Groshong Catheter 7717305Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 00801741087035), received between Nov 11, 2015 and Sep 14, 2026 — classified as 16 injuries, 104 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (63 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 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Fluid/Blood Leak

  It was reported that the head nurse reported that after inserting a catheter for a patient, pinholes appeared at the connection between the connector and the catheter, resulting in fluid leakage and seepage. The patient¿s family became very upset, but the clinical representative successfully calmed them down. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756481 ↗
• MalfunctionJul 10, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25781938 ↗
• MalfunctionJun 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS LEFT IN PLACE FOR THE PATIENT¿S TREATMENT. AT 8:00 A.M. ON MARCH 30, FLUID LEAKAGE WAS DETECTED FROM THE PICC LINE DURING USE. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537338 ↗
• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2026, A PEDIATRIC PATIENT HAD A CENTRAL VENOUS CATHETER INSERTED VIA A PERIPHERAL LINE FOR TREATMENT PURPOSES. ON MARCH 19, IT WAS DISCOVERED THAT THE CATHETER CONNECTOR HAD BROKEN, RENDERING THE CATHETER UNUSABLE. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537320 ↗
• MalfunctionMay 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT HAD A CATHETER INSERTED ON (B)(6). ON (B)(6) THE CATHETER DISLODGED FROM THE EXTENSION TUBE. AFTER REPAIRING THE CATHETER, A NEW PRESSURE-RELIEF SLEEVE WAS REPLACED AND RECONNECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075897 ↗
• MalfunctionMay 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT HAD A CATHETER INSERTED ON MARCH 23; ON APRIL 8, THE CATHETER DISLODGED FROM THE DECOMPRESSION SLEEVE, AND A NEW CATHETER WAS INSERTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057251 ↗
• MalfunctionApr 28, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A PICC ON (B)(6) 2026, AND THE CATHETER WAS FOUND TO BE LEAKING LESS THAN A MONTH AFTER INSERTION. NEW CATHETER INSERTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019079 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEPARTMENT INSERTED CATHETER INTO THE PATIENT. NO ABNORMALITIES WERE DETECTED DURING THE PRE-FILLING OF THE CATHETER IN THE PREPARATION PHASE. THE ENTIRE INSERTION PROCESS PROCEEDED SMOOTHLY. AFTER CONNECTING THE CONNECTOR, BLOOD WAS SUCCESSFULLY DRAWN BACK. IN THE AFTERNOON, AFTER THE PATIENT COMPLETED THE FLUID FLUSH, FLUID WAS OBSERVED UNDER THE PROTECTIVE FILM. UPON REMOVING THE FILM, LEAKAGE WAS FOUND NEAR THE PRESSURE-RELIEF SLEEVE. THE CATHETER WAS WITHDRAWN 4 CM, TRIMMED, AND CONTINUED TO BE USED BY THE PATIENT. THE CATHETER IS SCHEDULED TO BE REMOVED UPON COMPLETION OF THE EXPECTED TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24959824 ↗
• MalfunctionApr 6, 2026Fluid/Blood Leak

  IT WAS REPORTED, DURING PICC PLACEMENT FOR A PATIENT IN OUR INFUSION SUITE, WHILE USING A PRE-FILLED PUSH CATHETER, A CATHETER WAS FOUND TO BE LEAKING, WHICH WAS IMMEDIATELY CUT AND SECURED. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION: REPLACED WITH A NEW CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795148 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE DEPARTMENT INSERTED A CATHETER INTO THE PATIENT. DURING THE PREPARATORY PHASE, NO ABNORMALITIES WERE DETECTED IN THE PRE-FILLED CATHETER. THE ENTIRE CATHETERIZATION PROCESS PROCEEDED SMOOTHLY. AFTER ATTACHING THE CONNECTOR, BLOOD RETURN WAS SUCCESSFUL. HOWEVER, DURING FLUSHING, LEAKAGE WAS OBSERVED AT THE CATHETER BODY. CONCERNED THAT THE PORTION ALREADY INSERTED INTO THE BODY MIGHT ALSO BE COMPROMISED, THE CATHETER WAS SUBSEQUENTLY REMOVED AND REINSERTED ON THE OPPOSITE SIDE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621342 ↗
• MalfunctionFeb 19, 2026Misassembled; Product Quality Problem

  IT WAS REPORTED THAT UPON OPENING THE PACKAGING, IT WAS DISCOVERED THAT PORTIONS OF THE CATHETER AND GUIDEWIRE HAD BECOME DISLODGED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387662 ↗
• MalfunctionJan 26, 2026Product Quality Problem

  IT WAS REPORTED THAT A WEAKENED AREA WITH SUSPECTED INDENTATION WAS OBSERVED AT THE 39-41 CM MARK OF A NEWLY REMOVED PICC CATHETER. THE NEWLY REMOVED CATHETER WAS USED ON THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 18-JAN-2026: CATHETER WAS NEWLY REMOVED FROM PACKAGING. A NEW CATHETER WAS INSERTED INTO THE PATIENT AFTER UNDERGOING STANDARD PRE-FLUSHING AND TRIMMING PROCEDURES FOLLOWING REMOVAL FROM ITS PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24182595 ↗
• MalfunctionJan 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRE-FLUSHING OF A NEWLY UNPACKED CATHETER, A RUPTURE AND FLUID LEAKAGE WERE DISCOVERED APPROXIMATELY 3 CM FROM THE DISTAL END, NEAR THE LATERAL VALVE POSITION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178190 ↗
• MalfunctionJan 12, 2026Fluid/Blood Leak

  IT WAS REPORTED, A PERIPHERAL-TO-CENTRAL CATHETER (3F) WAS INTENDED FOR PLACEMENT IN THE PEDIATRIC PATIENT. UPON OPENING THE PACKAGE AND TESTING WITH A SYRINGE, LEAKAGE WAS DETECTED IN THE PERIPHERAL-TO-CENTRAL CATHETER (3F), AND IT WAS NOT USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037524 ↗
• MalfunctionDec 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PEDIATRIC PATIENT, DIAGNOSED WITH ACUTE LYMPHOBLASTIC LEUKEMIA, UNDERWENT CHEMOTHERAPY VIA A PICC LINE. PRIOR TO INFUSION, THE CATHETER WAS FLUSHED USING A PRE-FLUSH CATHETER. NO BLOOD RETURN WAS OBSERVED UPON ASPIRATION. HOWEVER, AFTER DRUG ADMINISTRATION, FLUID WAS DETECTED SEEPING BENEATH THE ADHESIVE FILM. CATHETER MAINTENANCE WAS PERFORMED, DURING WHICH DAMAGE AND LEAKAGE WERE IDENTIFIED AT THE EXPOSED DISTAL END OF THE CATHETER. THE PICC PLACEMENT NURSE WAS CONSULTED. FOLLOWING ASSESSMENT, THE DAMAGED SECTION OF THE CATHETER WAS TRIMMED. SUBSEQUENT MAINTENANCE REVEALED NO FURTHER LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919148 ↗
• MalfunctionDec 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT, DIAGNOSED WITH ACUTE LYMPHOBLASTIC LEUKEMIA, WAS UNDERGOING CHEMOTHERAPY VIA A PICC LINE. DURING INFUSION MONITORING, A SMALL AMOUNT OF SEROUS FLUID WAS OBSERVED BENEATH THE DRESSING. CATHETER MAINTENANCE WAS PERFORMED, DURING WHICH DAMAGE AND LEAKAGE WERE DETECTED AT THE EXPOSED DISTAL END OF THE CATHETER. THE PICC PLACEMENT NURSE WAS CONSULTED. FOLLOWING ASSESSMENT, THE LEAKING SEGMENT OF THE PICC CATHETER WAS TRIMMED, AND SUBSEQUENT MAINTENANCE REVEALED NO FURTHER LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908947 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT UNDERWENT CATHETER PLACEMENT ON SEPTEMBER 5, WITH CATHETER RUPTURE OCCURRING ON NOVEMBER 1. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23832821 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT UNDERWENT CATHETER PLACEMENT ON FEBRUARY 18, WITH CATHETER RUPTURE ON OCTOBER 13. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23832691 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT RECEIVED CATHETER PLACEMENT ON (B)(6), EXPERIENCING CATHETER RUPTURE IN (B)(6). NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23832603 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT, A CHILD, WITH SHORT BOWEL SYNDROME, PRIMARILY RECEIVING PARENTERAL NUTRITION VIA A PICC LINE TO REDUCE INTESTINAL BURDEN AND GRADUALLY RESTORE BOWEL FUNCTION. ON (B)(6) 2025, THE PATIENT UNDERWENT A ¿PICC LINE PLACEMENT PROCEDURE¿ UNDER GENERAL ANESTHESIA IN THE INTERVENTIONAL SUITE. ON (B)(6) 2025, THE CATHETER RUPTURED, AND A REPLACEMENT CONNECTOR WAS INSERTED.

  Patient problems: Insufficient Information

  MAUDE report 23832587 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED DURING THE PATIENT'S INITIAL CATHETER PLACEMENT, THE CATHETER FRACTURED EXTERNALLY. WITH 29 CM RETAINED INTERNALLY AND 6 CM EXTERNALLY EXPOSED, THE CATHETER TIP POSITION WAS CONFIRMED POST-INSERTION. WHILE THE NURSE WAS WITHDRAWING THE GUIDEWIRE FROM THE CATHETER, THE CATHETER FRACTURED COMPLETELY AT THE 39 CM MARK, 10 CM FROM THE PUNCTURE SITE. THE CATHETER WAS NOT IMMEDIATELY REMOVED. AFTER TRIMMING THE CATHETER AS STANDARD PROCEDURE, IT WAS LEFT IN PLACE. THE CATHETER'S FUNCTIONALITY REQUIRES ONGOING MONITORING. THE CATHETER FRACTURED DURING INSERT, SPECIFICALLY WHEN THE GUIDEWIRE WAS WITHDRAWN AFTER CATHETER PLACEMENT; SINCE THE FRACTURE OCCURRED BEYOND THE INTENDED CLIPPING SITE, THE CATHETER REMAINED IN THE PATIENT'S BODY AND CONTINUED TO BE USED AFTER CLIPPING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704949 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A CATHETER RUPTURE AND LEAKAGE OCCURRED AT THE CONNECTION POINT BETWEEN THE PICC CATHETER AND THE PRESSURE-RELIEF SLEEVE. THE CATHETER WAS NOT REMOVED AT THIS TIME. THE ISSUE WAS ADDRESSED BY TRIMMING THE CATHETER AND REPLACING THE PRESSURE-RELIEF SLEEVE. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES ALL FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647347 ↗
• MalfunctionNov 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID LEAKAGE FROM THE CATHETER APPROXIMATELY 1 CM BELOW THE TRICUSPID VALVE AT THE 3F LEVEL RESULTED IN CATHETER PLACEMENT FAILURE. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633398 ↗
• MalfunctionNov 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED 11/19/2025: THE DAMAGED SECTION OF THE CATHETER HAS BEEN CUT OUT AND REMOVED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605065 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2025, PRIOR TO SURGICAL PLACEMENT OF A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER IN A PEDIATRIC PATIENT, FLUSHING REVEALED CATHETER DAMAGE AND LEAKAGE. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER TO COMPLETE THE PLACEMENT PROCEDURE. NO FURTHER INFORMATION AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596427 ↗