HydroMID Maximal Barrier Kit 80004004Recalls & reported problems
Access Vascular, Inc. · Midline Catheter (Maximal Barrier Kit) · Class 2 · Implant
All models of HydroMID Maximal Barrier Kit (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850030354020), received between Jul 13, 2022 and Jan 9, 2024 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
1 other recall 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 18, 2026.
Reports received per month
Recalls naming this device
- Dec 22, 2022Class IIOpen, Classified
Product Mislabeled on the outer bag and inner kit Tyvek header bag
Z-1155-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 22, 2022Class IIOpen, Classified
Label with the incorrect component listed on the inner kit Tyvek header bag
Z-1156-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
- Off-Label Use1
Patient problems
- Insufficient Information2
- Thrombosis/Thrombus2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER REPORTED A RUPTURED MIDLINE.
Patient problems: Insufficient Information
MAUDE report 18475569 ↗InjuryJun 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CUSTOMER NOTIFIED AVI VIA TEXT THAT SAID, "GOT A MID THAT SPLIT." THE ACCOMPANYING PHOTO REVEALED A DEFECT IN THE CATHETER WALL THAT APPEARED TO BE LEAKING FLUID.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17079216 ↗MalfunctionSep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUSPECTED DEEP VEIN THROMBOSIS (DVT) POST MIDLINE PLACEMENT.
Patient problems: Thrombosis/Thrombus
MAUDE report 15517249 ↗MalfunctionSep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUSPECTED DEEP VEIN THROMBOSIS (DVT) POST MIDLINE PLACEMENT.
Patient problems: Thrombosis/Thrombus
MAUDE report 15474019 ↗MalfunctionJul 13, 2022Off-Label Use; Off-Label Use
HYDROMID WAS UNABLE TO ASPIRATE OR FLUSH. WHEN THE LINE WAS REMOVED, IT WAS NOTED THAT AN AREA OF THE CATHETER EXPERIENCED FATIGUE AND ANOTHER AREA HAD BURST.
Patient problems: Insufficient Information
MAUDE report 15000408 ↗
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-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
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- 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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