STATLOCK VPPDFPCERecalls & reported problems
Bard Access Systems, Inc. · SL PICC PLUS CRESC FOAM FIXED POST CE · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741083396), received between Jun 19, 2024 and Sep 23, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (3 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove3
- Loss of or Failure to Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Difficult to Remove
It was reported it¿s not possible to adjust the blue tabs in the middle. This means the StatLocks don¿t fit. The plaster sticks firmly to the skin, making it almost impossible to remove the dressing. No further information was provided. An exact number of occurrences or devices was not provided by the complainant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870552 ↗MalfunctionMar 24, 2026Difficult to Remove
IT WAS REPORTED DIFFICULTIES ARE ENCOUNTERED DURING REMOVAL. NO FURTHER INFORMATION WAS PROVIDED. AN EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24676903 ↗MalfunctionJun 19, 2024Loss of or Failure to Bond; Difficult to Remove; Loss of or Failure to Bond; Difficult to Remove
IT WAS REPORTED BY THE CUSTOMER THAT "STATLOCKS ADHERING TO THE 3M BORDERED DRESSINGS, I ASKED THE STAFF ON 5A TO REPORT ANY INSTANCES TO ME SO I COULD INVESTIGATE WHERE THE PREVIOUS DRESSING HAD BEEN DONE EXTERNALLY." CUSTOMER MAY NOT BE USING COMPATIBLE COMPETITOR DRESSING WITH OUR STATLOCK DRESSING TOOK ADDITIONAL 20 MINUTES TO REMOVE DRESSING AND STAT LOCK. THE FOAM BECAME IMPOSSIBLE TO REMOVE. THE ONLY WAY THE RN COULD DO WAS USE ALCOHOL WAND. THE DRESSING ALSO SEEMS TO BE MORE DIFFICULT TO REMOVE FROM THE STAT LOCK. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566840 ↗
Other DEVICE, INTRAVASCULAR CATHETER SECUREMENT devices
- STATLOCK PIC0220Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT47 reports
- STATLOCK VPPCSPBard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT24 reports
- STATLOCK CV0220CEBard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT24 reports
- STATLOCK PIC0222Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT18 reports
- Catheter Stabilization Device NG0120C. R. Bard, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT1 death13 reports
- STATLOCK VUPD1214Bard Access Systems, Inc. · DEVICE, INTRAVASCULAR CATHETER SECUREMENT13 reports
- BD PhaSeal™ Optima Infusion Clamp M25-O 515085Becton Dickinson Pen Limited · DEVICE, INTRAVASCULAR CATHETER SECUREMENT12 reports
- Grip-Lok 3601CVCTidi Products, LLC · Device, Intravascular Catheter Securement12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.