STATLOCKRecalls & reported problems across all models

We found 23 models of STATLOCK by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 188 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2016 and Sep 23, 2026 — classified as 8 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Misconnection” (45 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

Most reported STATLOCK problems

STATLOCK models

23 models, most reported first. Each model has its own page with its reports, recalls and device details.

• STATLOCK PIC0220

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  47 reports
• STATLOCK CV0220CE

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  24 reports
• STATLOCK VPPCSP

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  24 reports
• STATLOCK PIC0222

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  18 reports
• STATLOCK VUPD1214

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  13 reports
• STATLOCK DI0120

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  9 reports
• STATLOCK CV0226

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  8 reports
• STATLOCK VUPD1012

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  7 reports
• StatLock 0684000472

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  6 reports
• STATLOCK IV0520

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  5 reports
• STATLOCK D10120CE

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  5 reports
• STATLOCK VUPD68

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  4 reports
• STATLOCK VPPDFP

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  3 reports
• STATLOCK VPPDFPCE

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  3 reports
• STATLOCK CV0321

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  2 reports
• STATLOCK NN0201

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  2 reports
• STATLOCK VUPD1416

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  2 reports
• STATLOCK IV0500

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  1 report
• STATLOCK IV0520CE

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  1 report
• STATLOCK MP0120

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  1 report
• STATLOCK NN0200

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  1 report
• STATLOCK VCDPP

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  1 report
• StatLock S04020010

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  1 report

Recent STATLOCK adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 10, 2026Contamination /Decontamination Problem

  It was reported "I just picked it up from the warehouse and noticed there was a strand of hair inside the package." No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716230 ↗
• MalfunctionAug 5, 2026Misconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136786 ↗
• MalfunctionJul 10, 2026Misconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25781953 ↗
• MalfunctionJun 29, 2026Product Quality Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE TAPE MARKINGS ARE CROOKED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25652071 ↗
• MalfunctionJun 23, 2026Misconnection

  IT WAS REPORTED THAT UNCLAMPED PICC LINE FROM ROLL TO ACCESS 4-WAY CONNECTOR. IT WAS AT THIS TIME THAT WRITER FELT 28G LINE COMPLETELY DISCONNECT FROM PINK HUB WHICH ATTACHES TO STATLOCK. LINE WAS COMPLETELY COMPROMISED SO CLINICIAN WAS IMMEDIATELY CALLED TO ATTEMPT NEW ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25600757 ↗
• MalfunctionJun 15, 2026Misconnection

  IT WAS REPORTED THAT ON MAY 22, 2026, WHILE PERFORMING ROUTINE MAINTENANCE ON A PICC LINE FOR A PATIENT, MEDICAL STAFF ATTEMPTED TO SECURE THE CATHETER USING A STATLOCK CONNECTOR. HOWEVER, THE CONNECTOR FAILED TO ENGAGE AND LOCK PROPERLY, RESULTING IN AN UNSTABLE FIXATION AND A TENDENCY FOR THE CATHETER TO LOOSEN AND SLIP OUT. A NEW, UNDAMAGED STATLOCK CONNECTOR OF THE SAME MODEL WAS IMMEDIATELY REPLACED, AND THE CATHETER WAS RE-SECURED ACCORDING TO STANDARD PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25504183 ↗
• MalfunctionMay 18, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT MULTIPLE POUCHES HAD PRINTING DEFECTS THAT IMPACTED LEGIBILITY. IT WAS REPORTED THAT THIS OCCURRED WITH 7 DEVICES. THIS REPORT COVERS ALL 7 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25208031 ↗
• MalfunctionMay 1, 2026Misassembled

  IT WAS REPORTED NURSES ROUTINELY USE STATLOCK DEVICE TO PERFORM CENTRAL VENOUS CATHETER MAINTENANCE FOR PATIENTS. AFTER OPENING THE PACKAGE IT WAS DISCOVERED THE SLIDING LOCKING ROD ON ONE SIDE WOULD NOT MOVE, PREVENTING IT FROM ALIGNING WITH THE HOLE ON THE CATHETER AND RENDERING IT UNUSABLE. AFTER REPLACING THE PRODUCT, THEY CONTINUED WITH THE PATIENT¿S CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059752 ↗
• MalfunctionMar 31, 2026Misconnection

  IT WAS REPORTED BY CUSTOMER THAT THE SLIT APPEARS SMALLER (NARROWER) THAN USUAL. THE DRAIN DOESN'T STAY IN PLACE AND THEREFORE SLIPS OUT. NO PATIENT HARM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744001 ↗
• 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 ↗
• MalfunctionMar 4, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT FOREIGN MATTER FOUND IN PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513372 ↗
• MalfunctionMar 4, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT FOREIGN MATTER FOUND IN PACKAGING. IT WAS REPORTED THIS OCCURRED WITH 3 DEVICES. THIS REPORT ADDRESSES 3 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507969 ↗
• MalfunctionFeb 24, 2026Misconnection

  IT WAS REPORTED CUSTOMER IS HAVING TROUBLE WITH HIS STATLOCK. HE STATES THAT IT HAS NOT STAYED CLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427977 ↗
• MalfunctionFeb 24, 2026Misconnection

  IT WAS REPORTED CUSTOMER IS HAVING TROUBLE WITH HIS STATLOCK. HE STATES THAT IT HAS NOT STAYED CLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427972 ↗

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