ARROW IPN040129Recalls & reported problems
Teleflex Incorporated · Epidural Catheterization Kit with FlexTip Plus(R) Catheter · 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 10801902126358), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K103658); they may or may not involve this specific model.
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 Separation1
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.
MalfunctionMar 19, 2024Material Separation; Material Separation
IT WAS REPORTED THAT: UPON USING THE CATHETER, THE CATHETER ACTUALLY SEPARATED, AND THE ENDS APPEARED FRAYED. THE PATIENT RECEIVED P ROPHYLACTIC ANTIBIOTICS AND WAS REPORTED AS GOOD AFTER THE ISSUE. THERE WAS NO OTHER REPORTED PATIENT HARM OR CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18933417 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103658. One submission often covers many models, so check the product and lot details in each record.
- Z-2364-2026 · Apr 21, 2026 · Open, ClassifiedDescription/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;
- Z-1179-2020 · Jan 15, 2020 · TerminatedFlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
- Z-1962-2018 · Apr 11, 2018 · TerminatedSnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
- Z-2462-2015 · Jul 30, 2015 · TerminatedPICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
Other Anesthesia conduction kit devices
- BD Luer-Lok, BD Glaspak 405671Becton, Dickinson And Company · Anesthesia conduction kit1 recall68 reports
- ARROW IPN922678Teleflex Incorporated · Anesthesia conduction kit2 recalls0 reports
- BD Luer-Lok, BD Glaspak 405672Becton, Dickinson And Company · Anesthesia conduction kit1 recall27 reports
- BD Luer-Lok, BD Glaspak 405673Becton, Dickinson And Company · Anesthesia conduction kit1 recall10 reports
- BD Luer-Lok, BD Glaspak 405637Becton, Dickinson And Company · Anesthesia conduction kit1 recall7 reports
- BD Luer-Lok, BD Glaspak 405707Becton, Dickinson And Company · Anesthesia conduction kit1 recall4 reports
- BD Luer-Lok, BD Glaspak 405609Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405735Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 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.
How reports and recalls are matched · Editorial policy · Report an error on this page