ARROW IPN919607Recalls & reported problems
Teleflex Incorporated · TheraCath(R) Epidural Catheterization Kit · Class 2
All models of ARROW (1494)
Data updated Oct 16, 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 14026704736765), received between Feb 23, 2023 and Feb 23, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
10 other recalls cover devices cleared under the same FDA submission (K801912); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
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.
MalfunctionFeb 23, 2023Material Separation; Material Separation
REPORTED ISSUE: THE EPIDURAL BROKE DURING PATIENT USE AND CONSEQUENTLY LEAKED; DETECTED VISUALLY. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16432193 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K801912. 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-2803-2020 · Jul 6, 2020 · TerminatedArrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
- Z-1175-2020 · Jan 15, 2020 · TerminatedTheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
- Z-1248-2020 · Dec 20, 2019 · TerminatedArrow EPIDURAL CATHETERIZATION KIT AM-05500
- Z-1247-2020 · Dec 20, 2019 · TerminatedArrow EPIDURAL CATHETERIZATION KIT JH-05500
- Z-1246-2020 · Dec 20, 2019 · TerminatedArrow EPIDURAL CATHETERIZATION KIT YC-02220
- Z-1249-2020 · Dec 20, 2019 · TerminatedArrow EPIDURAL CATHETERIZATION KIT CK-02220
- Z-1251-2020 · Dec 20, 2019 · TerminatedArrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
- Z-1245-2020 · Dec 20, 2019 · TerminatedArrow EPIDURAL CATHETERIZATION KIT AK-05000
- Z-2012-2018 · Apr 11, 2018 · TerminatedTheraCath(R) Epidural Catheter; Product Code: EC-05000
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 405735Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405609Becton, 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 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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