Groshong NXT ClearVue Catheter 9655405Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741036026), received between Nov 10, 2015 and Nov 29, 2022 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "HOLE WAS FOUND IN THE CATHETER PRIOR TO INSERTION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880913 ↗
• MalfunctionApr 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED PATIENT WAS RECEIVING OUT PATIENT TREATMENT VIA PICC. COMMUNITY NURSE FLUSHED PICC LINE AND PRODUCT CAME APART. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757285 ↗
• MalfunctionMar 5, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE TLS STYLET WAS TESTED BEFORE USE AND IT BROKE. THE DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9794032 ↗
• MalfunctionNov 29, 2018Infusion or Flow Problem

  IT WAS REPORTED THAT THE CONTRAST FLUID WAS INJECTED AT A RESTRICTED FLOW OF 0.9 ML/SEC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8118458 ↗
• MalfunctionJul 5, 2018Material Integrity Problem

  IT WAS REPORTED THAT DURING INSPECTION OF THE CATHETER WHILE FLUSHING ON (B)(6) 2018, "THERE WAS BULGING NOTED AT THE CLEAR PART OF THE LINE." THE PICC WAS REPAIRED RATHER THAN REMOVED, AND IS STILL IN THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7664737 ↗
• MalfunctionJun 20, 2018Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED THAT WHILE REPORTER WAS FLUSHING THE PATIENTS PICC LINE THE FLUSH ALLEGEDLY STARTED TO COME OUT OF A HOLE IN THE LINE, ABOVE THE INSERTION SITE. PICC ALLEGEDLY LEAKING AT THE END OF THE CLEAR CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7621124 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY HAD A POSSIBLE REACTION TO THE PICC POST FLUSH. THE PATIENT ALLEGEDLY STARTED EXPERIENCING A INCREASED LEVEL OF ANXIETY, UPSET, CRYING COMPLAINT OF MID ABDOMINAL PAIN RADIATING TO THE RIGHT SIDE OF THE BODY AND CHEST. THE PATIENT ALSO COMPLAINED OF SHORTNESS AND DIFFICULTY BREATHING, THE PATIENTS FACE WAS FLUSHED AND RED. THIS ALLEGEDLY OCCURRED WHEN THE PICC WAS FLUSHED POST TRIMMING AND EXTENSION LEG PLACED AND WITH THE PLACEMENT OF THE SECURACATH. THE PICC WAS THEN FLUSHED WITH 20 ML STERILE NORMAL SALINE. THE SHERLOCK NAVIGATION SYSTEM WAS UNABLE TO PICK UP THE TIP OF THE PICC DURING INSERTION. PICC INSERTED ACCORDING TO THE LUMS MEASUREMENT.

  Patient problems: Abdominal Pain; Reaction; Skin Discoloration

  MAUDE report 6803550 ↗
• MalfunctionJul 21, 2017Fracture

  IT WAS REPORTED THAT ON (B)(6) THERE WAS AN ALLEGED FRACTURED PICC TO CLEAR EXTENSION. USUALLY WEAKEST POINT OF THE PICC LINE IS THE CONNECTION BETWEEN THE CATHETER AND THE EXTENSION LEG, IN THIS CASE, ALLEGEDLY, THE CLEAR PORTION FRACTURED WHICH IS CONCERNING. THE PICC WAS REPAIRED WITH SUCCESS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6732746 ↗
• InjuryJun 21, 2016Insufficient Device Problem Information

  NURSE REPORTED A PATIENT REACTION POST PICC INSERTION. THEY STATED THAT THE PATIENT COMPLAINED OF CHEST HEAVINESS, FACIAL FLUSHING, AND ANXIETY. NURSE STATED THAT THE INITIAL SYMPTOMS DECREASED AFTER 10-20 SECONDS AND THAT ALL SYMPTOMS RESOLVED AFTER 15 MINUTES.

  Patient problems: Anxiety; Discomfort; Reaction

  MAUDE report 5740149 ↗
• InjuryMay 10, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST PICC INSERTION, THE PATIENT NOTED TIGHTNESS TO BACK OF THROAT. THE PATIENT'S EARS REDDENED AND THEIR FACE FLUSHED SLIGHTLY, HOWEVER SYMPTOMS RESOLVED WITHIN 5 MINUTES. PICC LEFT IN SITU.

  Patient problems: Skin Discoloration

  MAUDE report 5643143 ↗
• InjuryNov 10, 2015Insufficient Device Problem Information

  IT WAS REPORTED THAT POST PICC INSERTION, ONCE THE GUIDEWIRE WAS REMOVED AND LINE FLUSHED WITH NORMAL SALINE, THE PATIENT REPORTEDLY COMPLAINED OF WARMTH & TIGHTNESS TO HEAD & NECK. THE PATIENT'S FACE WAS SAID TO HAVE BEEN FLUSHED (BEET READ), THERE WAS NO CHEST PAIN OR SHORTNESS OF BREATH. THE HEAD OF THE BED WAS RAISED, VITAL SIGNS TAKEN AND SYMPTOMS REPORTEDLY RESOLVED WITHIN 6 MINUTES.

  Patient problems: Complaint, Ill-Defined; Erythema

  MAUDE report 5215670 ↗