Groshong® Catheter 7717405Recalls & reported problems

Summary

The FDA's MAUDE database contains 279 adverse event reports that list this exact device (DI 00801741035326), received between Dec 4, 2015 and Sep 15, 2026 — classified as 103 injuries, 176 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (104 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 279 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50780219 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50702907 ↗
• MalfunctionAug 25, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50431558 ↗
• MalfunctionMay 5, 2026Break; Product Quality Problem

  IT WAS REPORTED, THE PATIENT WAS ADMITTED TO THE DEPARTMENT OF HEMATOLOGY ON (B)(6) 2025, FOR DIFFUSE LARGE B-CELL LYMPHOMA, WHERE A PICC LINE WAS PLACED FOR CHEMOTHERAPY. ON (B)(6) 2026, THE PATIENT WAS ADMITTED TO THE DEPARTMENT OF GASTROENTEROLOGY DUE TO COMMON BILE DUCT STONES. BECAUSE THE PATIENT WAS ON A FASTING REGIMEN DUE TO THE STONES AND REQUIRED PARENTERAL NUTRITION, THE PICC LINE WAS USED FOR INTRAVENOUS INFUSION. AT 6:10 PM ON (B)(6) A NURSE ON ROUNDS NOTICED THAT FLUID WAS NOT DRIPPING FROM THE PICC LINE. UPON INSPECTION, THE NURSE OBSERVED OBVIOUS SIGNS OF THE ADHESIVE TAPE HAVING BEEN TORN, WITH PARTS OF IT DETACHED FROM THE SKIN. UPON INQUIRY, IT WAS LEARNED THAT THE PATIENT HAD FELT THE ADHESIVE TAPE WAS TOO TIGHT AND UNCOMFORTABLE, SO THEY REMOVED IT THEMSELVES WITHOUT NOTIFYING THE MEDICAL STAFF. THIS CAUSED THE BLUE EXTENSION TUBE OF THE PICC TO BREAK AT THE CONNECTION POINT DUE TO STRESS. EXAMINATION REVEALED THE MAIN CATHETER WAS INTACT, WITH NO RESIDUAL SEGMENTS LEFT IN THE BODY. INFUSION WAS IMMEDIATELY STOPPED, AND THE PROXIMAL END OF THE PICC CATHETER WAS CLAMPED. THE PATIENT¿S VITAL SIGNS WERE ASSESSED AS STABLE, WITH NO LOCAL BLEEDING, SWELLING, PAIN, O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082445 ↗
• MalfunctionApr 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THE PICC OUTPATIENT CLINIC AT THE HOSPITAL DISCOVERED FLUID LEAKAGE FROM A PICC LINE DURING A MAINTENANCE PROCEDURE AND REMOVED THE DEVICE FROM THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED: LEAK OCCURRED APPROXIMATELY 10CM AWAY FROM THE INSERTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046364 ↗
• MalfunctionApr 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS FLUID LEAKAGE AT THE 45 CM PRINT SCALE ON THE CATHETER. CATHETER REMOVAL AND REPLACEMENT WITH A NEW CATHETER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966985 ↗
• MalfunctionApr 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2025, AT 11:00 A.M., A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) WAS PLACED FOR CHEMOTHERAPY. ON (B)(6) 2026, DURING A SCHEDULED INPATIENT CHEMOTHERAPY SESSION, CONTINUOUS LEAKAGE WAS OBSERVED AT THE PUNCTURE SITE WHILE PERFORMING MAINTENANCE FLUSHING OF THE PATIENT¿S PICC LINE. UPON PARTIAL REMOVAL OF THE PICC CATHETER, A PERFORATION WAS DISCOVERED 3 CM FROM THE PUNCTURE SITE ALONG THE CATHETER SHAFT. THE CATHETER WAS TRIMMED, AND ALL PARAMETERS RETURNED TO NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823539 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT PLACEMENT OF A PERIPHERALLY INSERTED CENTRAL LINE (PICC) CATHETER KIT AND ASSOCIATED CATHETERS. ON (B)(6) THE PATIENT REPORTED PAIN IN THE ARM ON THE SIDE OF THE CATHETER. A COMPREHENSIVE COLOUR DOPPLER ULTRASOUND OF THE DEEP VEINS OF THE LEFT UPPER LIMB REVEALED ¿POST-PICC THROMBOSIS AND INFLAMMATORY CHANGES IN THE LEFT AXILLARY AND BRACHIAL VEINS¿. IN ACCORDANCE WITH MEDICAL ADVICE, THE PATIENT WAS TREATED WITH SUBCUTANEOUS INJECTIONS OF LOW-MOLECULAR-WEIGHT HEPARIN CALCIUM COMBINED WITH ORAL RIVAROXABAN FOR ANTICOAGULATION, AND THE SWELLING IN THE PATIENT¿S ARM GRADUALLY SUBSIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24779454 ↗
• MalfunctionMar 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE PREPARING TO ADMINISTER AN IV INFUSION TO A PATIENT, THE NURSE OBSERVED SWELLING ON THE ARM WHERE THE CATHETER WAS INSERTED, PARTICULARLY AT THE PICC INSERTION SITE. WITH PARTICULARLY NOTICEABLE SWELLING IN THE SURROUNDING AREA. DURING INFUSION, THE PATIENT REPORTED PAIN AND DRAINAGE AT THE PUNCTURE SITE. THE NURSE SUSPECTED CATHETER DAMAGE. UPON WITHDRAWING THE CATHETER 5 CM AND FLUSHING, LEAKAGE WAS DETECTED AT THE 12 CM MARK. THIS PICC HAD BEEN IN PLACE FOR ONLY TWO MONTHS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24591852 ↗
• InjuryFeb 27, 2026Break

  IT WAS REPORTED THAT A PICC LINE WAS INSERTED AS MEDICALLY PRESCRIBED FOR LONG-TERM INTRAVENOUS CHEMOTHERAPY. ON (B)(6) 2026, AFTER COMPLETING CHEMOTHERAPY, THE PICC CATHETER WAS REMOVED. DURING THE PROCEDURE, THE CATHETER FRACTURED, LEAVING A 23.5 CM SEGMENT RETAINED WITHIN THE PATIENT. THE PROCEDURE WAS IMMEDIATELY HALTED. THE PATIENT WAS INSTRUCTED TO REMAIN BEDRIDDEN WITH IMMOBILIZATION, AND HER EMOTIONS WERE CALMED. FOLLOWING MEDICAL ORDERS, CTA AND PULMONARY ARTERY CTA EXAMINATIONS WERE PERFORMED. THE PATIENT WAS ESCORTED FOR IMAGING. AFTER COMPLETION, SHE WAS TRANSFERRED TO THE INTERVENTIONAL VASCULAR SURGERY DEPARTMENT FOR PICC STUMP EXTRACTION SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24472579 ↗
• InjuryFeb 27, 2026Break

  IT WAS REPORTED THAT DURING THE REMOVAL OF A PICC LINE FOR A PATIENT, THE CATHETER SUDDENLY FRACTURED. A 23.5 CM SEGMENT REMAINED LODGED WITHIN THE PATIENT'S BODY. IMMEDIATELY CONSULTED THE INTERVENTIONAL RADIOLOGY DEPARTMENT AND PERFORMED AN INTERVENTIONAL PROCEDURE TO EXTRACT THE RETAINED CATHETER. THE PICC CATHETER HAD BEEN IN PLACE FOR ONLY ABOUT FIVE MONTHS, NOT THE FULL YEAR SPECIFIED IN THE INSTRUCTIONS. NO DIFFICULTY WAS ENCOUNTERED DURING REMOVAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24471308 ↗
• MalfunctionFeb 24, 2026Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, AT 17:20 UNDER ULTRASOUND GUIDANCE, NURSING STAFF PERFORMED A PICC LINE PLACEMENT PROCEDURE. AFTER SUCCESSFUL PUNCTURE, A GUIDEWIRE WAS ADVANCED. FOLLOWING INSERTION OF THE CATHETER SHEATH, THE GUIDEWIRE WAS WITHDRAWN. DURING BLUNT DISSECTION, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SOFT VENOUS CATHETER, PREVENTING ITS ENTRY INTO THE VESSEL. UPON WITHDRAWAL, THE SOFT CATHETER WAS FOUND TO HAVE FORMED A SNAG. A NEW CENTRAL VENOUS CATHETER WAS IMMEDIATELY SUBSTITUTED, AND PLACEMENT WAS SUCCESSFUL. THIS RESULTED IN SIGNIFICANT BLEEDING AT THE PUNCTURE SITE, WHICH WAS MANAGED BY APPLYING IMMEDIATE PRESSURE TO ACHIEVE HEMOSTASIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24430369 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DUE TO POOR VASCULAR ELASTICITY, A PICC LINE WAS PLACED IN THE PATIENT'S RIGHT UPPER LIMB PER PHYSICIAN'S ORDERS. X-RAY FINDINGS SHOWED: SUPERIOR VENA CAVA. DURING INFUSION, THE PATIENT EXPERIENCED RECURRENT SWELLING IN THE RIGHT UPPER LIMB. ULTRASOUND EXAMINATION RULED OUT INTRAVASCULAR THROMBOSIS. AFTER EXCLUDING OTHER FACTORS, IT WAS OBSERVED THAT RIGHT UPPER LIMB SWELLING ONLY OCCURRED FOLLOWING INFUSION. FOLLOWING CONSULTATION WITH THE FAMILY, THE PICC LINE WAS REMOVED. POST-REMOVAL EXAMINATION REVEALED DAMAGE AT THE DISTAL END OF THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Swelling/ Edema

  MAUDE report 24381794 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT REQUIRED A PICC LINE FOR CHEMOTHERAPY INFUSION. HOWEVER, A COLOR DOPPLER ULTRASOUND PERFORMED THREE DAYS AFTER CATHETER PLACEMENT REVEALED THROMBOSIS IN THE PICC LINE, NECESSITATING INTERVENTION. PATIENT WERE TREATED WITH ORAL RIVAROXABAN ANTICOAGULATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24199306 ↗
• MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE ONCOLOGY DEPARTMENT FOR TREATMENT OF ESOPHAGEAL SQUAMOUS CELL CARCINOMA. A PICC LINE WAS INSERTED ON (B)(6) 2025, WITH AN INSERTION DEPTH OF 40 CM AND 7 CM OF EXTERNAL EXPOSURE. ON (B)(6) 2025, AFTER COMPLETING AN INFUSION (5FU), THE NURSE RESPONSIBLE FOR THE LINE ENCOUNTERED BLOCKAGE DURING CLOSURE. SODIUM HEPARIN WAS IMMEDIATELY FLUSHED THROUGH THE LINE. DURING FLUSHING, LEAKAGE WAS OBSERVED AT THE DISTAL END OF THE PICC LINE. APPROPRIATE MEASURES WERE PROMPTLY IMPLEMENTED: THE LINE WAS TRIMMED, FOLLOWED BY REPEATED FLUSHING AND CLOSURE PROCEDURES, AFTER WHICH PATENCY WAS RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853443 ↗
• MalfunctionDec 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO OUR HOSPITAL FOR TREATMENT OF BREAST CANCER. FOLLOWING RADICAL MASTECTOMY, A PICC LINE WAS SUCCESSFULLY PLACED. THE CATHETER WAS MAINTAINED ACCORDING TO STANDARD PROTOCOLS DURING THE PLACEMENT PERIOD AND COULD REMAIN IN PLACE FOR UP TO ONE YEAR WITH PROPER CARE. ON (B)(6), THE PATIENT VISITED OUR OUTPATIENT CLINIC FOR EXAMINATION. DURING MEDICATION INFUSION, LEAKAGE WAS DETECTED FROM THE EXTERNAL SEGMENT OF THE PICC LINE, PREVENTING EFFECTIVE DRUG ADMINISTRATION. FOLLOWING ASSESSMENT, THE PHYSICIAN REMOVED THE CATHETER AND SCHEDULED A REINSERTION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803973 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN IV INFUSION AT 23:00 ON (B)(6) 2025, THE NURSE OBSERVED EXUDATE AT THE EXTERNAL DRESSING SITE OF THE PATIENT'S PICC LINE. THE DRESSING WAS IMMEDIATELY CHANGED. WHILE FLUSHING THE CATHETER WITH SALINE SOLUTION, FLUID WAS OBSERVED SPRAYING FROM THE CATHETER TIP, RENDERING IT UNUSABLE. THE SITE WAS RE-DISINFECTED AND COVERED WITH A 3M DRESSING FILM. AN INDWELLING NEEDLE WAS REPLACED TO CONTINUE THE INFUSION. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759565 ↗
• MalfunctionNov 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AFTER CATHETER PLACEMENT, THE CLIENT DISCOVERED LEAKAGE AT THE CATHETER CONNECTION SITE. THIS ISSUE RENDERED THE CATHETER UNUSABLE, NECESSITATING REINSERTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659049 ↗
• InjuryNov 25, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 AT 14:00, DURING ROUTINE PICC LINE INSERTION, THE CATHETER FRACTURED AND REMAINED INSIDE THE PATIENT. THE PATIENT REPORTED NO DISCOMFORT. UNDER INTERVENTIONAL GUIDANCE, THE CATHETER WAS COMPLETELY RETRIEVED VIA CAPTURE TECHNIQUE, AND THE PATIENT EXPERIENCED NO DISCOMFORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23647174 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CATHETER PLACEMENT THE CLIENT DISCOVERED THAT THE GUIDEWIRE HAD PUNCTURED THE CATHETER AND PROTRUDED, RENDERING THE CATHETER UNUSABLE. A NEW CATHETER WAS SUBSEQUENTLY PLACED VIA THE PATIENT'S CONTRALATERAL VESSEL. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583949 ↗
• MalfunctionNov 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE PERFORMING MAINTENANCE ON A PERIPHERAL VENOUS CATHETER FOR A CHEMOTHERAPY PATIENT, THE NURSE DISCOVERED A MINUTE TEAR IN THE EXTERNAL PORTION OF THE CATHETER, POSING A RISK OF FLUID LEAKAGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555793 ↗
• InjuryNov 13, 2025Break; Break

  ON (B)(6) 2025, DURING PICC LINE MAINTENANCE FOR A PATIENT AT THE ONCOLOGY DEPARTMENT, A BROKEN CATHETER WAS DISCOVERED. THE CATHETER HAD BEEN IN PLACE FOR ONE WEEK. THE TECHNICIAN IMMEDIATELY APPLIED A TOURNIQUET TO THE UPPER ARM AND NOTIFIED THE INTERVENTIONAL RADIOLOGIST. THE PHYSICIAN PERFORMED AN INTERVENTIONAL RETRIEVAL PROCEDURE TO EXTRACT THE FRACTURED SEGMENT. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23544986 ↗
• InjuryNov 11, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, A CLIENT FROM THE UROLOGY DEPARTMENT INSERTED A PICC LINE INTO A PATIENT. UPON VISUALIZING GREEN WAVES ON THE ULTRASOUND SCREEN AT THE TARGET POSITION, THE CLIENT RETRIEVED THE INNER GUIDEWIRE FROM THE CATHETER. WHILE SUBSEQUENTLY RETRACTING THE CATHETER BY ONE CENTIMETER, THE CATHETER SUDDENLY FRACTURED. THE TECHNICIAN IMMEDIATELY APPLIED A TOURNIQUET TO THE UPPER ARM AND NOTIFIED THE INTERVENTIONAL RADIOLOGIST. THE PHYSICIAN PERFORMED AN INTERVENTIONAL RETRIEVAL PROCEDURE TO EXTRACT THE BROKEN TUBING. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23526975 ↗
• MalfunctionNov 4, 2025Backflow; Backflow

  IT WAS REPORTED THE VASCULAR PUNCTURE PROCEEDED SMOOTHLY, CONFIRMING NO ARTERIAL PENETRATION. HOWEVER, BLOOD CONTINUOUSLY OOZED FROM THE CATHETER TIP DURING CATHETER ADVANCEMENT, RESULTING IN VALVE MALFUNCTION. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468139 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, DUE TO THE NEED FOR TREATMENT OF A MALIGNANT TUMOR IN THE PATIENT'S RIGHT LUNG, A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS PLACED VIA A PERIPHERAL VEIN. ON (B)(6) 2025, A COLOR DOPPLER ULTRASOUND EXAMINATION OF THE UPPER LIMB VEINS REVEALED THROMBOSIS IN THE LEFT AXILLARY, BRACHIOCEPHALIC, AND SUBCLAVIAN VEINS, WITH SIGNIFICANT OBSTRUCTION OF THE VENOUS LUMEN. PER PHYSICIAN ORDERS, ADMINISTERED 0.4 ML SUBCUTANEOUS INJECTION OF LOW MOLECULAR WEIGHT HEPARIN CALCIUM SOLUTION EVERY 12 HOURS. CONTINUOUS MONITORING WILL BE MAINTAINED. THE CATHETER TIP POSITION IS CONFIRMED ACCURATE; CATHETER REMOVAL IS NOT INDICATED AT THIS TIME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23424893 ↗