Grip-Lok 3601CVCRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00618125135011), received between Jul 5, 2022 and May 15, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Contamination” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Contamination

  DURING THE ACCEPTANCE INSPECTION, NON-CONFORMING PRODUCTS WERE DETECTED. FOREIGN OBJECT DEBRIS FOUND IN 12 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191961 ↗
• MalfunctionMar 22, 2024Contamination; Contamination

  COMPLIANT WAS REPORTED BY A DISTRIBUTOR IN JAPAN FOR A NONCONFORMANCE IDENTIFIED DURING INCOMING INSPECTION AT THEIR FACILITY IN JAPAN. DETAILS OF NONCONFORMITY: SEALING FAILURE - QTY: 20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965105 ↗
• MalfunctionMar 22, 2024Contamination; Contamination

  COMPLIANT WAS REPORTED BY A DISTRIBUTOR IN JAPAN FOR A NONCONFORMANCE IDENTIFIED DURING INCOMING INSPECTION AT THEIR FACILITY IN JAPAN. DETAILS OF NONCONFORMITY: NOTCH IN PACKAGING IS MISALIGNED - QTY: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965084 ↗
• MalfunctionMar 15, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  COMPLAINT WAS RECEIVED VIA THE IMPORTER FOR ISSUES EXPERIENCED BY THEIR CUSTOMER. END USER REPORTED ISSUES WITH THE GRIP-LOK 3601CVC USED TO SECURE CVAD DEVICES MAKING BOTH THE DRESSING CHANGE AND THE REMOVAL CHALLENGING AND RISKY TO THE PATIENTS: 1. ON DOING A DRESSING CHANGE, STAFF HAD A HARD TIME SEPARATING THE CVAD FROM THE ADHESIVE STRIP. THE STAFF ARE ALWAYS CONCERNED ABOUT THE CVAD MOVING INTO OR OUT OF THE PATIENT. 2. ON TRYING TO REMOVE THE DEVICE WHEN THE CVAD IS READY TO BE REMOVED, WE USED ALCOHOL TO ASSIST IN THE REMOVAL OF THE GRIP-LOK DEVICE. ON A SUBSEQUENT DRESSING CHANGE ON ANOTHER PATIENT THE SAME DAY, WE TRIED TO CHANGE OUR PROCESS TO MAKE THE PROCEDURE SAFER. WE OPENED THE VELCRO TAB FIRST, WE USED AN ADHESIVE REMOVER UNDER THE ADHESIVE STRIP, AND THEN WE CLEANED AND THEN WE ATTEMPTED TO REMOVE THE SECUREMENT DEVICE. IT WAS STILL DIFFICULT TO REMOVE THE CVAD FROM THE ADHESIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918093 ↗
• MalfunctionMar 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  MCA0767 RECURRING ISSUE. PATIENT WAS ABLE TO EASILY REMOVE HIS PICC LINE AFTER IT WAS SECURED WITH THE NEW MEDIUM UNIVERSAL PICC AND CVC SECUREMENT DEVICE PATIENT OBSERVED TO GRAB LINE, PULLED AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18870793 ↗
• MalfunctionMar 8, 2024Mechanical Problem; Mechanical Problem

  COMPLAINT#: (B)(4) THIS PRODUCT DOES NOT HOLD THE PICC LINE SECURE IN PLACE THE LINE WAS STILL ABLE TO MOVE. RISK OF PICC LINE TRAVELING. RECURRING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18870783 ↗
• MalfunctionMar 10, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED BY VYGON, TIDI'S MEDICAL DEVICE DISTRIBUTOR IN ITALY: ¿THE DEVICE IN QUESTION WAS SO ATTACHED TO BOTH THE SKIN AND THE MIDLINE (CATHETER) THAT TWO OPERATORS WERE REQUIRED TO REMOVE IT WITHOUT CAUSING INJURY TO THE SKIN AND DISPLACING THE CVC. IT WAS ALSO VERY DIFFICULT TO REPOSITION IT CORRECTLY¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526630 ↗
• MalfunctionJan 19, 2023Contamination; Contamination

  COMPLIANT WAS REPORTED BY A DISTRIBUTOR IN JAPAN FOR A NONCONFORMANCE IDENTIFIED DURING INCOMING INSPECTION AT THEIR FACILITY IN JAPAN. DETAILS OF NONCONFORMITY: STERILE BAG HAS HOLES - QTY: 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16208957 ↗
• MalfunctionJan 19, 2023Contamination; Contamination

  COMPLIANT WAS REPORTED BY A DISTRIBUTOR IN JAPAN FOR A NONCONFORMANCE IDENTIFIED DURING INCOMING INSPECTION AT THEIR FACILITY IN JAPAN. DETAILS OF NONCONFORMITY: NOT SEALED - QTY: 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16208907 ↗
• MalfunctionJan 19, 2023Contamination; Contamination

  COMPLIANT WAS REPORTED BY A DISTRIBUTOR IN JAPAN FOR A NONCONFORMANCE IDENTIFIED DURING INCOMING INSPECTION AT THEIR FACILITY IN JAPAN. DETAILS OF NONCONFORMITY: SEALING FAILURE - QTY: 19.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16208723 ↗
• MalfunctionNov 21, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY VYGON, TIDI'S MEDICAL DEVICE DISTRIBUTOR IN ITALY: THE FIXATION DEVICE DISLODGED FROM THE PATIENT'S SKIN CAUSING THE ACCIDENTAL REMOVAL OF THE DEVICE. THE SAME ISSUE REGARDING THE POOR ADHESION OF THE DEVICE TO THE SKIN AND THE INADEQUATE FIXATION ABILITY OF THE CVC WAS REPEATEDLY REPORTED BY OPERATORS. CONSEQUENCE: IMPLANTATION OF A NEW CVC. THIS IS THE FIRST TIME WE ARE AWARE OF PROBLEMS WITH THE 3601CVC IN PISA, NOR HAVE WE EVER VISITED THE CLIENT TO ASCERTAIN IF THEY HAD PROBLEMS. WE'LL SCHEDULE A MEETING WITH THE CUSTOMER TO DISCUSS ABOUT BEST PRACTICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834567 ↗
• MalfunctionJul 5, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED BY VYGON, TIDI'S MEDICAL DEVICE DISTRIBUTOR IN ITALY, THAT: "THESE DEVICES ARE NOT EASY TO USE, AS THE GLUE THAT IS SUPPOSED TO STABILISE THE CVC TO THE DEVICE IS VERY STRONG AND IT IS DIFFICULT TO REMOVE IT AND ALSO CAUSES ADHESION WITH STERILE GLOVES. THE EVENT DOES NOT SEEM TO BE RELATED TO A POTENTIAL PRODUCT NONCONFORMITY, IT SEEMS TO BE THE USUAL USABILITY ISSUE." REPORT IS BEING SUBMITTED BECAUSE EXCESSIVE ADHESIVE, RESULTING IN THE LINES GETTING STUCK IN/TO THE DEVICE MAY RESULT IN UNINTENDED REMOVAL OF THE MEDICAL LINES. THESE EVENTS MAY INTERRUPT PATIENT TREATMENT AND MAY CONTRIBUTE TO PATIENT INJURY. AT THIS TIME, THERE IS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915885 ↗