Epimed 107-1314Recalls & reported problems
Epimed International, Inc · RX-2™ Coudé® Epidural Needle 14g TW x 4.0" · Class 2
- 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 00818788020338), received between Apr 3, 2019 and Apr 3, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 other recall cover devices cleared under the same FDA submission (K053318); 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
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED TO NEVRO THAT THE INSERTION NEEDLE DETACHED FROM THE HUB DURING THE TRIAL PROCEDURE. THE PHYSICIAN WAS ABLE TO REMOVE THE INSERTION NEEDLE WITHOUT INCIDENT AND THERE WERE NO INJURIES TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER REPORTS OF COMPLICATIONS AND THE PATIENT HAD A SUCCESSFUL TRIAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8480914 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K053318. One submission often covers many models, so check the product and lot details in each record.
- Z-0087-2018 · Jul 24, 2017 · TerminatedRX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices
- ARROW IPN922632Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 recalls0 reports
- ARROW IPN922603Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922605Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- 22G 1 1/2IN Regional Block Needle 408348Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922631Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922604Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- BD QUINCKE Spinal Needles 405180Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)23 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.