Groshong 7711804Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741036767), received between Jul 11, 2016 and Feb 9, 2026 — classified as 5 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Fracture; Stretched; Unraveled Material; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING GROSHONG SINGLE LUMEN CV CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT ON THE PREVIOUS DAY USING AN 8F SINGLE LUMEN GROSHONG KIT, AFTER INSERTING THE GUIDEWIRE, IT REPEATEDLY COILED UNDER X RAY AND ATTEMPTS TO ADVANCE IT RESULTED IN THE WIRE BECOMING STUCK INSIDE THE INTRODUCER NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290687 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY DEVELOPED WITH THROMBOSIS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23484010 ↗
• MalfunctionAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE GROSHONG S/L CATHETERS. POST THE PROCEDURE, A CATHETER WAS REMOVED FOR A PATIENT WITH AGE AND COMORBIDITIES. AFTER THE REMOVAL PROCEDURE, ON THE FOLLOWING DAY, THE PATIENT RETURNED COMPLAINING OF CHEST PAIN RADIATING DOWN HIS LEFT SHOULDER/ARM. THE PATIENT WAS DISCHARGED. LATER, THE SURGEON IDENTIFIED WHILE CHECKING MR, THAT THE RETAINED FRAGMENT THAT CONSISTS OF THE DISTAL GROSHONG CATHETER TIP CONTAINING THE EMBEDDED REINFORCING WIRE WAS STILL PRESENT IN THE PATIENT.

  Patient problems: Pain

  MAUDE report 22783363 ↗
• InjuryAug 12, 2025Fracture; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Material Protrusion/Extrusion; Migration; Fracture; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Material Protrusion/Extrusion; Migration

  A PATIENT UNDERWENT A PORT PLACEMENT PROCEDURE USING THE GROSHONG S/L CATHETERS. POST THE PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE CATHETER WAS REMOVED DUE TO AGE AND COMORBIDITIES OF PATIENT. A PROMINENCE WAS NOTED OVER THE RIGHT NECK. CHEST XRAY REVEALED A LINEAR OPAQUE STRUCTURE CONSISTENT WITH RETAINED INTERNAL REINFORCING WIRE FROM THE GROSHONG. THE PATIENT RETURNED TO THE OR FOR REMOVAL. AND IT WAS IDENTIFIED THAT RETAINED FRAGMENT AS CONSISTENT WITH THE DISTAL GROSHONG CATHETER TIP CONTAINING THE EMBEDDED REINFORCING WIRE. AND REFLECTS MECHANICAL SEPARATION AT THE TIP-TO-BODY JUNCTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 22782135 ↗
• MalfunctionJun 23, 2025Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component; Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A CHRONIC CATHETER PLACEMENT PROCEDURE USING GROSHONG S/L CATHETER. DURING THE PREPARATION OF A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CUFF OF THE GROSHONG CATHETER HAD ALLEGEDLY COME OFF WHILE TUNNELING. THIS ALL OCCURRED OUTSIDE OF THE PATIENT. CATHETER MALFUNCTIONED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307057 ↗
• MalfunctionNov 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIMES POST A CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD A CRACK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194102 ↗
• MalfunctionJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED ALLERGIC REACTION. REPORTEDLY, THERE IS NO INFORMATION REGARDING THE TREATMENT OF THE ALLERGIC REACTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285074 ↗
• MalfunctionOct 25, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO CATHETER PLACEMENT PROCEDURE, DEVICE TRAY WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15665495 ↗
• InjuryMay 5, 2022Fracture; Material Separation; Improper or Incorrect Procedure or Method; Migration; Fracture; Material Separation; Improper or Incorrect Procedure or Method; Migration

  IT WAS REPORTED THAT APPROXIMATELY SEVEN YEARS AND FOUR MONTHS POST CHRONIC CATHETER PLACEMENT IN THE RIGHT SIDE OF CHEST, THE CATHETER ALLEGEDLY BROKE OFF AND MIGRATED THROUGH HEART AND TO LUNG. IT WAS FURTHER REPORTED THAT HEART CATHETERIZATION WAS PERFORMED TO REMOVE THE BROKEN CATHETER PART FROM THE PATIENT'S LUNG. THE PATIENT EXPERIENCED SEVERE CHEST PAIN. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 14286816 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOME TIME POST PORT DEVICE IMPLANT, THE PATIENT ALLEGEDLY EXPERIENCED AN INFECTION AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema; Unspecified Infection

  MAUDE report 12099856 ↗
• MalfunctionApr 15, 2020Loss of or Failure to Bond; Fluid/Blood Leak; Fracture; Loss of or Failure to Bond; Fluid/Blood Leak; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 7711804 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A LOSS OR FAILURE TO BOND. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THERE WAS NO PATIENT INVOLVED, THEREFORE NO PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9965564 ↗
• MalfunctionJan 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7711804 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT. THE AGE, WEIGHT, AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9602372 ↗
• MalfunctionJan 17, 2020Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATED THAT MODEL 7711804, CENTRAL VENOUS CATHETER, ALLEGED EXPERIENCED FRACTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9602174 ↗
• MalfunctionJul 18, 2019Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7711804 CHRONIC CATHETER ALLEGEDLY EXPERIENCED FLUID LEAK AND FRACTURE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803033 ↗
• MalfunctionApr 19, 2019Defective Component; Defective Component

  THIS REPORT SUMMARIZES ONE(1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 7711804 CHRONIC CATHETER DURING CATHETER INSERTION, THE CUFF ALLEGEDLY CAME OFF. IT WAS FURTHER REPORTED THAT THE DEVICE REPLACED WITH ANOTHER ONE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE FEMALE PATIENT, (B)(6) YEARS OF AGE WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532598 ↗
• InjuryNov 28, 2018Defective Component; Defective Component

  IT WAS REPORTED THE CUFF ALLEGEDLY DETACHED COMPLETELY OFF THE CHRONIC CATHETER DURING INSERTION. IT WAS FURTHER REPORTED THAT THE DETACHED CUFF HAD TO BE RETRIEVED. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 8113201 ↗
• MalfunctionNov 27, 2018Defective Component; Defective Component

  IT WAS REPORTED THE CUFF ALLEGEDLY DETACHED BUT REMAINED ON THE CHRONIC CATHETER DURING INSERTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8108254 ↗
• MalfunctionJul 25, 2018Suction Problem; Suction Problem

  IT WAS REPORTED THAT THE CATHETER COULD BE FLUSHED EASILY, BUT COULD NOT BE ASPIRATED. THE CATHETER WAS REPOSITIONED AND THE GUIDEWIRE WAS ADVANCED OUT, BUT THE CATHETER COULD STILL NOT BE ASPIRATED. CONTRAST WAS INJECTED USING A CENTRAL VENOGRAM TO ENSURE PROPER INTRALUMINAL POSITION WITHIN THE SVC/RIGHT ATRIUM, WHICH WAS NORMAL. A NEW DEVICE WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7718577 ↗
• MalfunctionJan 3, 2018Leak/Splash; Split

  IT WAS REPORTED BY THE FACILITY THAT THE GROSHONG WORKED OKAY AND THEN TODAY A LEAK WAS NOTED AT THE INSERTION SITE. THE CATHETER WAS REMOVED ON (B)(6) 2017 AND A SPLIT WAS NOTED NEAR THE END OF THE CATHETER. NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7162730 ↗
• MalfunctionDec 28, 2017Material Integrity Problem

  DURING EVALUATION BY THE ENGINEER IT WAS DISCOVERED THAT THE CUFF HAD COME OFF THE CATHETER. NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7153399 ↗
• MalfunctionNov 17, 2017Bent

  IT WAS REPORTED BY THE PHYSICIAN THAT THEY HAD DIFFICULTY PLACING THE DEVICE. IT WAS NOTED THAT THE TIP OF THE CATHETER WAS BENT AND A "CLOGGED" PIECE CAME OFF DURING PLACEMENT. THE CATHETER WAS NOT USED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7043068 ↗
• MalfunctionApr 7, 2017Device Contamination with Chemical or Other Material

  PER SALES REPRESENTATIVE, THE FACILITY REPORTED THAT IN PREPPING THE PEELAWAY SHEATH, THE TECH NOTICED A CLEAR PLASTIC SHEATH OVER THE VERY TIP OF THE SHEATH THAT THE FACILITY HAD NEVER SEEN THERE BEFORE. IT WAS STATED IT IS ABOUT 3/8¿ LONG AND "NEARLY INVISIBLE". THE TECH SAID HE NOTICED IT AS HE PREPARED TO THREAD THE SHEATH ON TO THE WIRE. IT WAS NOT USED ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6472224 ↗
• MalfunctionApr 5, 2017Failure To Adhere Or Bond

  PER SALES REPRESENTATIVE, THE FACILITY REPORTED THAT DURING PREPPING OF THE CATHETER, THE TECH NOTICED THAT THE TISSUE INGROWTH CUFF WAS NOT ADHERED TO THE CATHETER AND COULD MOVE FREELY UP AND DOWN. THE CATHETER WAS ISOLATED AND A SECOND KIT WAS OPENED AND USED ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6461552 ↗
• MalfunctionMar 16, 2017Detachment Of Device Component

  FACILITY REPORTED TO THE SALES REP THAT DURING THE PROCEDURE THE NURSE WAS PULLING THE TUNNELER AND NOTED THAT THE CUFF WAS NOT ATTACHED TO THE CATHETER. THE PROCEDURE WAS STOPPED, CATHETER WAS REMOVED AND A DUAL LUMEN GROSHONG CATHETER WAS PLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6409745 ↗
• MalfunctionJan 27, 2017Device Slipped

  IT WAS REPORTED BY FACILITY THAT WHEN INSERTING A GROSHONG CV CATHETER, THE WHITE CUFF ON THE CATHETER WAS SAID TO NOT BE PERMANENTLY ATTACHED AND SLID UP AND DOWN THE CATHETER. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6284616 ↗