Epimed 194-2036Recalls & reported problems
Epimed International, Inc · Spirol® 20g x 36" Short Epidural Set · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818788021649), received between Jun 26, 2018 and Sep 14, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Handling Problem1
- Device Issue1
- Disconnection1
Patient problems
- Foreign Body In Patient1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Detachment of Device or Device Component
MD using touhy needle during surgery prolene suture was threaded through the touhy needle and introduced into abdomen, While needle was inside patient and manipulated by the surgeon the needle snapped off at the base of the touhy. The surgeon retrieved if from the abdomen.
Patient problems: Foreign Body In Patient
MAUDE report 50752379 ↗MalfunctionJun 26, 2018Disconnection
CATHETER BECAME DISCONNECTED AT THE BLUE CONNECTOR SITE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7639364 ↗MalfunctionJun 26, 2018Device Issue; Device Handling Problem; Device Issue; Device Handling Problem
REMOVED AS PER PROTOCOL, HOWEVER HAD BEEN KINKED AND LEAKING.
Patient problems: No Information
MAUDE report 7639362 ↗
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 IPN925052Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN925020Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN922619Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN924975Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 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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