PowerPICC Provena S3274355Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00801741130052), received between Aug 30, 2017 and Jun 3, 2026 — classified as 3 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT PICC LINE WOULD NOT FLUSH AFTER INSERTED AND THEY DID AN XRAY AND SAW A CRACK IN THE CATHETER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383661 ↗
• MalfunctionJun 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WE HAVE HAD TWO PICCS THAT HAD TO BE REPLACED THIS WEEK THAT WERE LESS THAT 48 HOURS OLD. BOTH OF THEM HAD AN ISSUE WHERE FLUID WAS LEAKING AT THE BASE OF THE RED HUB. ADDITIONAL INFORMATION 05/10/2024: IT WAS REPORTED THE PATIENTS HAD THEIR PICCS REPLACED ON (B)(6) 2024 AND (B)(6) 2024. BOTH PICCS HAD THE SAME LOT NUMBER OF REJP2002.. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446864 ↗
• MalfunctionJun 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WE HAVE HAD TWO PICCS THAT HAD TO BE REPLACED THIS WEEK THAT WERE LESS THAT 48 HOURS OLD. BOTH OF THEM HAD AN ISSUE WHERE FLUID WAS LEAKING AT THE BASE OF THE RED HUB. ADDITIONAL INFORMATION 05/10/2024: IT WAS REPORTED THE PATIENTS HAD THEIR PICCS REPLACED ON (B)(6) 2024 AND (B)(6) 2024. BOTH PICCS HAD THE SAME LOT NUMBER OF REJP2002. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446853 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT HIS FACILITY PLACES THE 4FR DL POWERPICC PROVENA. CALLER STATES HE IS LOOKING TO PLACE THE 3FR POWERPICC PROVENA OR SV BECAUSE THEY HAVE EXPERIENCED A RECENT INCREASE IN PATIENTS EXPERIENCING DEEP VEIN THROMBOSIS. CALLER DESCRIBES INCREASING USE OF THE BRACHIAL VEIN AS IT IS A LARGER VEIN WHEN PLACING PICCS. CALLER STATES THAT A 3FR MAY HELP WITH THIS ISSUE. CALLER ASKING ABOUT THE POWERPLCC SV WITH SHERLOCK AND POWERPICC KITS ENDING IN THE LETTER "P". MS&S DISCUSSED THE DIFFERENCES IN POWERPICC PROVENA VS SV (INTERNAL DIAMETER, FLOW RATES, ETC). DISCUSSED KIT CONTENTS FOR KITS ENDING IN "P". SUGGESTED HE SPEAK TO HIS SALES REP IN THE AREA TO ASSESS WHICH PRODUCTS WOULD WORK BEST FOR THEIR PATIENT POPULATION. EMAILED BROCHURES FOR PROVENA AND SV. PROVIDED SALES REP CONTACT INFORMATION. THE CUSTOMER REPORTED AN "INCREASE IN DEEP VEIN THROMBOSIS IN PATIENTS" HOWEVER THE EXACT NUMBER OF EVENTS WAS NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED 10/12/2023: THE VEIN WAS APPROPRIATELY CHOSEN, NO CHANGE IN TECHNIQUE, NO EXTERNAL COMPRESSION. EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. IT WAS STATED NO DEFECT WAS NOTED IN THE PROD

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18112134 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT HIS FACILITY PLACES THE 4FR DL POWERPICC PROVENA. CALLER STATES HE IS LOOKING TO PLACE THE 3FR POWERPICC PROVENA OR SV BECAUSE THEY HAVE EXPERIENCED A RECENT INCREASE IN PATIENTS EXPERIENCING DEEP VEIN THROMBOSIS. CALLER DESCRIBES INCREASING USE OF THE BRACHIAL VEIN AS IT IS A LARGER VEIN WHEN PLACING PICCS. CALLER STATES THAT A 3FR MAY HELP WITH THIS ISSUE. CALLER ASKING ABOUT THE POWERPLCC SV WITH SHERLOCK AND POWERPICC KITS ENDING IN THE LETTER "P". MS&S DISCUSSED THE DIFFERENCES IN POWERPICC PROVENA VS SV (INTERNAL DIAMETER, FLOW RATES, ETC). DISCUSSED KIT CONTENTS FOR KITS ENDING IN "P". SUGGESTED HE SPEAK TO HIS SALES REP IN THE AREA TO ASSESS WHICH PRODUCTS WOULD WORK BEST FOR THEIR PATIENT POPULATION. EMAILED BROCHURES FOR PROVENA AND SV. PROVIDED SALES REP CONTACT INFORMATION. THE CUSTOMER REPORTED AN "INCREASE IN DEEP VEIN THROMBOSIS IN PATIENTS" HOWEVER THE EXACT NUMBER OF EVENTS WAS NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED 10/12/2023: THE VEIN WAS APPROPRIATELY CHOSEN, NO CHANGE IN TECHNIQUE, NO EXTERNAL COMPRESSION. EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. IT WAS STATED NO DEFECT WAS NOTED IN THE PROD

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18112132 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT HIS FACILITY PLACES THE 4FR DL POWERPICC PROVENA. CALLER STATES HE IS LOOKING TO PLACE THE 3FR POWERPICC PROVENA OR SV BECAUSE THEY HAVE EXPERIENCED A RECENT INCREASE IN PATIENTS EXPERIENCING DEEP VEIN THROMBOSIS. CALLER DESCRIBES INCREASING USE OF THE BRACHIAL VEIN AS IT IS A LARGER VEIN WHEN PLACING PICCS. CALLER STATES THAT A 3FR MAY HELP WITH THIS ISSUE. CALLER ASKING ABOUT THE POWERPLCC SV WITH SHERLOCK AND POWERPICC KITS ENDING IN THE LETTER "P". MS&S DISCUSSED THE DIFFERENCES IN POWERPICC PROVENA VS SV (INTERNAL DIAMETER, FLOW RATES, ETC). DISCUSSED KIT CONTENTS FOR KITS ENDING IN "P". SUGGESTED HE SPEAK TO HIS SALES REP IN THE AREA TO ASSESS WHICH PRODUCTS WOULD WORK BEST FOR THEIR PATIENT POPULATION. EMAILED BROCHURES FOR PROVENA AND SV. PROVIDED SALES REP CONTACT INFORMATION. THE CUSTOMER REPORTED AN "INCREASE IN DEEP VEIN THROMBOSIS IN PATIENTS" HOWEVER THE EXACT NUMBER OF EVENTS WAS NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 10/12/2023: THE VEIN WAS APPROPRIATELY CHOSEN, NO CHANGE IN TECHNIQUE, NO EXTERNAL COMPRESSION. EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. IT WAS STATED NO DEFECT WAS NOTED IN THE P

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17916918 ↗
• MalfunctionApr 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PROVENA POWER PICC 5 FR TL SECURED WITH A SECURACATH WAS FOUND LEAKING RIGHT WHERE THE SECURACATH'S LEGS ARE. ADD INFO RCVD: WAS THERE PATIENT HARM REPORTED?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757260 ↗
• MalfunctionApr 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TWO 5FR TL PROVENA PICC WITH A SECURACATH WERE LEAKING WHERE THE SECURACATH LEGS WERE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757253 ↗
• MalfunctionApr 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TWO 5FR TL PROVENA PICC WITH A SECURACATH WERE LEAKING WHERE THE SECURACATH LEGS WERE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757246 ↗
• MalfunctionApr 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "PLASTIC FOUND INSIDE SYRINGE BEFORE USE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749786 ↗
• MalfunctionJul 10, 2019Obstruction of Flow

  IT WAS REPORTED THAT THE FACILITY IS EXPERIENCING A HIGH RATE OF OCCLUSIONS WITH THE PROVENA DL CATHETERS. IT WAS STATED THAT THERE WAS 8 REPORTS SUBMITTED FROM FLOOR NURSES WHO HAD COMPLETE OCCLUSIONS, AND THE PICCS WERE UNABLE TO BE CATHFLO¿D SUCCESSFULLY. THIS REPORT ADDRESSES THE EIGHTH PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8778074 ↗
• MalfunctionJul 10, 2019Complete Blockage

  IT WAS REPORTED THAT THE FACILITY IS EXPERIENCING A HIGH RATE OF OCCLUSIONS WITH THE PROVENA DL CATHETERS. IT WAS STATED THAT THERE WAS 8 REPORTS SUBMITTED FROM FLOOR NURSES WHO HAD COMPLETE OCCLUSIONS, AND THE PICCS WERE UNABLE TO BE CATHFLO¿D SUCCESSFULLY. THIS REPORT ADDRESSES THE SEVENTH PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8778067 ↗
• MalfunctionJul 10, 2019Complete Blockage

  IT WAS REPORTED THAT THE FACILITY IS EXPERIENCING A HIGH RATE OF OCCLUSIONS WITH THE PROVENA DL CATHETERS. IT WAS STATED THAT THERE WAS 8 REPORTS SUBMITTED FROM FLOOR NURSES WHO HAD COMPLETE OCCLUSIONS, AND THE PICCS WERE UNABLE TO BE CATHFLO¿D SUCCESSFULLY. THIS REPORT ADDRESSES THE SIXTH PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8778065 ↗
• MalfunctionJul 10, 2019Complete Blockage

  IT WAS REPORTED THAT THE FACILITY IS EXPERIENCING A HIGH RATE OF OCCLUSIONS WITH THE PROVENA DL CATHETERS. IT WAS STATED THAT THERE WAS 8 REPORTS SUBMITTED FROM FLOOR NURSES WHO HAD COMPLETE OCCLUSIONS, AND THE PICCS WERE UNABLE TO BE CATHFLO¿D SUCCESSFULLY. THIS REPORT ADDRESSES THE FIFTH PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8778064 ↗
• MalfunctionJul 10, 2019Complete Blockage

  IT WAS REPORTED THAT THE FACILITY IS EXPERIENCING A HIGH RATE OF OCCLUSIONS WITH THE PROVENA DL CATHETERS. IT WAS STATED THAT THERE WAS 8 REPORTS SUBMITTED FROM FLOOR NURSES WHO HAD COMPLETE OCCLUSIONS, AND THE PICCS WERE UNABLE TO BE CATHFLO¿D SUCCESSFULLY. THIS REPORT ADDRESSES THE THIRD PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777982 ↗
• MalfunctionJul 10, 2019Obstruction of Flow

  IT WAS REPORTED THAT THE FACILITY IS EXPERIENCING A HIGH RATE OF OCCLUSIONS WITH THE PROVENA DL CATHETERS. IT WAS STATED THAT THERE WAS 8 REPORTS SUBMITTED FROM FLOOR NURSES WHO HAD COMPLETE OCCLUSIONS, AND THE PICCS WERE UNABLE TO BE CATHFLO¿D SUCCESSFULLY. THIS REPORT ADDRESSES THE SECOND PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777981 ↗
• MalfunctionJul 10, 2019Complete Blockage

  IT WAS REPORTED THAT THE FACILITY IS EXPERIENCING A HIGH RATE OF OCCLUSIONS WITH THE PROVENA DL CATHETERS. IT WAS STATED THAT THERE WAS 8 REPORTS SUBMITTED FROM FLOOR NURSES WHO HAD COMPLETE OCCLUSIONS, AND THE PICCS WERE UNABLE TO BE CATHFLO¿D SUCCESSFULLY. THIS REPORT ADDRESSES THE FOURTH PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777978 ↗
• MalfunctionJul 10, 2019Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT 3 PROVENA PICCS WERE OCCLUDED IN THE BONE MARROW TRANSPLANT UNIT, IN THE MIDDLE OF STEM CELL INFUSIONS. IT WAS STATED THAT THE PICCS WERE UNABLE TO BE CATHFLO'D SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT ADDRESSES THE THIRD PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777876 ↗
• MalfunctionJul 10, 2019Obstruction of Flow

  IT WAS REPORTED THAT 3 PROVENA PICCS WERE OCCLUDED IN THE BONE MARROW TRANSPLANT UNIT, IN THE MIDDLE OF STEM CELL INFUSIONS. IT WAS STATED THAT THE PICCS WERE UNABLE TO BE CATHFLO'D SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT ADDRESSES THE SECOND PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777866 ↗
• MalfunctionJul 10, 2019Complete Blockage

  IT WAS REPORTED THAT 3 PROVENA PICCS WERE OCCLUDED IN THE BONE MARROW TRANSPLANT UNIT, IN THE MIDDLE OF STEM CELL INFUSIONS. IT WAS STATED THAT THE PICCS WERE UNABLE TO BE CATHFLO'D SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT ADDRESSES THE FIRST PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777855 ↗
• MalfunctionApr 19, 2018Leak/Splash; Nonstandard Device

  PER MEDWATCH; REPORTEDLY, PATIENT'S PRESENTED TO IR WITH A LEAKING PICC LINE PLACED 3 WEEKS AGO. THE PICC LINE WAS REPLACED WITH A 5FR D/LPICC.

  Patient problems: No Code Available

  MAUDE report 7445415 ↗
• MalfunctionApr 13, 2018Fluid/Blood Leak; Nonstandard Device

  PER MEDWATCH IT WAS REPORTED THE PATIENT'S PICC LINE WAS FOUND TO HAVE A LEAK AT THE END OF THE RED HUB. THE PICC WAS REMOVED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7429785 ↗
• MalfunctionApr 6, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT'S RIGHT UPPER EXTREMITY PICC WAS MALFUNCTIONING. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7403708 ↗
• MalfunctionApr 6, 2018Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT UPPER EXTREMITY PICC BROKE AT THE HUB AND THE PATIENT WAS REPORTEDLY REFERRED FOR REPLACEMENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7403704 ↗
• MalfunctionNov 22, 2017Crack; Fluid/Blood Leak

  THE FACILITY REPORTED THAT THE NURSE WENT TO FLUSH THE PICC LINE PER PROTOCOL. UPON FLUSHING THE LUMEN WITH THE RED HUB, IT WAS NOTED THAT THE LINE WAS LEAKING DIRECTLY BELOW THE RED HUB. UPON INSPECTION, THE NURSE FOUND A CRACK BELOW THE RED HUB. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7053885 ↗