Curaplex 1612-84130Recalls & reported problems
Bound Tree Medical, LLC · IV Catheter, ClearSafe, 18 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817617022369), received between May 22, 2025 and May 7, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Blocked Connection” (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. 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
- Blocked Connection1
- Damaged Thread1
- Material Fragmentation1
- Material Separation1
- Material Split, Cut or Torn1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Material Fragmentation; Material Separation; Blocked Connection; Damaged Thread
THE USER STARTED THE IV AND WHEN THE NEEDLE WAS RETRACTED IT APPEARED TO NOT GO IN ALL THE WAY. UPON FURTHER REVIEW WHEN THE USER ATTEMPTED TO CONNECT AN EXTENSION SET IT WAS NOTICED THAT THERE WAS A PIECE OF PLASTIC INSIDE THE HUB OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117356 ↗InjuryMay 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
WHEN I REMOVED THE NEEDLE PORTION FROM THE HUB, THE HUB WAS NO LONGER ATTACHED TO THE CATHETER. THE CATHETER WAS NOT ABLE TO BE SEEN PROTRUDING OUT OF THE SKIN TO BE REMOVED. THE CATHETER WAS COMPLETELY INSIDE THE VEIN.
Patient problems: Foreign Body In Patient
MAUDE report 22072461 ↗
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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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