Statlock IV IV0564Recalls & reported problems
Bard Access Systems, Inc. · StatLock IV Select macro 6in SmartSite Y and valve 25 box · Class 2
All models of Statlock IV (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741082047), received between Apr 26, 2018 and Jun 3, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak8
- Leak/Splash4
- Crack3
- Detachment of Device or Device Component3
Patient problems
- No Consequences Or Impact To Patient8
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient4
- Hemorrhage/Blood Loss/Bleeding1
- No Information1
Recent adverse event reports
The 19 most recent of 19 reports, 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 ↗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 ↗MalfunctionApr 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE NURSE EXPERIENCED A LEAKING IV CATHETER TUBING IN THE MIDDLE OF CARING FOR A CRITICALLY ILL ADULT. IT IS STATED THERE APPEARED TO BE A LEAK FROM A HOLE IN THE TUBING IN THE LOCATION WHERE THE CLAMP HAD BEEN ON THE TUBING. THIS REPORT ADDRESSES THE FOURTH OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9945256 ↗MalfunctionApr 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE NURSE EXPERIENCED A LEAKING IV CATHETER TUBING IN THE MIDDLE OF CARING FOR A CRITICALLY ILL ADULT. IT IS STATED THERE APPEARED TO BE A LEAK FROM A HOLE IN THE TUBING IN THE LOCATION WHERE THE CLAMP HAD BEEN ON THE TUBING. THIS REPORT ADDRESSES THE SECOND OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9945251 ↗MalfunctionApr 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE NURSE EXPERIENCED A LEAKING IV CATHETER TUBING IN THE MIDDLE OF CARING FOR A CRITICALLY ILL ADULT. IT IS STATED THERE APPEARED TO BE A LEAK FROM A HOLE IN THE TUBING IN THE LOCATION WHERE THE CLAMP HAD BEEN ON THE TUBING. THIS REPORT ADDRESSES THE THIRD OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9945247 ↗MalfunctionApr 2, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE NURSE EXPERIENCED A LEAKING IV CATHETER TUBING IN THE MIDDLE OF CARING FOR A CRITICALLY ILL ADULT. IT IS STATED THERE APPEARED TO BE A LEAK FROM A HOLE IN THE TUBING IN THE LOCATION WHERE THE CLAMP HAD BEEN ON THE TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9916786 ↗MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED DURING SHIFT REPORT ONCOMING RN NOTICED THAT IV CONNECTION PORT WAS BROKEN OFF OF PATIENTS Y TUBING. PER OFF-GOING RN IT HAD BEEN THAT WAY AT THE START OF HER SHIFT. PER CHARTING THE LINE WAS FLUSHED AT 0059 BUT NO IV MEDICATIONS WERE GIVEN THAT SHIFT. IV WAS REMOVED AND INFECTION PREVENTION WAS NOTIFIED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9856812 ↗MalfunctionMar 18, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXPERIENCED RN PLACED IV, DREW BLOOD FOR LABS, AND WHEN SHE WENT TO FLUSH THE INT, BLOOD SPRAYED ALL OVER HER FROM WHAT SHE DESCRIBED AS "A TINY HOLE".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9847382 ↗MalfunctionSep 13, 2019Crack; Crack
IT WAS REPORTED THAT THE IV TUBING CRACKED AT THE HUB. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9035833 ↗MalfunctionSep 12, 2019Crack; Crack
IT WAS REPORTED THAT THE IV TUBING CRACKED AT THE HUB ON TWO DEVICES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST CRACKED DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9010532 ↗MalfunctionSep 12, 2019Crack
IT WAS REPORTED THAT THE IV TUBING CRACKED AT THE HUB ON TWO DEVICES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND CRACKED DEVICE.
Patient problems: No Information
MAUDE report 9010528 ↗MalfunctionApr 26, 2018Leak/Splash
IT WAS REPORTED BY THE FACILITY THAT THE DEVICE WAS FOUND TO BE LEAKING AROUND THE LUER LOCK. THIS REPORT ADDRESS THE THIRD OF FOUR DEVICES FOUND TO BE LEAKING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7466875 ↗MalfunctionApr 26, 2018Leak/Splash
IT WAS REPORTED BY THE FACILITY THAT THE DEVICE WAS FOUND TO BE LEAKING AROUND THE LUER LOCK. THIS REPORT ADDRESS THE FOURTH OF FOUR DEVICES FOUND TO BE LEAKING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7466870 ↗MalfunctionApr 26, 2018Leak/Splash
IT WAS REPORTED BY THE FACILITY THAT THE DEVICE WAS FOUND TO BE LEAKING AROUND THE LUER LOCK. THIS REPORT ADDRESS THE SECOND OF FOUR DEVICES FOUND TO BE LEAKING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7466867 ↗MalfunctionApr 26, 2018Leak/Splash
IT WAS REPORTED BY THE FACILITY THAT THE DEVICE WAS FOUND TO BE LEAKING AROUND THE LUER LOCK. THIS REPORT ADDRESS THE FIRST OF FOUR DEVICES FOUND TO BE LEAKING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7466863 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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