Statlock IVRecalls & reported problems across all models

We found 9 models of Statlock IV by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Apr 27, 2017 and Jun 3, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (28 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 IV problems

Statlock IV models

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

• Statlock IV IV0564

  Set, administration, intravascular
  19 reports
• Statlock IV IV0566

  Set, administration, intravascular
  16 reports
• Statlock IV IV0225

  Set, administration, intravascular
  14 reports
• Statlock IV IV0572

  Set, administration, intravascular
  6 reports
• Statlock IV IV0221

  Set, administration, intravascular
  4 reports
• Statlock IV IV0563

  Set, administration, intravascular
  3 reports
• Statlock IV IV0521CE

  Set, administration, intravascular
  1 report
• Statlock IV IV0525

  Set, administration, intravascular
  1 report
• Statlock IV IV0563P

  Set, administration, intravascular
  1 report

Recent Statlock IV adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT THE TUBING DISCONNECTED FROM THE IV HUB. THE WHITE TUBING BECAME DETACHED, CAUSING BLOOD AND IV FLUIDS TO SPILL OVER THE PATIENT AND REPORTEDLY ONTO THE NURSE AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382747 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH THAT BD STATLOCK CATHETER STABILIZATION DEVICE IV SELECT - TUBING BURST OPEN WHILE BEING FLUSHED. THE DEFECT OCCURRED IN THE BODY OF THE TUBING, NOT AT ANY CONNECTION POINTS. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24961284 ↗
• MalfunctionMar 3, 2026

  BD STATLOCK CATHETER STABILIZATION DEVICE IV SELECT - TUBING BURST OPEN WHILE BEING FLUSHED. THE DEFECT OCCURRED IN THE BODY OF THE TUBING--NOT AT ANY CONNECTION POINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501010 ↗
• MalfunctionFeb 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER DISCONNECTION OF THE LUER LOCK FROM THE EXTENSION TUBING FROM STATLOCK PRODUCT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634694 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED BY THE CUSTOMER IV TUBING 2 PORT EXTENDING FROM IV CATH IS SPECIFICALLY MALFUNCTIONING WHEN AN IV TUBING IS PULLED ON OR DISLODGED BY THE PATIENT. THIS PATIENT HAD REMOVED ALL OF HIS IVS THIS NIGHT AND EACH ONE HAD MALFUNCTIONED/ BROKE IN THE SAME LOCATION WHICH WAS THE TUBING CONNECTED TO THE END PIECE THAT CONNECTED DIRECTLY TO THE IV CATH THAT WAS INSERTED INTO THE PATIENT. EVENT OCCURRED IN PATIENT ROOM, BUT NO HARM WAS EVIDENT. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 04 JANUARY 2024: IT WAS REPORTED BY THE CUSTOMER "PRODUCT DISCONNECTED AT HUB AND BLEEDING WAS IDENTIFIED IMMEDIATELY, WITHOUT HARM. EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. DEVICE WAS DISCARDED." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491293 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED BY THE CUSTOMER IV TUBING 2 PORT EXTENDING FROM IV CATH IS SPECIFICALLY MALFUNCTIONING WHEN AN IV TUBING IS PULLED ON OR DISLODGED BY THE PATIENT. THIS PATIENT HAD REMOVED ALL OF HIS IVS THIS NIGHT AND EACH ONE HAD MALFUNCTIONED/ BROKE IN THE SAME LOCATION WHICH WAS THE TUBING CONNECTED TO THE END PIECE THAT CONNECTED DIRECTLY TO THE IV CATH THAT WAS INSERTED INTO THE PATIENT. EVENT OCCURRED IN PATIENT ROOM, BUT NO HARM WAS EVIDENT. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED (B)(6). 2024: IT WAS REPORTED BY THE CUSTOMER "PRODUCT DISCONNECTED AT HUB AND BLEEDING WAS IDENTIFIED IMMEDIATELY, WITHOUT HARM. EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. DEVICE WAS DISCARDED." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491283 ↗
• MalfunctionJan 10, 2024Break; Break

  IT WAS REPORTED THAT, "THE IV EXTENSION TUBING BROKE AT THE HUB BETWEEN THE IV CATHETER AND THE INFUSION PORTS. PATIENT WAS RECEIVING HEPARIN SO THERE WAS A SCANT ABOUT OF BLOOD LOSS FROM THE DISCONNECT THANKFULLY IT WAS CAUGHT FAST ENOUGH BY RN. BODILY OR PSYCHOLOGICAL INJURY RESULTING IN MINIMAL SYMPTOMS, LOSS OF FUNCTION, INJURY LIMITED TO ADDITIONAL TREATMENT, MONITORING, AND/OR INCREASED LENGTH OF STAY." ADDITIONAL INFORMATION RECEIVED: COMPLETELY BROKEN INTO 2 PIECES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18490348 ↗
• MalfunctionJun 13, 2023Break; Break

  IT WAS REPORTED, "TUBING IS COMING AWAY FROM HUB/SNAPPING OFF. INCIDENT HAPPENED ON WARD AND ATTACHED TO PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17122284 ↗
• MalfunctionJun 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "PATIENT WAS INACTIVE / NOT MOBILE AND EXTENSION SET HAD BECOME FRACTURED. THIS CAUSED BLOOD TO LEAK FROM THE CATHETER POSING DANGER TO PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086743 ↗
• MalfunctionNov 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER VIA MEDWATCH "FOUND THAT THE CLAMP ON THE EXTENSION SET HAD MADE A CUT IN THE EXTENSION SET TUBING WHICH CAUSED THE IV TO BACK UP AND LEAK. RN REPLACED THE EXTENSION SET. THIS WAS A STATLOCK CATHETER STABILIZATION. WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. NO HARM REPORTED. BLOOD SPILL OCCURRED AND THE RN HAD TO REPLACE THE FAULTY EXTENSION TUBING. WHAT THEY¿RE BEING TREATED FOR: SURGERY FOR HYSTERECTOMY. *DOES THE PATIENT HAVE AN INFECTIOUS DISEASE? NO.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15763842 ↗
• MalfunctionNov 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY MEDWATCH "IV TUBING SEPARATED FROM LUER LOCK HUB THAT WAS ATTACHED TO A PATIENT'S IV CATHETER. CLEAN EDGES, TUBING HAD NOT BEEN CUT. PATIENT'S IV CLOTTED, SO NO BACKFLOW OF BLOOD OR BLOOD LOSS FROM PATIENT." 10/24/22 ADDITIONAL INFORMATION PROVIDED: EVENT INFORMATION ¿ DATE OF OCCURRENCE: (B)(6) 2022 ¿ PLACEMENT DATE: (B)(6) 2022 ¿ EXPLANT DATE: 1(B)(6) 2022 PATIENT INFORMATION (IF AVAILABLE) ¿ WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. NONE REPORTED ¿ AGE: 64 ¿ SEX: MALE ¿ WEIGHT: 210LB/ 95.3KG ¿ WHAT THEY¿RE BEING TREATED FOR: SURGERY/ARTHOPLASTY OF KNEE ¿ OTHER RELEVANT HISTORY: NONE APPLICABLE ¿ CONCOMITANT THERAPY: INTERMITTENT SALINE FLUSH OF LINE AS PER MD ORDER; NO CONTINUOUS INFUSIONS OR OTHER INTERMITTENT INFUSIONS AT TIME OF DISCOVERY ¿ *DOES THE PATIENT HAVE AN INFECTIOUS DISEASE?: NONE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712340 ↗
• MalfunctionSep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE IV STAT LOCK MALFUNCTIONING WHERE THE TUBING SPLIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505349 ↗
• MalfunctionSep 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE IV STAT LOCK MALFUNCTIONED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499510 ↗
• MalfunctionSep 28, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED " FLUID LEAKED FROM A CRACK IN THE HUB."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499396 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "SMALL CRACK/HOLE IN STATLOCK IV EXTENSION SET CAUSING PATIENT'S BLOOD TO SPRAY OUT OF SIDE OF TUBING CAUSING PATIENT BLOOD LOSS, DISTRESS AND STAINING PATIENT'S CLOTHING WITH BLOOD."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14317716 ↗

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