Grip-LokRecalls & reported problems across all models
Tidi Products, LLC · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 11 models of Grip-Lok by Tidi Products, LLC in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Jul 5, 2022 and May 15, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Grip-Lok problems
Device problems
- Loss of or Failure to Bond10
- Contamination7
- Difficult or Delayed Positioning3
- Mechanical Problem3
- Difficult or Delayed Separation2
- Patient Device Interaction Problem1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
Grip-Lok models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Grip-Lok 3601CVCDevice, Intravascular Catheter Securement12 reports
- Grip-Lok 3300M-10PKDevice, Intravascular Catheter Securement3 reports
- Grip-Lok 3200SGastrointestional Tube Holder2 reports
- Grip-Lok 3300MWADevice, Intravascular Catheter Securement2 reports
- Grip-Lok 3604MCS-TA-1Device, Intravascular Catheter Securement2 reports
- Grip-Lok 3400LGastrointestional Tube Holder1 report
- Grip-Lok 3400LFCHolder, Ureteral Catheter1 report
- Grip-Lok 3400LFC-10PKHolder, Ureteral Catheter1 report
- Grip-Lok 2200NUZADevice, Intravascular Catheter Securement1 report
- Grip-Lok 3300MW-TA-3Device, Intravascular Catheter Securement1 report
- Grip-Lok 3300MART-KIT-2Device, Intravascular Catheter Securement1 report
Recent Grip-Lok adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMay 15, 2026Unsealed Device Packaging
DURING THE ACCEPTANCE INSPECTION, NON-CONFORMING PRODUCTS WERE DETECTED. INCOMPLETE SEAL ON MULTIPLE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191909 ↗MalfunctionDec 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
AMAZON REVIEW: I BOUGHT THESE TO HOLD MY CATH TUBING IN PLACE, SPENT OVER $(B)(6) FOR 10 OF THEM AND THEY DON'T WORK, WITHIN AN HOUR IT WASN'T STUCK TO MY SKIN ANYMORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21020198 ↗MalfunctionDec 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
AMAZON REVIEW: THIS EXPENSIVE CATHETER STABILIZATION DEVICE COMES LOOSE AFTER A FEW DAYS. IT IS VERY DIFFICULT TO REMOVE THE CATHETER FROM THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21020188 ↗MalfunctionDec 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
AMAZON REVIEW: I USED THE 1ST OF THESE YESTERDAY; IT DIDN'T EVEN LAST 12 HOURS BEFORE IT TOTALLY CAME OFF. I EVEN USED A BARRIER CREAM THAT IS SUPPOSED TO HELP IT STICK BETTER. TODAY I DECIDED I'D LET IT SET LONGER BEFORE I HOOKED MY CATHETER TUBES IN IT. WITHIN AN HOUR, IT WAS ALREADY COMING LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21020174 ↗MalfunctionJul 22, 2024Mechanical Problem; Mechanical Problem
AMAZON REVIEW: THE LAST 2 TIMES I'VE ORDERED THESE FOR MY SON THEY HAVE ALL BEEN BAD. WE NORMALLY GET 3 TO 5 DAYS EVEN WITH BATHING OR SWIMMING. WE GET ABOUT A MONTH FROM 1 ORDER. I'VE HAD TO USE 5 IN 9 DAYS AS THEY BARELY STICK TO HIS SKIN AND THE VELCRO BARELY HOLDS HIS TUBE. IF THE NEXT BATCH IS BAD I'M GOING ELSEWHERE. WASTED MONEY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19796514 ↗MalfunctionJun 7, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED BY THE CUSTOMER: "I'M 71 YEARS OLD, AND I CLEAN AND DRY MY LEG CORRECTLY, SO IT'S NICE AND DRY. I HAVE NO HAIR ON THAT PART OF MY BODY BECAUSE, LUCKY FOR ME, I'M NOT A HAIRY PERSON. JUST TO CLARIFY IT FOR YOU, THE GRIP-LOK REMAINS ON MY LEG BEAUTIFULLY, BUT THE WHITE LAYER ON TOP THAT SECURES THE CATHETER TUBE COMES OFF WITHIN A FEW DAYS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19491256 ↗MalfunctionApr 10, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
CUSTOMER REPORTED VIA HUBSPOT: I ORDERED A BOX OF GRIP LOKS SZ LARGE ONLINE THEY ARE NOT STICKING THEY FALL OFF OVERNIGHT. I REALLY NEEDED THESE TO KEEP MY TUBE IN PLACE WHILE I WAIT ON SURGERY. CAN YOU HELP ME THESE ARE DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19082841 ↗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 ↗MalfunctionFeb 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED BY A DISTRIBUTOR THAT THAT END USER IS FINDING PRODUCT DOES NOT STAY ADHERED TO PATIENTS SKIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18647503 ↗MalfunctionJun 15, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
5/19/23-LK MCARTHUR COMPLAINT #: (B)(4) GRIP-LOK NOT SECURELY TUBES. HAVE HAD 2 INCIDENTS OF ABDOMINAL TUBES FALLING OUT AND 1 CHEST TUBE FALLING OUT. THE TUBES WERE NOT IN FOR LONGER THAN 2 DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17140075 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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