Epimed 193-2036Recalls & reported problems
Epimed International, Inc · Spirol® Close End 20g x 36" Short Crawford Set, Styletted · 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 00818788022264), received between Aug 24, 2018 and Aug 24, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K981329); 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
- Device Handling Problem1
- Mechanical Problem1
- Patient Device Interaction Problem1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2018Mechanical Problem; Device Handling Problem; Patient Device Interaction Problem; Mechanical Problem; Device Handling Problem; Patient Device Interaction Problem
THE TIP OF THE CAUDAL CATHETER WAS RETAINED IN THE PATIENT UPON CATHETER REMOVAL. ABOUT 1.5 CM OF THE CATHETER TIP REMAINS IN THE CAUDAL SPACE.
Patient problems: No Information
MAUDE report 7814105 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K981329. One submission often covers many models, so check the product and lot details in each record.
- Z-2313-2021 · Dec 28, 2017 · CompletedNEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
- Z-2312-2021 · Dec 28, 2017 · CompletedNEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Other CATHETER, CONDUCTION, ANESTHETIC devices
- ARROW IPN925037Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC7 recalls0 reports
- ARROW IPN924999Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC3 recalls0 reports
- ARROW IPN924964Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls1 report
- ARROW IPN927743Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN922619Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN924975Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN925052Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN925020Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.