FDA Device Intelligence
Home › FERROSAN MEDICAL DEVICES SP Z O O › Certa Catheter

Certa Catheter

FERROSAN MEDICAL DEVICES SP Z O O · Model R50C1 · UDI-DI 05902194190299

BSO Prescription
10
510(k) clearances
2,613
Adverse events (9 deaths)
119
Recalls
54
Facilities

Description

Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of medication for regional anesthesia and pain management in lower extremity blocks. It may be used by a qualified healthcare professional in a perioperative monitored care setting. Certa Catheter™ is intended for use in adult patients only. It should always be inserted and placed under ultrasound guidance by a healthcare professional. The Certa Catheter has not been evaluated for use in upper extremity blocks.

Recalls

DateFirmReason
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2026-03-11ARROW INTERNATIONAL, LLCDue to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
2021-02-01Epimed International, Inc.Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
2020-05-08Arrow International IncNine complaints reported that the rotatable collar on the filter had detached, causing a leak.
2020-01-15Arrow International IncThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
2020-01-15Arrow International IncThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
2020-01-15Arrow International IncThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
2020-01-15Arrow International IncThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
2020-01-15Arrow International IncThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
2020-01-15Arrow International IncThere is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.