Broviac 0601620Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741074479), received between Apr 1, 2016 and Dec 18, 2025 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 4, 2023Open, Classified

   Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

   Z-1051-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER. POST PLACEMENT, IT WAS NOTED THERE WAS A SPLIT ON THE CATHETER JUST ABOVE THE HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836193 ↗
• MalfunctionDec 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6),2024, A PATIENT UNDERWENT A REPAIR KIT PLACEMENT PROCEDURE USING THE HICKMAN/LEONARD/BROVIAC REPAIR KIT. ON(B)(6), 2025, POST-PLACEMENT, IT WAS NOTED THERE WAS A SPLIT ON THE CATHETER JUST ABOVE THE HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836185 ↗
• MalfunctionApr 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST CATHETER REPAIR KIT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727567 ↗
• InjuryFeb 18, 2022Difficult to Flush; Device Dislodged or Dislocated; Migration; Difficult to Flush; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT POST CATHETER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO FLUSH. IT WAS LATER NOTED THAT STENT INSIDE THE BODY HAD MIGRATED. THE LINE WAS SURGICALLY REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13556960 ↗
• MalfunctionAug 20, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE AND DURING PREPARATION, THE CATHETER OF THE DEVICE WAS ALLEGEDLY FOUND TO BE BROKEN. IT WAS FURTHER REPORTED THAT AN ABNORMAL LEAK WAS IDENTIFIED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346809 ↗
• MalfunctionJul 22, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE ALLEGEDLY FRACTURED AT THE BASE OF CATHETER AND LEAKED. THE PROCEDURE WAS COMPLETED USING REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12208194 ↗
• MalfunctionNov 4, 2020Fluid/Blood Leak; Reflux within Device; Fluid/Blood Leak; Reflux within Device

  IT WAS REPORTED THAT POST PROCEDURE, THE DEVICE ALLEGEDLY MALFUNCTIONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10783178 ↗
• MalfunctionApr 9, 2020Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600540 CHRONIC CATHETER ALLEGEDLY EXPERIENCED FRACTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9944390 ↗
• MalfunctionJan 16, 2020Obstruction of Flow; Obstruction of Flow

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0601620. CHRONIC CATHETER REPAIR KIT ALLEGEDLY EXPERIENCE OBSTRUCTION OF FLOW. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9595878 ↗
• MalfunctionJan 15, 2020Break; Fracture; Break; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0601620 PORT AND CATHETER ACCESSORIES ALLEGEDLY EXPERIENCED A BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE BREAK MALFUNCTION, ONE INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THERE WAS NO PROVIDED PATIENT INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591056 ↗
• MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0601620. CHRONIC CATHETER ALLEGEDLY EXPERIENCED FLUID LEAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9205648 ↗
• MalfunctionJul 23, 2019Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0601620 BROVIAC CHRONIC CATHETER REPAIRS ALLEGEDLY EXPERIENCED A MATERIAL DEFORMATION. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. BOTH EVENTS DID INVOLVE PATIENTS WITH NO REPORTED PATIENT INJURY. ONE PATIENT IS 49 YEARS OLD, 67 KGS, AND MALE; HOWEVER, THE SECOND PATIENTS¿ WAS FEMALE AND WEIGHT AND AGE WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817818 ↗
• MalfunctionApr 18, 2019Burst Container or Vessel; Fracture; Burst Container or Vessel; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 0601620 CHRONIC CATHETER REPAIR KIT ALLEGEDLY EXPERIENCED A BURST AND A FRACTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE DEVICE WAS USED INSIDE THE (B)(6) YEAR-OLD MALE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8528421 ↗
• MalfunctionApr 18, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 0601620 CHRONIC CATHETER REPAIR EXPERIENCED A DEVICE DETACHMENT AND A DEVICE DISLODGED OR DISLOCATED. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT WAS REPORTED AS A (B)(6) YEAR OLD MALE WHOSE WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8528412 ↗
• MalfunctionApr 17, 2019Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  THIS REPORT SUMMARIZES ONE(1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 0601620 CHRONIC CATHETER REPAIR KIT ALLEGEDLY FOUND DAMAGED. IT WAS FURTHER REPORTED THAT THE DAMAGED SECTION WAS REMOVED AND THE CATHETER WAS REPAIRED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525532 ↗
• MalfunctionJul 11, 2018Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT A NUTRITION CATHETER ALLEGEDLY CLOGGED. IT WAS FURTHER ALLEGED THAT THE NUTRITION CATHETER WAS REPAIRED APPROXIMATELY NINE MONTHS AGO. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Occlusion

  MAUDE report 7680153 ↗
• MalfunctionMay 22, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FACILITY HAS ALLEGED THE CATHETER HAS HOLES IN THE TUBING, SMALL SPLITS IN THE TUBING AND/OR SEPARATION AT THE REPAIR KIT. DEVICE WAS REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7535522 ↗
• MalfunctionJan 5, 2018Leak/Splash

  IT WAS REPORTED THAT THIS REPAIR KIT WAS USED IN (B)(6) 2017. DURING INFUSION A LEAK WAS OBSERVED FROM BETWEEN THE CATHETER AND THE CONNECTING SLEEVE. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7170077 ↗
• MalfunctionNov 29, 2017Break; Occlusion Within Device; Failure to Deliver

  IT WAS REPORTED THAT THE METAL SHEATH OF THE CATHETER REPAIR BROKE AWAY FROM THE SEPARATION AND OBSTRUCTED THE CENTRAL VENOUS CATHETER. PARENTERAL NUTRITION WAS UNABLE TO BE DELIVERED. A CHEST X-RAY REVEALED THAT THE SHEATH WAS NEAR THE ORIFICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068992 ↗
• MalfunctionJul 19, 2017Hole In Material

  SALES REP REPORTED THAT FACILITY HAS PREVIOUSLY REPORTED ISSUES OF A PINHOLE WHERE THE SILICONE GOES INTO THE PLASTIC. FACILITY REPORTED PREVIOUS EXPLANATION OF CLAMPING IN THE INAPPROPRIATE AREA HOWEVER FACILITY IS REPORTING A "JAGGED EDGE ON SOME OF THE PLASTIC THAT IS UNDER THE SILICONE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6724705 ↗
• MalfunctionJul 19, 2017Break

  IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE DAMAGED AND WAS REPAIRED. NO OTHER INFORMATION WAS PROVIDED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6724394 ↗
• MalfunctionJul 18, 2017Physical Property Issue

  IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE DAMAGED. THE CATHETER WAS REPAIRED. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT ADDRESSES REPAIR ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6722273 ↗
• MalfunctionJul 18, 2017Break

  IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE DAMAGED. THE CATHETER WAS REPAIRED. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT ADDRESSES REPAIR FOUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6722266 ↗
• MalfunctionJul 18, 2017Break

  IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE DAMAGED. THE CATHETER WAS REPAIRED. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT ADDRESSES REPAIR TWO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6722264 ↗
• MalfunctionJul 18, 2017Break

  IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE DAMAGED. THE CATHETER WAS REPAIRED. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT ADDRESSES REPAIR THREE.

  Patient problems: No Information

  MAUDE report 6722262 ↗