNAPPED WHEN CLAMPING AFTER FLUSHING THE LINE. THIS WAS FOR A HOMECARE PATIENT USING AN ELASTOMERIC PUMP DURING HOME INFUSION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698738 ↗
• MalfunctionOct 31, 2022Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "THE PICC CLAMP SNAPPED WHEN CLAMPING AFTER FLUSHING THE LINE. THIS WAS FOR A HOMECARE PATIENT USING AN ELASTOMERIC PUMP DURING HOME INFUSION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698649 ↗
• MalfunctionJul 19, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED "PULLED OUT ACCORDING TO PROTOCOL WITHOUT RESISTANCE, DURING THE COURSE IT WAS PULLED OUT 38 CM AS INSERTED, BUT IT WAS NOTICED THAT THE TIP WAS BROKEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15054236 ↗
• InjuryMar 11, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT THERE WAS NO PROGRESSION OF THE GUIDE WIRE AFTER INTRODUCTION APPROXIMATELY 15 CM, IN WITHDRAWAL, GUIDE WIRE PRESENTS RESISTANCE AFTER APPROXIMATELY 5 CM, IT WAS REINTRODUCED AND PULLED TWICE, WITH MOVEMENT OF THE LIMB ANGLE, IN THE THIRD ATTEMPT THE WIRE SLIDES EASILY, HOWEVER THE NOTIFIER OBSERVES AND "FEELS" THE OPENING OF THE FILAMENT AND NEW RESISTANCE, PAUSE REMOVED AND OBSERVE THE OPENING OF THE WIRE (PEELED APPROXIMATELY 1.5 CM). ADDITIONAL INFORMATION RECEIVED: WAS THERE ANY HARM TO THE PATIENT/HEALTH WORKER? UNINFORMED WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE EVENT (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC)? IT WAS NECESSARY TO INTERVENE BY A VASCULAR PHYSICIAN TO REMOVE THE GUIDE WIRE. AND NON-CONTRAST CT AND RX WERE PERFORMED TO EXCLUDE FOREIGN BODY HAS THERE BEEN BLOOD OR CHEMOTHERAPY EXPOSURE TO MUCOUS MEMBRANES OR SKIN? (DETAIL) NO BLOOD WAS REPORTED AND THE PATIENT HAD NOT USED CHEMOTHERAPY UNTIL THAT MOMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13737647 ↗
• MalfunctionMar 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT UNDERWENT AN X-RAY OF THE RIGHT ARM AND CHEST FOR EVALUATION AFTER COMPLAINT OF PAIN IN THE INSERTION SITE WHEN SANITIZING THE PICC, WHICH ACCORDING TO HIM OCCURS SINCE THE DAY OF INSERTION AND AFTER AN UNSUCCESSFUL ATTEMPT TO REMOVE THE CATHETER. X-RAY SHOWS PARTIAL RUPTURE OF THE CATHETER NEAR BY THE INSERTION SITE. ON (B)(6) 2021, IT WAS REPORTED TO THE HOSPITAL'S PHARMACY THAT, ON (B)(6) 2021, THE PROFESSIONAL WAS INFORMED ABOUT THE OBSTRUCTION OF THE PICC CATHETER OF PATIENT. UPON ARRIVING TO HIS BED, ABOUT AT 9:00 AM, THE PATIENT REPORTED THAT HE WAS FEELING PAIN IN THE PERI-INSERTION REGION. IT WAS PERFORMED AN INSPECTION OF THE ACCESS SITE, NO CHANGES OBSERVED; IT WAS PERFORMED AN ATTEMPT OF CLEARING BY FLUSHING WITH SALINE SOLUTION WITH A 10ML SYRINGE, BUT WITHOUT SUCCESS; CLEARING WAS DONE WITH THE "TAP" TECHNIQUE AND HEPARIN SOLUTION, ACCORDING TO THE PROTOCOL, AND SUCCESS WAS ACHIEVED. AFTER CLEARING, IT WAS VISUALIZED THE CATHETER, WHICH WAS IN AD (RIGHT ATRIUM), ALONG WITH THE NURSE, AND AGREED TO PULL 02 CM OF THE CATHETER. THE HEALTH PROFESSIONAL EMPHASIZES THAT THE PATIENT INFORMS THAT HE HAS BEEN IN PAIN SINCE THE INSERTION OF THE CATHETER

  Patient problems: Pain

  MAUDE report 11536702 ↗
• MalfunctionJan 15, 2021Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT IN THE THIRD CYCLE OF ALINTA AND CARBOPLATIN BY PICC IN UPPER RIGHT LIMB TODAY. AT THE END OF THE ADMINISTRATION AT THE MOMENT OF SALINE FLUSHING, SHE REPORTED FEELING COLD, PAINLESS AND OBSERVED FLUID OUTFLOW FROM THE CATHETER OSTIUM AND BULGING 4 CM FROM THE INSERTION AS SHOWN IN THE PHOTO. THE CATHETER WAS REMOVED AND THE MEASUREMENT WAS PERFORMED ACCORDING TO THE PASSAGE ON 11/05 (CATHETER 37CM), ARM CIRCUMFERENCE IDENTICAL TO 11/05 (27CM). DRENISSON PREVENTIVE TOPIC INTRODUCED, MEDICAL TEAM COMMUNICATION. NOTE: INSERTION OCCURRED WITHOUT DIFFICULTY ON 11/05; PREVIOUS APPLICATIONS WITHOUT COMPLAINTS EVEN THROUGH FLUSHING. WEEKLY DRESSINGS WITHOUT COMPLICATIONS OR ANY OTHER SIGN, BRACHIAL CIRCUMFERENCE MAINTAINED. AS A CONSEQUENCE, THE PICC CATHETER HAD TO BE REMOVED BEFORE THE SCHEDULED DATE AND THERE IS STILL AN APPLICATION TO FINISH THE SERVICE. AFTER ACCESS ANALYSIS, THE LAST APPLICATION WILL BE BY PERIPHERAL VEIN.

  Patient problems: Chemical Exposure; Extravasation

  MAUDE report 11180953 ↗
• MalfunctionOct 23, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC LEAKED WHILE USED ON AN ONCOLOGY PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731342 ↗
• MalfunctionSep 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTION SEEMS TO HAVE SOMETHING BLOCKING THE THREADS OF THE LUER CONNECTION. THE NEEDLE-FREE CONNECTOR (NFC) THAT WAS BEING LUERED ONTO THE PICC IS A BAXTER ONE-LINK. IT WAS STATED WHEN THEY ASPIRATED THE PICC, THERE WERE VISIBLE AIR BUBBLES. WHEN THE PICC HAD BEEN FLUSHED, THERE WAS AND A LEAK COMING FROM THE CONNECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10491607 ↗
• MalfunctionSep 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTION SEEMS TO HAVE SOMETHING BLOCKING THE THREADS OF THE LUER CONNECTION. THE NEEDLE-FREE CONNECTOR (NFC) THAT WAS BEING LUERED ONTO THE PICC IS A BAXTER ONE-LINK. WHEN THEY ASPIRATED THE PICC, THERE WERE VISIBLE AIR BUBBLES. WHEN THE PICC HAD BEEN FLUSHED, THERE WAS AND A LEAK COMING FROM THE CONNECTION. THE REPORTER CAME TO THE CONCLUSION THAT THERE IS SOMETHING WRONG WITH THE THREADS OF THE PICC THAT IS CAUSING AN INTERFERENCE OF A CLOSED LUERED CONNECTION. IT WAS FURTHER REPORTED THAT WHEN THIS OCCURRENCE HAD HAPPENED, THEY SWITCHED THE PATIENT¿S BARD PICC OUT FOR AN ANGIODYNAMICS PICC AND USED THE EXACT SAME BAXTER ONE-LINK NFC THAT HAD BEEN USED ON THE BARD PICC AND THEN HAD NO LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10491606 ↗
• MalfunctionSep 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED ON AUGUST 14TH, LEAKAGE AT THE CONNECTION OCCURRED DURING A CHEMOTHERAPY TREATMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10491423 ↗
• MalfunctionAug 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PICC WAS PLACED ON 7/23, REF # 3174155, LOT REEQ0588 FOR A PATIENT REQUIRING TPN AND SECURED WITH SUTURES. IT WAS DISCOVERED THAT THE LUER LOCK HUB WAS LEAKING ON 7/24 AND THE PATIENT HAD A PICC LINE EXCHANGE DONE WITH A DIFFERENT LOT NUMBER. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10434881 ↗
• MalfunctionAug 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTION SEEMS TO HAVE SOMETHING BLOCKING THE THREADS OF THE LUER CONNECTION. THE NEEDLE-FREE CONNECTOR (NFC) THAT WAS BEING LUERED ONTO THE PICC IS A BAXTER ONE-LINK. WHEN THE STAFF ASPIRATED THE PICC, THERE WERE VISIBLE AIR BUBBLES. WHEN THE PICC HAD BEEN FLUSHED, THERE WAS A LEAK COMING FROM THE CONNECTION. THE REPORTER CAME TO THE CONCLUSION THAT THERE IS SOMETHING WRONG WITH THE THREADS OF THE PICC THAT IS CAUSING AN INTERFERENCE OF A CLOSED LUERED CONNECTION. IT WAS FURTHER REPORTED THAT WHEN THE 3RD OCCURRENCE HAD HAPPENED, THEY SWITCHED THE PATIENT¿S BARD PICC OUT FOR AN ANGIODYNAMICS PICC AND USED THE EXACT SAME BAXTER ONE-LINK NFC THAT HAD BEEN USED ON THE BARD PICC AND HAD NO LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10434597 ↗
• MalfunctionAug 1, 2019Contamination /Decontamination Problem

  IT WAS REPORTED DIRT FOUND OVER PRODUCT AND THROUGHOUT BOX. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8851662 ↗
• InjuryMay 2, 2019Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2018,THERE WAS AN ATTEMPT TO PASS PICC CATHETER UNSUCCESSFULLY. ACCORDING TO THE REPORT, THERE WAS A "CERTAIN" RESISTANCE IN THE PROGRESSION OF THE GUIDEWIRE THAT NEEDED TO BE DRAWN FOR A NEW PUNCTURE ATTEMPT. WHEN PULLING THE GUIDEWIRE, RESISTANCE PERSISTED UNTIL IT WAS REMOVED. ON (B)(6) 2019: ADDITIONAL INFORMATION RECEIVED: THE NURSES WHO PERFORMED THE PROCEDURE REPORTED HAVING HAD NO DIFFICULTY IN INTRODUCING AND REMOVING THE GUIDEWIRE. THE CATHETER INSERTED HAD A LENGTH OF 10 CM AND WAS REMOVED AT 10 CM. NO RUPTURE OF THE CATHETER WAS OBSERVED. THE EVENT WAS CHARACTERIZED AS EVENT WITH SEVERE DAMAGE, REQUIRING FOLLOW-UP WITH A CARDIOLOGIST FOR 1 YEAR TO PERFORM ECHOCARDIOGRAM AND CHEST X-RAY EVERY 3 MONTHS. IN DISCUSSION WITH THE MULTIDISCIPLINARY TEAM WILL NOT BE APPROACHED SURGICALLY DUE TO RISK TO THE PATIENT. FOLLOWED UP TO OBSERVE IF THE FRAGMENT IS MOVING AND IF THERE IS HEMODYNAMIC REPERCUSSION. ON (B)(6) 2019 - THE REPORTING HEALTH PROFESSIONAL REPORTS THERE IS A FRAGMENT IN THE PATIENT WHICH IS "PROBABLY" A PIECE OF GUIDEWIRE. THE FRAGMENT WILL NOT BE REMOVED DUE TO THE HIGH RISK OF THE PROCEDURE. THE PATIENT WILL BE FOLLOWED UP TO OBSE

  Patient problems: Foreign Body In Patient

  MAUDE report 8574770 ↗
• MalfunctionMay 16, 2018Coiled

  IT WAS REPORTED THAT THE GUIDEWIRE PRESENTED AT ITS TIP A COILING FROM THE FIRST MOMENT OF THE INTRODUCTION, IT WAS STATED THE WIRE IS LARGER, THICKER AND THE TIP IS "DANGEROUS". ON (B)(6) 2018 THE GUIDEWIRE WAS REPORTEDLY "WRAPPED" AND "WINDING".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7520549 ↗
• MalfunctionDec 14, 2017Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT'S MOTHER THAT HER DAUGHTER WAS HAVING AN ALLERGIC REACTION TO HER "PURPLE DUAL LUMEN POWERPICC" AND IS INQUIRING ABOUT THE MATERIALS USED TO MANUFACTURER THE DEVICE.

  Patient problems: Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7117033 ↗
• MalfunctionNov 30, 2017Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT "DRILLING" WAS DETECTED IN THE MATERIAL CAUSING LEAKAGE. NO OTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 7070698 ↗
• MalfunctionSep 6, 2017Physical Resistance; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE GUIDEWIRE WAS PASSED AFTER THE PUNCTURE, THERE WAS RESISTANCE IN THE PASSAGE OF THE GUIDEWIRE, AND WHEN THE GUIDEWIRE WAS REMOVED, IT WAS TWISTED, AND THERE WERE NO NEW PASS CONDITIONS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6844575 ↗