ARROW IPN046379Recalls & reported problems
Teleflex Incorporated · FlexTip Plus(R) Epidural 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 40801902128360), received between Feb 23, 2021 and Feb 23, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionFeb 23, 2021Break; Break
EPIDURAL CATHETER WAS REMOVED FROM A PATIENT POST AN UNEVENTFUL DELIVERY. PROVIDER ATTEMPTED TO REMOVE THE EPIDURAL CATHETER FROM THE PATIENT'S BACK 3-4 TIMES AND WITH POSITION CHANGES. AFTER THE THIRD OR FOURTH ATTEMPT THE CATHETER BROKE OFF LEAVING APPROXIMATELY 10 CM OF THE CATHETER INSITU. APPROXIMATE LENGTH OF CATHETER REMAINING IN PATIENT'S BACK WAS DETERMINED USING U/S AND BASED ON ASSESSMENT OF THE MARKINGS ON THE CATHETER THAT WAS REMOVED. AFTER CONSULTATION WITH VASCULAR AND ORTHOPEDIC SURGEONS IT WAS DECIDED THAT CATHETER WOULD REMAIN IN PLACE AND SURGICAL REMOVAL WOULD NOT BE REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11365813 ↗
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.
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