LeonardRecalls & reported problems across all models

We found 4 models of Leonard by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Feb 3, 2016 and Aug 10, 2023 — classified as 3 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (18 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Leonard recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

Most reported Leonard problems

Leonard models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Leonard 0601750

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  1 recall0 reports
• Leonard 0600630

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  37 reports
• Leonard 0600634

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  8 reports
• Leonard 0600340

  Catheter,intravascular,therapeutic,long-term greater than 30 days
  3 reports

Recent Leonard adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2023Difficult to Flush; Fracture; Difficult to Flush; Fracture

  IT WAS REPORTED THAT ONE MONTH AND FOUR DAYS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY NOT FUNCTIONING APPROPRIATELY. IT WAS FURTHER REPORTED THAT THE PORT MOST LIKELY WOULD NOT FLUSH. REPORTEDLY, LUMEN WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497924 ↗
• MalfunctionJul 24, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FIVE MONTHS AND ONE DAY POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A HOLE IN THE LUMEN. IT WAS FURTHER REPORTED THAT THE PATIENT NO LONGER NEEDED TREATMENTS AND UNDERWENT SURGERY TO REMOVE THE DEVICE COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377374 ↗
• MalfunctionJul 24, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT TWO WEEKS AND FIVE DAYS POST A CHRONIC CATHETER PLACEMENT, THE WHITE LUMEN ALLEGEDLY HAD A SPLIT DURING USE. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376954 ↗
• MalfunctionJul 24, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT ONE MONTH AND THIRTEEN DAYS POST A CHRONIC CATHETER PLACEMENT, THE WHITE LUMEN ALLEGEDLY BROKE. REPORTEDLY, THE LUMEN WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376930 ↗
• MalfunctionJul 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE MONTH AND ONE DAY POST A CHRONIC CATHETER PLACEMENT, THE RED LUMEN HOLE ALLEGEDLY LEAKED. REPORTEDLY, THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376895 ↗
• MalfunctionJul 21, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE LINE WAS ALLEGEDLY FOUND TO BE BROKEN DURING A BLOOD WORK. IT WAS FURTHER REPORTED THAT THE LINE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370262 ↗
• MalfunctionJul 21, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ONE MONTH AND SEVEN DAYS POST CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD HOLE ABOVE THE HUB. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368746 ↗
• MalfunctionJul 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY ONE HUNDRED AND FIFTY EIGHT DAYS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A CRACK IN THE WHITE PATHWAY. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315338 ↗
• MalfunctionJun 28, 2023Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, A SMALL HOLE WAS ALLEGEDLY NOTED WHEN FLUSHING. REPORTEDLY, THE LINE WAS CLAMPED AND OCCLUSIVELY COVERED, AND THE PROCEDURE WAS COMPLETED BY AN EXTERNAL LENGTH REPLACEMENT KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17214721 ↗
• MalfunctionFeb 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13437584 ↗
• MalfunctionSep 2, 2021Fracture; Fracture

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY TEN DAYS POST CATHETER PLACEMENT, THE PATIENT DEVELOPED ADVERSE EVENT OF TORN CATHETER LUMEN DURING REGULAR FLUSHING. THE CATHETER WAS REMOVED AND EXCHANGED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414868 ↗
• MalfunctionAug 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257557 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY TWO WEEK AND ONE DAY POST CATHETER PLACEMENT, THE PATIENT EXPERIENCED MINIMAL PAPULAR DERMATITIS WITH POST-INFLAMMATORY HYPERPIGMENTATION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Rash

  MAUDE report 11452402 ↗
• MalfunctionJan 14, 2020Failure to Infuse; Material Deformation; Failure to Infuse; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600630 CHRONIC CATHETER ALLEGEDLY EXPERIENCED FAILURE TO INFUSE AND MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586738 ↗
• InjuryAug 7, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT APPROXIMATELY SEVEN WEEKS AFTER THE PLACEMENT OF THE CHRONIC CATHETER VIA THE LEFT SUBCLAVIAN VEIN, THE HEALTH CARE PROVIDER DECIDED TO REMOVE THE CHRONIC CATHETER DUE TO THE COMPLETION OF THE TREATMENT. IT WAS FURTHER REPORTED THAT DURING THE DEVICE REMOVAL PROCEDURE, THE HEALTH CARE PROVIDER ALLEGEDLY FINDS RESISTANCE WHILE PULLING THE CATHETER, HOWEVER, WHEN THE CATHETER WAS FINALLY RELEASED THE CUFF WAS DETACHED FROM THE CATHETER AND RETAINED IN THE PATIENT. REPORTEDLY, THE PATIENT EXPERIENCED DISCOMFORT FROM PULLING THE CATHETER, HOWEVER, THE PATIENT REPORTED TO BE IN THE STABLE CONDITION AFTER THE DEVICE REMOVAL PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 8870798 ↗

Other Bard Access Systems, Inc. products

• Port Access Needle122 models · 3,744 reports · 3 recalls
• Groshong NXT ClearVue Catheter8 models · 3,266 reports
• PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
• Site~Rite 8 Ultrasound System11 models · 1,965 reports
• PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
• PowerPICC Provena116 models · 1,337 reports · 2 recalls
• PowerPort M.R.I., Groshong10 models · 1,285 reports
• Navarre15 models · 1,228 reports