Epimed 202-1936Recalls & reported problems
Epimed International, Inc · Spirol® Close End 19g x 36" Epidural 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 00818788021175), received between Jun 26, 2018 and Jun 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (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
- Disconnection1
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.
MalfunctionJun 26, 2018Disconnection
CATHETER BECAME DISCONNECTED FROM THE BLUE CONNECTOR SITE.
Patient problems: No Information
MAUDE report 7639357 ↗
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-2312-2021 · Dec 28, 2017 · CompletedNEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
- Z-2313-2021 · Dec 28, 2017 · CompletedNEO-KATH(TM) Caudal Set, REF 201-2430, 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.