Epimed 156-2112Recalls & reported problems
Epimed International, Inc · Versa-Kath® 21g x 12" · Class 2
Data updated Oct 16, 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 00818788021120), received between Jul 8, 2019 and Jul 8, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Handling Problem1
- Material Split, Cut or Torn1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2019Device Handling Problem; Material Split, Cut or Torn; Device Handling Problem; Material Split, Cut or Torn
ON (B)(6) 2019, (B)(6), MANAGING DIRECTOR AT (B)(6), EMAILED EPIMED REGARDING A SHEARED PORTION OF CATHETER COATING THAT WAS LEFT WITHIN THE PATIENT AT LEVEL C3. THE DOCTOR STATED THAT HE PULLED THE CATHETER TO HARD AGAINST THE NEEDLE WHEN ATTEMPTING TO REPOSITION THE CATHETER.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8768957 ↗
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
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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