ARROW IPN047912Recalls & reported problems
Teleflex Incorporated · FlexTip Plus(R) Epidural Catheter · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801902124866), received between Jun 15, 2022 and Aug 3, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Most reported problems
Device problems
- Difficult to Remove1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2022Material Separation; Material Separation
THE BREAK IS NEAR THE OPPOSITE END OF WHERE THE PATIENT WAS AND THE PART THAT WAS IN THE PATIENT IS INTACT. NOTHING WAS LEFT IN THE PATIENT; ALL PARTS WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15159152 ↗MalfunctionJun 15, 2022Difficult to Remove; Difficult to Remove
I WAS REMOVING THE EPIDURAL CATHETER FROM THE PATIENTS BACK AND THE TUBING SNAPPED IN HALF AND WAS FRAYED. I WAS ABLE TO GET THE REMAINING END OF THE CATHETER OUT OF THE PATIENT AND THE TIP WAS INTACT. ALL PIECES OF THE EQUIPMENT WERE ACCOUNTED FOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14696599 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.