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PAINfusor Catheter

PLAN 1 HEALTH S.R.L. · Model 2.5 cm - 1" · UDI-DI 08056459671218

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

Description

The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around a surgical wound size for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous. The PAINfusor Catheter is contraindicated for vascular or epidural drug administration for the delivery and withdrawal of dense fluids like blood, lipids and fat emulsions, and for use in neonatal population.

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.