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ARROW

TELEFLEX INCORPORATED · Model IPN046573 · UDI-DI 20801902012269

BSO Prescription
1
510(k) clearances
2,605
Adverse events (9 deaths)
119
Recalls
54
Facilities

Description

FlexTip Plus(R) Epidural Catheterization Kit

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.

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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.