Peripheral Catheter Insertion Kit ST020100Recalls & reported problems
Bard Access Systems, Inc. · Sldgr IDC, 20gx10cm, Basic · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741139222), received between Jul 22, 2025 and Jul 22, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Material Deformation; Material Deformation
IT WAS REPORTED WHEN ATTEMPTING TO ADVANCE THE CATHETER AND INNER SHEATH OVER THE WIRE WE MEET RESISTANCE AT THE TIP OF THE CATHETER SUCH THAT THE CATHETER IS UNABLE TO ADVANCE FURTHER/THE WIRE CANNOT PASS THE RESISTANCE. UPON INSPECTION THERE APPEARS TO BE A DEFECT IN THE END OF THE INNER CATHETER. THIS HAS OCCURRED ON THREE SUCH CATHETERS FROM THE SAME LOT. THERE WAS NO HARM TO PATIENT. THIS REPORT ADDRESSES ALL THREE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22572584 ↗
Other Midline catheter devices
- Midline Catheter Kit P4154108DBard Access Systems, Inc. · Midline catheter1 recall1 death126 reports
- ARROW IPN921959Teleflex Incorporated · Midline catheter2 recalls0 reports
- Midline Catheter Kit S4153108BDPBard Access Systems, Inc. · Midline catheter1 recall36 reports
- Midline Catheter Kit S4153108DBard Access Systems, Inc. · Midline catheter1 recall32 reports
- Midline Catheter Kit S4153108DGPBard Access Systems, Inc. · Midline catheter1 recall15 reports
- Midline Catheter Kit S4254108BDPBard Access Systems, Inc. · Midline catheter1 recall11 reports
- Midline Catheter Kit P4154108Bard Access Systems, Inc. · Midline catheter1 recall10 reports
- ARROW IPN037698Teleflex Incorporated · Midline catheter1 recall9 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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