STATLOCK CV0220CERecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741081507), received between Mar 5, 2020 and Sep 10, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Misconnection” (13 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.

• 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 ↗
• 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 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 ↗
• InjuryJan 7, 2026Component Missing

  IT WAS REPORTED ON DECEMBER 15TH AT APPROXIMATELY 2:00 PM, AFTER PLACING A MEDIUM-TO-LONG CATHETER IN THE PATIENT, THE FIXATION DEVICE WAS REQUIRED FOR STABILIZATION. UPON OPENING THE PACKAGING, IT WAS DISCOVERED THAT THE FIXATION DEVICE WAS MISSING. AN IMMEDIATE REPLACEMENT WAS MADE, RESULTING IN A DELAY IN THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996364 ↗
• MalfunctionDec 31, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING PICC MAINTENANCE FOR THE PATIENT, THE ADHESIVE BACKING OF THE CATHETER HOLDER PROVED INEFFECTIVE AT SECURING THE CATHETER. USE WAS IMMEDIATELY DISCONTINUED, AND A NEW CATHETER HOLDER WAS APPLIED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23937383 ↗
• MalfunctionDec 10, 2025Misconnection; Misconnection

  IT WAS REPORTED ON (B)(6) 2025. THE PATIENT, BEDRIDDEN DUE TO LONG-TERM SEQUELAE OF CEREBRAL INFARCTION, HAD A PERIPHERAL-TO-CENTRAL VENOUS CATHETER (PICC) IN PLACE. UPON OPENING THE OUTER PACKAGING, IT WAS DISCOVERED THAT ONE SIDE OF THE CLASP WAS MALFUNCTIONING AND UNABLE TO SECURE THE CATHETER. A NEW PERIPHERAL-TO-CENTRAL VENOUS CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767587 ↗
• MalfunctionNov 25, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT NURSE PERFORMED ROUTINE MAINTENANCE ON THE PATIENT'S PICC LINE. AFTER CONFIRMING NO ABNORMALITIES WITH THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC), SHE ENTERED THE STERILE FIELD. WHILE SECURING THE PICC WITH ADHESIVE TAPE, THE NURSE DISCOVERED THE CLAMP COULD NOT SECURE THE CATHETER. SHE IMMEDIATELY CHANGED HER STERILE GLOVES, REPLACED THE PICC, AND SUCCESSFULLY SECURED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645910 ↗
• MalfunctionJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETERIZATION CLINIC NURSE WAS PERFORMING MAINTENANCE ON A PATIENT'S PICC CATHETER AND FOUND THAT THE CATHETER RETAINER HAD NO ADHESIVE AND COULD NOT BE SECURED; THE OPERATION WAS COMPLETED BY REPLACING IT WITH A STATLOCK CATHETER RETAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358222 ↗
• MalfunctionJun 2, 2025Misconnection; Misconnection

  IT WAS REPORTED THAT THE STATLOCK WAS FOUND TO HAVE A LATCH THAT COULD NOT BE SECURELY FASTENED, MAKING IT IMPOSSIBLE TO FIX THE CATHETER IN PLACE DURING USE. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES ALL FIVE DEVICES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124694 ↗
• MalfunctionMay 22, 2025Misconnection; Misconnection

  IT WAS REPORTED, CLIP/BUCKLE DOES NOT STICK WHEN IN USE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071722 ↗
• MalfunctionMay 9, 2025Misconnection; Misconnection

  IT WAS REPORTED, AT 9:00 A.M., WHILE PERFORMING PICC MAINTENANCE ON A PATIENT, A NURSE FOUND THAT THE CLIP ON ONE SIDE OF THE PERIPHERAL CATHETER CENTRAL VENOUS CATHETER WAS NOT SECURE. THE NURSE IMMEDIATELY REPLACED THE PERIPHERAL CATHETER CENTRAL VENOUS CATHETER WITH A NEW ONE, SUCCESSFULLY COMPLETED THE OPERATION, AND REPORTED THE EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993819 ↗
• MalfunctionMar 5, 2025Misconnection; Detachment of Device or Device Component; Misconnection; Detachment of Device or Device Component

  IT WAS REPORTED THE STATLOCK JUST OPENED AND CAME APART. ADDITIONAL INFORMATION RECEIVED 02/26/2025: IT WAS REPORTED THERE IS NO CATHETER DETACHMENT AND THERE WAS NO NEGATIVE IMPACT OR DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529831 ↗
• MalfunctionDec 9, 2024Misconnection; Misconnection

  IT WAS REPORTED THAT ON (B)(6) 2024 AT 9:00 A.M. THE NURSE WAS PERFORMING MAINTENANCE ON A PERIPHERALLY CANNULATED CENTRAL VENOUS CATHETER FOR A PATIENT WHEN SHE OPENED IT AND FOUND THAT THE CATHETER SECURING DEVICE WAS UNABLE TO SECURE THE CATHETER AND THAT THE CATHETER WAS DISLOCATED; THE CATHETER WAS IMMEDIATELY REMOVED AND RE-IMPLANTED INTO THE PERIPHERALLY CANNULATED CENTRAL VENOUS CATHETER AFTER COMMUNICATING WITH THE PATIENT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20887841 ↗
• MalfunctionDec 9, 2024Misconnection; Misconnection

  IT WAS REPORTED ON (B)(6) AT 13:05, DR. (B)(6) A CLOSED DRAINAGE OF THE LEFT THORACIC CAVITY AND USED A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER STATLOCK CATHETER FIXATOR 2 TIMES TO FIX IT. ON (B)(6) 2024, 17:50, P-SHIFT BEDSIDE HANDOVER, CHECKING THE PATIENT'S LEFT THORACIC DRAINAGE TUBE, AND FOUND THAT THE PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER STATLOCK CATHETER FIXATOR WAS BROKEN, IMMEDIATELY INFORM THE NURSE MANAGER, BEDSIDE DOCTOR, AND GIVE THE DRESSING TAPE PROPERLY FIXED, AGAIN CHECK THE DRAINAGE TUBE IS SMOOTH, NO TWISTING, PUNCTURE STERILE DRESSING INTACT, NO OOZING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878624 ↗
• MalfunctionAug 28, 2024Misconnection; Misconnection

  IT WAS REPORTED WHEN MAINTAINING THE PICC, FOUND THAT THE BUCKLE COULD NOT BE FASTENED AND WOULD AUTOMATICALLY POP UP, UNABLE TO FIX IT. REPLACED WITH A NEW PRODUCT TO OPERATE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089173 ↗
• MalfunctionAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SLUG BUCKLE OPENS AND BUCKLES SEPARATES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047643 ↗
• MalfunctionJul 25, 2024Misconnection; Misconnection

  IT WAS REPORTED ON JUNE 21, 2024, WHEN THE CLINICIAN USED A PERIPHERAL CANNULATED CENTRAL VENOUS CATHETER (CELESTIAL BUCKLE) FOR CATHETER MAINTENANCE FOR THE PATIENT, IT WAS FOUND THAT THE BUTTON COULD NOT BE OPENED AND COULD NOT BE BUCKLED, AND IT WAS IMMEDIATELY REPLACED, AND NO ADVERSE EVENTS WERE CAUSED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826676 ↗
• MalfunctionFeb 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT CLAMP LOOSENS FROM BANDAGE. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18728145 ↗
• MalfunctionFeb 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT CLAMP LOOSENS FROM BANDAGE. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18728143 ↗
• MalfunctionFeb 16, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED, "THE PATIENT NEEDS TO BE IMPLANTED WITH AN INTRAVENOUS CATHETER FOR ADMINISTRATION, CHECK THAT THE PACKAGING OF THE PERIPHERAL CANNULATION CENTRAL VENOUS CATHETER IS COMPLETE, AND WITHIN THE VALIDITY PERIOD, AFTER OPENING THE PACKAGE, IT IS FOUND THAT THERE IS A HAIR-LIKE FOREIGN BODY IN THE PACKAGE, REPLACE THE NEW CATHETER, AND COMPLETE THE OPERATION." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720877 ↗
• MalfunctionDec 12, 2023Misconnection; Material Twisted/Bent; Misconnection; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2023, AT 9:00, WE CHANGED THE PICC DRESSING FOR PATIENT AND PERFORMED CATHETER FIXATION, AND FOUND THAT THE FIXATOR BUTTON WAS NOT SECURELY FASTENED. POOR FIXATION OF THE TUBE IS LIKELY TO CAUSE THE TUBE TO SLIP OUT, RESULTING IN ACCIDENTAL EXTUBATION. AFTER THE DISCOVERY OF THE IMMEDIATE REPLACEMENT OF MATERIALS, AND NOTIFY THE HEAD NURSE, THE PATIENT AFTER FOLLOW-UP OBSERVATION, NO OBVIOUS DISCOMFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314282 ↗
• MalfunctionSep 30, 2020Misconnection; Misconnection

  ON (B)(6) 2020, THE 521-111 BED PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PICC CATHETER WAS MAINTAINED, AND WHEN THE PERIPHERAL INTUBATION CENTRAL VENOUS CATHETER WAS REPLACED, IT WAS FOUND THAT THE BUCKLE WAS NOT TIGHTLY CLOSED, AND IT WAS REPLACED IMMEDIATELY WITHOUT ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10610270 ↗
• MalfunctionAug 26, 2020Misconnection; Misconnection

  IT WAS REPORTED THAT WHEN THE CATHETER WAS MAINTAINED THE FOLLOWING DAY AFTER PLACEMENT, THE LATCH OF THE STATLOCK WAS FOUND BROKEN. IT MADE THE CATHETER UNABLE TO BE USED PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457577 ↗
• MalfunctionMar 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE ADHESIVE PORTION OF DEVICE DETACHED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793470 ↗