Epimed International, Inc. 181-2112Recalls & reported problems
Epimed International, Inc · Versa-Kath® 21g x 12" w/ RX Coudé 18g TW x 3.5" · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818788021397), received between Feb 1, 2019 and Feb 1, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K023140); 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 18, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 1, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
"THE HOSPITAL INFORMED US THAT GRAY COATING PART OF THE TWO PRODUCTS IS DIFFERENT FROM THE OLDER VERSIONS. SO, WE RANDOMLY CHECKED THESE PRODUCTS IN THE BOX AND WE FOUND THAT THE GRAY COATING OF THE OLD VERSION'S PRODUCT IS COVERED UP TO THE FRONT OF THE SPRING, BUT THE LATEST VERSION'S GRAY COATING IS IRREGULAR LENGTH. SOME ARE SHORT AND SOME ARE LONG, WE CANNOT FIGURE OUT HOW MANY QUANTITIES ARE DIFFERENT FROM OLDER VERSION. SERIOUSLY, THE HOSPITAL IS FACED WITH AN UNEXPECTED SERIOUS SITUATION NOW. THE PATIENT BECAME NEUROLEPSIS."
Patient problems: Patient Problem/Medical Problem
MAUDE report 8298857 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K023140. One submission often covers many models, so check the product and lot details in each record.
- Z-2068-2019 · Jun 18, 2019 · TerminatedVersa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anest
- Z-2069-2019 · Jun 18, 2019 · TerminatedVersa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesth
Other CATHETER, CONDUCTION, ANESTHETIC devices
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- ARROW IPN924999Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC3 recalls0 reports
- ARROW IPN924964Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls1 report
- ARROW IPN925052Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN924975Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN922619Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN925020Teleflex Incorporated · CATHETER, CONDUCTION, ANESTHETIC2 recalls0 reports
- ARROW IPN927743Teleflex 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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