HIgH-Flo™ Needle Set RMS52609Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00659443000452), received between Oct 24, 2024 and Oct 24, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K122404, K200176, K211206, K214045, K252015); 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  KORU MEDICAL BECAME AWARE OF 2 NEEDLE STICK REPORTS INVOLVING KORU HIGH FLO SUBCUTANEOUS SAFETY NEEDLE SETS. IN BOTH CASES, THE NEEDLE SETS HAD BEEN USED ON PATIENTS. MDR 1318360-2024-00008 IS BEING FILED FOR NURSE #1, NEEDLE STICK/PUNCTURE REPORT. ADDITIONAL INFORMATION WAS RECEIVED FOR NURSE#2 ON (B)(6) 2024 STATING THE NURSE REMOVED THE INFUSION NEEDLES FROM THE PATIENT AND EACH NEEDLE WAS SNAPPED SHUT UPON REMOVAL (HEARD THE SNAP). WHILE DISPOSING OF THE INFUSION SET, ONE OF THE NEEDLES OPENED UP AND THE NURSE WAS PUNCTURED ON THE RIGHT INDEX FINGER. THE DATE OF OCCURRENCE FOR THIS EVENT IS (B)(6) 2024. MDR 1318360-2024-00009 IS BEING FILED FOR THE FIRST OCCURRENCE INVOLVING NURSE #2. WHILE TEACHING THE PATIENT THE FOLLOWING DAY ((B)(6) 2024), ALL NEEDLE WINGS AUDIBLY SNAPPED SHUT AND ONE REOPENED AFTER REMOVAL AND SNAPPING. A NEEDLE STICK DID NOT OCCUR IN THIS CASE. THIS MDR IS BEING FILED FOR THE SECOND OCCURRENCE WITH NURSE #2. THE NURSE WAS WEARING PPE (GLOVES) AT THE TIME THE EVENTS OCCURRED. THE NURSE FOLLOWED THE COMPANY'S PROTOCOL FOR REPORTING, EVALUATION, ETC. NO ADVERSE EVENT OUTCOMES WERE REPORTED TO HAVE OCCURRED. THE INITIAL REPORTER DID NOT PROVIDE ANY IDENTIFYIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20528469 ↗
• MalfunctionOct 24, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  KORU MEDICAL BECAME AWARE OF 2 NEEDLE STICK REPORTS INVOLVING KORU HIGH FLO SUBCUTANEOUS SAFETY NEEDLE SETS. IN BOTH CASES, THE NEEDLE SETS HAD BEEN USED ON PATIENTS. MDR 1318360-2024-00008 IS BEING FILED FOR NURSE #(B)(4), NEEDLE STICK/PUNCTURE REPORT. ADDITIONAL INFORMATION WAS RECEIVED FOR NURSE#(B)(4) ON (B)(6)2024 STATING THE NURSE REMOVED THE INFUSION NEEDLES FROM THE PATIENT AND EACH NEEDLE WAS SNAPPED SHUT UPON REMOVAL (HEARD THE SNAP). WHILE DISPOSING OF THE INFUSION SET, ONE OF THE NEEDLES OPENED UP AND THE NURSE WAS PUNCTURED ON THE RIGHT INDEX FINGER. THE DATE OF OCCURRENCE FOR THIS EVENT IS (B)(6)2024. WHILE TEACHING THE PATIENT THE FOLLOWING DAY ((B)(6)2024), ALL NEEDLE WINGS AUDIBLY SNAPPED SHUT AND ONE REOPENED AFTER REMOVAL AND SNAPPING. A NEEDLE STICK DID NOT OCCUR IN THIS CASE. MDR 1318360-2024-00010 IS BEING FILED FOR THE SECOND OCCURRENCE WITH NURSE #(B)(4). THE NURSE WAS WEARING PPE (GLOVES) AT THE TIME THE EVENTS OCCURRED. THE NURSE FOLLOWED THE COMPANY'S PROTOCOL FOR REPORTING, EVALUATION, ETC. NO ADVERSE EVENT OUTCOMES WERE REPORTED TO HAVE OCCURRED. THE INITIAL REPORTER DID NOT PROVIDE ANY IDENTIFYING INFORMATION FOR THE NURSE DUE TO CONFIDENTIALITY. THE L

  Patient problems: Needle Stick/Puncture

  MAUDE report 20527801 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122404, K200176, K211206, K214045, K252015. One submission often covers many models, so check the product and lot details in each record.

• Z-0051-2020 · Aug 20, 2019 · Terminated
  20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery
• Z-0318-2018 · Mar 10, 2016 · Terminated
  HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS1