Groshong NXT ClearVue Catheter 7655405Recalls & reported problems
Bard Access Systems, Inc. · Groshong NXT ClearVue Catheter 4F Single-Lumen Basic Kit (with Microintroducer) · Class 2 · Implant
All models of Groshong NXT ClearVue Catheter (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Groshong NXT ClearVue catheter is a long-term intravenous catheter placed in a vein. The 1,508 reports most often describe fluid or blood leaking, the catheter material deforming or breaking, and parts not fitting with other components. Some reports mention a foreign body in the patient, and others describe the sheath splitting while the catheter was being opened. The reports list 2 deaths and 177 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,536
- Deaths reported
- 2
- Injuries reported
- 180
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,536 adverse event reports that list this exact device (DI 00801741035272), received between Oct 26, 2015 and Sep 30, 2026 — classified as 2 deaths, 180 injuries, 1,353 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (518 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak518
- Material Deformation265
- Component Incompatible205
- Break152
- Defective Component60
- Adverse Event Without Identified Device or Use Problem50
- Detachment of Device or Device Component42
- Failure to Infuse40
Patient problems
- No Clinical Signs, Symptoms or Conditions1,075
- No Known Impact Or Consequence To Patient115
- Foreign Body In Patient98
- No Consequences Or Impact To Patient94
- Swelling/ Edema36
- Pain32
- Erythema22
- Thrombosis/Thrombus22
Recent adverse event reports
The 25 most recent of 1,536 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Deformation
It was reported that the vascular sheath split. A new catheter was provided to the patient. No other information available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941796 ↗InjurySep 23, 2026Difficult to Insert
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50874621 ↗MalfunctionSep 23, 2026Material Deformation
It was reported that catheter sheath cracked; discovered during pre-use inspection. No further details provided.It was reported this occurred with 2 devices. This report addresses both devices.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870555 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported on September 1, 2026, while a nurse was inserting a central venous catheter via a peripheral access site, she inspected the catheter and discovered a fluid leak; she replaced the catheter and continued with the insertion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870536 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported the head nurse of the Oncology Department encountered fluid leakage from the tubing during the insertion. The patient¿s family noticed the issue, and the head nurse promptly removed the tubing. The tubing has been discarded. No further information was provided. It was reported this occurred with two devices. This report addresses both devices.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863381 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860947 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860026 ↗MalfunctionSep 21, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846050 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
It was reported that a PICC catheter was inserted on (b)(6) 2026. On (b)(6) 2026, following a blood draw, the nurse attempted to administer heparin but encountered resistance. The healthcare professional then aspirated the catheter once. During a subsequent attempt to inject 2 milliliters of solution, the catheter reportedly ruptured. No patient injury were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843270 ↗MalfunctionSep 16, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791397 ↗InjurySep 15, 2026Break
Patient problems: Foreign Body In Patient
MAUDE report 50778974 ↗MalfunctionSep 15, 2026Product Quality Problem
It was reported on (b)(6) 2026, at 11:00 a.m., a PICC catheter was inserted into the patient in accordance with standard operating procedures. After the introducer needle was inserted, good backflow was observed. A guidewire was then advanced; however, resistance was felt at the Needle Tip, confirming that the Needle Tip was within the blood vessel and preventing further advancement of the guidewire. The introducer needle was withdrawn, and upon inspection of the guidewire and introducer needle, resistance was noted when the guidewire was advanced to the Needle Tip, and a barbed tip was discovered on the guidewire. After replacing the catheter with a new one, a new vascular site was selected for puncture. This resulted in the following actual harm and adverse effects to the patient: 1. Secondary mechanical injury to blood vessels and soft tissues: The first puncture had already caused damage to the blood vessels and subcutaneous tissue; due to the catheter placement failure caused by the device malfunction, a site change and repeat puncture were required, leading to secondary injury to the vascular endothelium and subcutaneous tissue, localized puncture pain, and bleeding at the pu
Patient problems: Hematoma; Perforation of Vessels
MAUDE report 50776468 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
It was reported that during placement of an IV infusion after the patient was admitted, a fluid leak occurred; upon inspection, damage was found in the extension tube. There was no reported patient injury. Date of Admission: July 30. Medication administered: High-calorie IV solution.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773784 ↗MalfunctionSep 14, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765662 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
Patient problems: Pain; Swelling/ Edema
MAUDE report 50765660 ↗MalfunctionSep 14, 2026Material Deformation
It was reported that on (b)(6) 2026, at 3:40 p.m., the procedure was performed in accordance with standard operating procedures. During catheter placement, the catheter sheath was inserted approximately 1 centimeter into the skin (1 centimeter of the brown section of the catheter sheath) when difficulty in advancing the catheter was encountered. Upon withdrawing the catheter sheath, it was discovered that the tip of the brown section was fractured and slightly curled. The product was immediately replaced, and a second catheterization was performed on the patient. The ruptured and curled section of the catheter sheath penetrated approximately 1 cm into the subcutaneous tissue, causing mechanical damage to the patient¿s subcutaneous tissue and vascular endothelium, resulting in localized pain. The entire PICC kit becomes unusable. No additional information provided.
Patient problems: Pain; Skin Tears
MAUDE report 50757470 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735873 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: Swelling/ Edema
MAUDE report 50717373 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported at the end of the patient¿s treatment cycle, the PICC catheter needed to be removed. A routine color Doppler ultrasound examination of the upper extremity veins was performed, and the results indicated thrombosis in the middle segment of the subclavian vein in the left upper arm (length: 1.5 cm; widest point: 0.21 cm). The physician prescribed 15 mg of oral rivaroxaban for symptomatic treatment. After a follow up ultrasound showed normal results, the PICC catheter was removed. (The patient has been discharged and is recuperating at home.)
Patient problems: Thrombosis/Thrombus
MAUDE report 50713988 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient¿s PICC catheter has reached the end of its one year usage period, and removal is planned. An ultrasound examination of the upper extremity vessels revealed an isoechoic area measuring approximately 1.0 cm in length and 0.13 cm at its thickest point, located around the catheter within the lumen of the proximal end of the right brachial vein. The physician ordered 15 mg of rivaroxaban tablets for oral administration. A follow up ultrasound revealed that the mural thrombus persisted, and oral medication was continued. No further information was provided .
Patient problems: Thrombosis/Thrombus
MAUDE report 50713987 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Swelling/ Edema; Thrombosis/Thrombus
MAUDE report 50702124 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702122 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erythema; Thrombosis/Thrombus
MAUDE report 50700893 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
It was reported PICC line inserted on (b)(6) and after a month in was observed during weekly dressing and flushing, there were Internal leakage of Groshong PICC line and they had to remove and inserted fresh PICC and continued treatment. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693902 ↗MalfunctionSep 2, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573348 ↗
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- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC Catheter 3275118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days272 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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