Statlock IV Select Start KitRecalls & reported problems across all models

We found 5 models of Statlock IV Select Start Kit by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2018 and May 6, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Disconnection” (6 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 Select Start Kit problems

Statlock IV Select Start Kit models

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

• Statlock IV Select Start Kit IVK0135

  Set, administration, intravascular
  10 reports
• Statlock IV Select Start Kit IVK0177

  Set, administration, intravascular
  6 reports
• Statlock IV Select Start Kit IVK0124

  Set, administration, intravascular
  3 reports
• Statlock IV Select Start Kit IVK0119

  Set, administration, intravascular
  1 report
• Statlock IV Select Start Kit IVK0136

  Set, administration, intravascular
  1 report

Recent Statlock IV Select Start Kit adverse event reports

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

• MalfunctionMay 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THE HUB ON THE EXTENSION TO THE CATHETER IS COMING UNDONE PRETTY EASILY. IT¿S DISCONNECTING FROM THE IV FLUID, AND IN CT THE PRESSURE IS ACTUALLY BLOWING THE HUB OFF THE CONNECTOR AND SPRAYING CONTRAST EVERYWHERE. THEY MENTIONED THIS HAS BEEN HAPPENING FOR THE PAST FEW MONTHS. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107971 ↗
• MalfunctionMay 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED IV INITIATED ON (B)(6) 2020, ON (B)(6) 2020 THE IV J-LOOP TUBING BROKE FROM HUB. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10096321 ↗
• MalfunctionMay 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "YESTERDAY AFTERNOON I HAD A PATIENT'S J LOOP ATTACHED TO THE IV CATHETER COME OUT FROM THE PLASTIC ATTACHMENT. IT WAS ATTACHED AT THE SITE WHERE THE STAT LOCK IS SO THE PATIENT COULDN'T HAVE INADVERTENTLY PULLED IT OUT".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10050006 ↗
• MalfunctionMar 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STATLOCK FELL OFF OF FOUR DIFFERENT PATIENTS, CAUSING BLOOD TO LEAK. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FOURTH OF FOUR DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880375 ↗
• MalfunctionMar 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STATLOCK FELL OFF OF FOUR DIFFERENT PATIENTS, CAUSING BLOOD TO LEAK. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE THIRD OF FOUR DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880374 ↗
• MalfunctionMar 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STATLOCK FELL OFF OF FOUR DIFFERENT PATIENTS, CAUSING BLOOD TO LEAK. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND OF FOUR DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880369 ↗
• MalfunctionMar 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STATLOCK FELL OFF OF FOUR DIFFERENT PATIENTS, CAUSING BLOOD TO LEAK. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST OF FOUR DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9880368 ↗
• MalfunctionNov 7, 2018Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FACILITY HAS HAD 3 CRACKED BARROWS ON THE STATLOCK WHICH CAUSED A SERIOUS LEAK ON ONE OF THE PATIENTS AND ISSUES ON THE OTHERS. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8047665 ↗
• MalfunctionNov 7, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT THE FACILITY HAS HAD 3 CRACKED BARROWS ON THE STATLOCK WHICH CAUSED A SERIOUS LEAK ON ONE OF THE PATIENTS AND ISSUES ON THE OTHERS. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8047663 ↗
• MalfunctionNov 7, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT THE FACILITY HAS HAD 3 CRACKED BARROWS ON THE STATLOCK WHICH CAUSED A SERIOUS LEAK ON ONE OF THE PATIENTS AND ISSUES ON THE OTHERS. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8047639 ↗
• MalfunctionOct 4, 2018Crack; Leak/Splash

  PER MEDWATCH: NUCLEAR MEDICINE TECH WAS INJECTING NUCLEAR ISOTOPE AND THE IV EXTENSION SET LEAKED. UPON REVIEW OF THE EXTENSION SET, A CRACK WAS NOTED AT THE CONNECTION SITE. ON 09/19/2018 ADDITIONAL INFORMATION STATED, "THE CRACKED HUB WAS FOUND DURING PLACEMENT AND USE, THE DEVICE LEAKED WHEN INJECTED. NO HARM TO THE PATIENT".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7936755 ↗
• MalfunctionAug 17, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE IV WAS SUCCESSFULLY HAND FLUSHED WITH SALINE AND WITH POWER INJECTOR FOR TESTING, BUT A SMALL AMOUNT OF CONTRAST INFILTRATED INTO PATIENT'S ARM DURING INJECTION. A NEW DEVICE HAD TO BE PLACED BY THE CT TECH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7792557 ↗
• MalfunctionAug 17, 2018Disconnection

  IT WAS REPORTED THAT THE IV WAS HAND FLUSHED WITH SALINE AND WITH THE POWER INJECTOR FOR TESTING, WHICH WORKED WELL, BUT BECAME DISCONNECTED DURING THE INJECTION OF CONTRAST. A NEW DEVICE HAD TO BE PLACED BY THE CT TECH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792553 ↗
• MalfunctionAug 17, 2018Disconnection

  IT WAS REPORTED THAT THE IV WAS TEST FLUSHED WITH SALINE BY HAND WITH NO ISSUES, BUT THE IV DISCONNECTED DURING THE POWER INJECTOR FLUSH. THE CT TECH TOOK OFF THE STATLOCK AND EXTENSION TUBING AND PLACED A NEW CONNECTOR ONTO THE IV. THE TECH THEN FLUSHED BY HAND AND WITH THE POWER INJECTOR WITH NO ISSUES; THE IV WORKED FINE AND THE SCANS WERE COMPLETED. IT WAS NOTED BY COMPLAINANT THAT "THIS ISSUE CAUSED A DELAY IN PATIENT CARE. THERE WAS A POTENTIAL RISK FOR IV INFILTRATION, REPEAT SCANS OR INSUFFICIENT STUDIES. BUT THIS CASE JUST CAUSED A DELAY IN CARE." NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792536 ↗
• MalfunctionAug 17, 2018Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE IV WAS TEST FLUSHED WITH SALINE BY HAND AND THEN AGAIN WITH THE POWER INJECTOR WITH NO ISSUES. DURING THE TEST BOLUS, THE IV BECAME DISCONNECTED AND LEAKED ALL OVER THE PATIENT AND THE TABLE. THE CT TECH HAD TO "TAKE ALL OF THE TAPE, THE CONNECTOR AND THE BLUE LOCKING PIECE OFF OF THE IV HUB, AND ATTACH THEIR OWN CONNECTOR TO THE IV." THEN THE CT TECH CLEANED UP THE PATIENT AND THE TABLE AND THE SCAN WAS COMPLETED. THIS CAUSED A DELAY IN PATIENT CARE AND HELD UP OUR SCAN ROOM LONGER THAN USUAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792521 ↗

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