STATLOCK VPPCSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741083365), received between May 24, 2017 and Jun 29, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJan 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WITH LACERATION ASSOCIATED WITH THE USE OF THE MEDICAL DEVICE. THE HEAD NURSE REPORTS THAT THE DEVICE REMAINED IN PLACE FOR 6 DAYS, SINCE THE PATIENT ONLY PRESENTED MILD DISCOMFORT AND DID NOT PAY ATTENTION TO THEM. THE LACERATION IS SHAPED IN LINE WITH THE CONTOUR OF THE DEVICE. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: Discomfort

  MAUDE report 23994274 ↗
• MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING THE CARE ROUTINE, IT WAS OBSERVED THAT THE STAT LOCK DETACHED FROM THE FIXATION ADHESIVE, RESULTING IN THE CATHETER EXTERIORIZATION. THE DRESSING WAS WELL POSITIONED, WITH AN INTACT DRESSING, WITH NO SIGNS OF TRACTION OR MOISTURE. ON (B)(6) 2025, THE STAT LOCK AND DRESSING WERE CHANGED. ON (B)(6) 2025 THE DRESSING WAS INTACT, DRY AND WELL FIXED, BUT THE PART OF THE STAT LOCK THAT ACCOMMODATES THE CATHETER DETACHED FROM THE ADHESIVE FIXATION AND PULLED THE CATHETER, RESULTING IN THE LOSS OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417734 ↗
• MalfunctionSep 19, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER "4-YEAR OLD FEMALE PATIENT IN PICC PROGRAM OUTPATIENT CLINIC IS A CARRIER OF CATHETER PICC 4 FR BILUMEN IN RIGHT ARM WITH DATE OF INSERTION OF (B)(6) 2024, COMES IN FOLLOW UP AND HEALING OF THE CATHETER BY THE EXTERNAL CONSULTATION, TODAY CONSULTS FOR PRESENTING SENSATION OF ITCHING, THE GIRL SCRATCHES; ACCORDING TO COMMENTS OF CAREGIVER (GRANDMOTHER) IS OBSERVED DEVICE COVERED WITH TRANSPARENT DRESSING WITH GREAT MOISTURE, IRRITATED SKIN, AND DISPLACED DEVICE 10 CM. WITH A CLEAN TECHNIQUE SHE REMOVED THE TRANSPARENT DRESSING AND OBSERVED MARSI WITH LOSS OF SKIN INTEGRITY, SO THE CATHETER WAS REMOVED. IT SHOULD BE NOTED THAT IN HEALING PERFORMED ON (B)(6) 2024, SKIN TARGET LESION WAS OBSERVED AT THE LEVEL OF THE STABILIZER, IS COVERED WITH GAUZE TRYING TO ISOLATE THE AFFECTED SKIN OF THE STABILIZER ADHESIVE TO MITIGATE THE PROGRESSION OF THE INJURY. REMOVAL OF CATHETER AND IMPATIENT TO SCHEDULE NEW PICC CATHETER INSERTION. THERE WAS NO DIFFICULTY REMOVING THE CATHETER AND NO DAMAGE/DEFECT FOUND ON THE CATHETER."

  Patient problems: Abrasion; Local Reaction; Localized Skin Lesion; Skin Inflammation/ Irritation

  MAUDE report 20256413 ↗
• MalfunctionJun 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT IS REPORTED THAT DURING THE HEALING PROCESS OF EXTRAVASCULAR DEVICES, IMMEDIATE DAMAGE OF THE STATLOCK INPUT THAT SERVES TO PREVENT ACCIDENTAL DISPLACEMENT OF VASCULAR ACCESS IS EVIDENCED, A SITUATION THAT HAD NEVER OCCURRED BEFORE. NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476820 ↗
• MalfunctionJul 30, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE BONDING CAUSED THE STABILIZER TO BREAK. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED STATED WITHIN COMPLAINT COMMENTS ON 03.AUG.2020: "THE HEALTHCARE STAFF WAS PERFORMING THE CURING TO THE PATIENT AND AT THE MOMENT OF PREPARING THE DEVICE AND REMOVING THE PAPER THAT IT BRINGS, CONSIDERING THAT IT WAS TOO ADHERED TO ITS PACKAGING, IT CAUSES THE DEVICE TO BREAK. THE DAMAGE WAS IN THE PACKAGE (NOT IN THE STATLOCK). THERE IS ADHESIVE IN THE PACKAGE, THAT MAKES MORE DIFFICULT THE MOMENT OF OPENING IT TO USE THE DEVICE. THE ISSUE WAS NOTICED PRIOR DEVICE USE. THERE WAS NO PATIENT INVOLVEMENT."

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10348015 ↗
• MalfunctionApr 20, 2020Misconnection; Misconnection

  IT WAS REPORTED THAT THE PORTION WHERE THE CATHETER LOCKS ON THE ADHESIVE HAD THE FLAP BROKEN, SO THE CATHETER WAS LOOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9979808 ↗
• MalfunctionApr 2, 2020Misconnection; Misconnection

  IT WAS REPORTED THAT THE DEVICE PRESENTED DIFFICULTY DURING ITS CLOSURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9916789 ↗
• MalfunctionMar 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED PER RECEIVED MEDWATCH "PLASTIC WINGS OF STAT LOCK LIFTING OFF WHITE STICKER."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848489 ↗
• MalfunctionMar 12, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK DEVICE DETACHED FROM THE PATIENT'S SKIN EVEN WITH PROPER FIXATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9824963 ↗
• MalfunctionJan 31, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PEELING PRODUCT FROM PATIENT'S SKIN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9655488 ↗
• MalfunctionNov 25, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT WHEN OPENING THE PRODUCT IT WAS VERIFIED THAT THE ADHESIVE PART OF IT WAS NOT ADHERING, THUS MAKING ITS USE IMPOSSIBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9370510 ↗
• MalfunctionOct 31, 2019Misconnection; Material Twisted/Bent; Misconnection; Material Twisted/Bent

  IT WAS REPORTED THAT THE LOCK WAS BROKEN. PICC STATLOCK EXCHANGED FOR STABILIZATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261334 ↗
• MalfunctionOct 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH REPORT, "UPON PATIENT'S ARRIVAL (INFANT/TODDLER) TO DIALYSIS CARE TAKER REPORTS THE PLASTIC UNIT OF THE STATLOCK STABILIZATION DEVICE (PLASTIC PART OF UNIT THAT LOCKS ONTO HD CVC WINGS) HAD COMPLETELY DISCONNECTED FROM THE CRESCENT FOAM PAD OF DEVICE. THE FOAM PAD OF THE DEVICE REMAINED ON THE PATIENT'S CHEST. IT WAS NOTED THE PATIENT'S HEMODIALYSIS CATHETER HAD MIGRATED OUT OF HIS CHEST WITH CUFF OF CATHETER EXPOSED. SECUREMENT DEVICE WAS NOT EFFECTIVE IN SECURING THE HEMODIALYSIS CATHETER. "

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194239 ↗
• MalfunctionOct 11, 2019Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component

  IT WAS REPORTED WHEN THE PRODUCT WAS OPENED IT WAS "VERIFIED THAT THE STICKING WAS NOT ADHERING, MAKING IT IMPOSSIBLE TO USE." DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9179875 ↗
• MalfunctionJul 18, 2019Defective Component; Connection Problem

  IT WAS REPORTED THAT THE CONNECTOR TO FIXATE THE CATHETER WAS DEFECTIVE. (B)(6) 2019: CUSTOMER REPORTS: "THE CONNECTION DID NOT HOLD THE CATHETER". IT WAS STATED THAT THIS OCCURRED WITH TWO STATLOCKS. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804271 ↗
• MalfunctionJul 18, 2019Defective Component; Positioning Problem

  IT WAS REPORTED THAT THE CONNECTOR TO FIXATE THE CATHETER WAS DEFECTIVE. (B)(6) 2019: CUSTOMER REPORTS: "THE CONNECTION DID NOT HOLD THE CATHETER". IT WAS STATED THAT THIS OCCURRED WITH TWO STATLOCKS. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804267 ↗
• MalfunctionJul 10, 2018Break

  IT WAS REPORTED THAT THE FIXATION DEVICE FOR THE CATHETER WAS DAMAGED/BROKEN. NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7674602 ↗
• MalfunctionJan 12, 2018Failure To Adhere Or Bond

  IT WAS REPORTED THE ADHESION SITE ON THE STATLOCK WAS NOT STICKY, THUS THE DEVICE COULD NOT BE FIXED ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7187783 ↗
• MalfunctionJan 12, 2018Failure To Adhere Or Bond

  IT WAS REPORTED THE ADHESION SITE ON THE STATLOCK WAS NOT STICKY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7187670 ↗
• MalfunctionAug 16, 2017Break

  IT WAS REPORTED ON (B)(6) 2017 THAT THE CLEAR PLASTIC SECUREMENT DEVICE THAT HOLDS THE BUTTERFLY WINGS ON THE PICC CAME APART FROM THE WHITE FOAM ADHESIVE ON APPLICATION TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6799207 ↗
• MalfunctionAug 11, 2017Defective Alarm; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE IN THE SEAL. NO OTHER INFORMATION WAS REPORTED. 10/10/2017- CUSTOMER CONFIRMED, DEFECT WAS IN THE "BUTTERFLY WING" OF THE DEVICE (THE WAY THE STATLOCK DEVICE CLOSED).

  Patient problems: No Patient Involvement

  MAUDE report 6788659 ↗
• MalfunctionJul 7, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE ACRYLIC FIXING WAS DETACHED FROM THE ADHESIVE TAPE AND NOT SECURING THE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6692570 ↗
• MalfunctionMay 24, 2017Disconnection

  IT WAS REPORTED THAT THE PART THAT CONNECTS THE CLAMP DOESN'T WORK. IT IS DISCONNECTING AND NOT HOLDING THE PICC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6589647 ↗