HUDSON RCI IPN048992Recalls & reported problems
Teleflex Incorporated · SHER-I-SWIV/FO · Class 1
All models of HUDSON RCI (152)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704617378), received between Oct 21, 2022 and Oct 21, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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 18, 2026.
Most reported problems
Device problems
- Fracture4
- Loose or Intermittent Connection4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2022Fracture; Loose or Intermittent Connection; Fracture; Loose or Intermittent Connection
COMPLAINT REPORTS THAT: "BLUE PLASTIC TUBE CONNECTED TO THE MAIN BODY IS LOOSE. NOT CONNECTED PROPERLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15649767 ↗MalfunctionOct 21, 2022Fracture; Loose or Intermittent Connection; Fracture; Loose or Intermittent Connection
COMPLAINT REPORTS THAT: "BLUE PLASTIC TUBE CONNECTED TO THE MAIN BODY IS LOOSE. NOT CONNECTED PROPERLY." THE ISSUE WAS DETECTED PRIOR TO USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15649765 ↗MalfunctionOct 21, 2022Fracture; Loose or Intermittent Connection; Fracture; Loose or Intermittent Connection
COMPLAINT REPORTS THAT: "BLUE PLASTIC TUBE CONNECTED TO THE MAIN BODY IS LOOSE. NOT CONNECTED PROPERLY." THE ISSUE WAS DETECTED PRIOR TO USE ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15649755 ↗MalfunctionOct 21, 2022Fracture; Loose or Intermittent Connection; Fracture; Loose or Intermittent Connection
COMPLAINT REPORTS THAT: "BLUE PLASTIC TUBE CONNECTED TO THE MAIN BODY IS LOOSE. NOT CONNECTED PROPERLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15649749 ↗
Other STYLET, TRACHEAL TUBE devices
- Shiley 85864Covidien LP · STYLET, TRACHEAL TUBE15 reports
- Shiley 85863Covidien LP · STYLET, TRACHEAL TUBE13 reports
- GlideRite® Single-Use Stylet – SmallVerathon Medical (Canada) ULC · Stylet, Tracheal Tube7 reports
- HUDSON RCI IPN044847Teleflex Incorporated · STYLET, TRACHEAL TUBE4 reports
- Shiley 85865Covidien LP · STYLET, TRACHEAL TUBE3 reports
- Vital Signs™ S5000NAirlife · STYLET, TRACHEAL TUBE2 reports
- Mallinckrodt 85864Covidien LP · STYLET, TRACHEAL TUBE2 reports
- Mallinckrodt 85865Covidien LP · STYLET, TRACHEAL TUBE1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page