Epimed 155-2342Recalls & reported problems
Epimed International, Inc · Brevi-XL™/2 19g x 14" · Class 2
Data updated Oct 13, 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 00818788021069), received between Aug 31, 2018 and Aug 31, 2018 — classified as 1 malfunction.
1 other recall cover devices cleared under the same FDA submission (K954584); 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
- Appropriate Device Problem Term/Code Not Available1
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 31, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON AUGUST 8, 2018, EPIMED RECEIVED NOTIFICATION OF AN INCIDENT INVOLVING A SHEARED 18G BREVI-XL/2 CATHETER FROM (B)(6). THE ACCOUNT STATED THAT THE PHYSICIAN USED A 16 GA EPIMED INTRODUCING NEEDLE VIA THE S1 FORAMEN TO TARGET SCARRING NEAR L5/S1. WHEN THE PHYSICIAN ENTERED THE S1 FORAMEN, THE TIP OF THE CATHETER GOT STUCK IN THE DORSAL ASPECT OF THE S1 FORAMEN. DESPITE TUGGING ON THE CATHETER, THE PHYSICIAN WAS UNABLE TO DISLODGE IT. BECAUSE OF THIS, THE DECISION WAS MADE TO ATTEMPT TO RETRIEVE THE CATHETER TIP BY DISSECTING DOWN THE LENGTH OF THE CATHETER. SUBSEQUENTLY, THE TIP OF THE CATHETER BROKE OFF AND WAS IRRETRIEVABLE. THE DECISION WAS MADE TO TERMINATE THE PROCEDURE AND THE CATHETER TIP REMAINS IN SITU.
Patient problems: No Information
MAUDE report 7838570 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K954584. One submission often covers many models, so check the product and lot details in each record.
- Z-1276-2021 · Feb 1, 2021 · TerminatedFeth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or le
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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