HydroMID MID-141Recalls & reported problems
Access Vascular, Inc. · Midline catheter · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00862559000449), received between Jun 18, 2021 and Sep 7, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).
3 other recalls cover devices cleared under the same FDA submission (K203069); 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
- Improper or Incorrect Procedure or Method2
- Complete Blockage1
- Infusion or Flow Problem1
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2021Complete Blockage; Complete Blockage
THE COMPLAINANT REPORTED THAT WHEN THE HYDROPICC WAS REMOVED, A "HUGE CLOT WAS IN/ON THE CATHETER" AND WAS COMPLETELY OCCLUDED.
Patient problems: Insufficient Information
MAUDE report 12433180 ↗MalfunctionAug 25, 2021Infusion or Flow Problem; Infusion or Flow Problem
THE CLINICIAN REPORTED THAT THE HYDROMID CATHETER HAD OCCLUDED THE DAY AFTER IT WAS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 12366665 ↗MalfunctionJun 25, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE CLINICIAN REPORTED THAT THE HYDROMID CATHETER HAD OCCLUDED.
Patient problems: Insufficient Information
MAUDE report 12069895 ↗MalfunctionJun 18, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE CLINICIAN REPORTED THAT THE HYDROMID CATHETER HAD OCCLUDED 2 DAYS AFTER BEING IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 12023156 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K203069. One submission often covers many models, so check the product and lot details in each record.
- Z-1156-2023 · Dec 22, 2022 · Open, ClassifiedHydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
- Z-1155-2023 · Dec 22, 2022 · Open, ClassifiedHydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 8000
- Z-1129-2023 · Dec 16, 2022 · Open, ClassifiedHydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Other Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 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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