ARROW IPN056912Recalls & reported problems
Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen Midline Kit · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902189353), received between Mar 6, 2024 and Mar 6, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K161313); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2024Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn
IT WAS REPORTED THAT: PATIENT CAME TO ED WITH MIDLINE IN PLACE WITH COMPLAINT OF LEAKING FROM EXTENSION LINE. TUBING NOTED TO BE POSSIBLY CUT OR SEPARATED? HOME HEALTH CARING FOR LINE AT PATIENTS' HOME.
Patient problems: Insufficient Information
MAUDE report 18847365 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K161313. One submission often covers many models, so check the product and lot details in each record.
- Z-0102-2023 · Sep 14, 2022 · TerminatedARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intrave
- Z-1818-2019 · Apr 23, 2019 · TerminatedArrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
Other Midline catheter devices
- Midline Catheter Kit P4154108DBard Access Systems, Inc. · Midline catheter1 recall1 death126 reports
- ARROW IPN921959Teleflex Incorporated · Midline catheter2 recalls0 reports
- Midline Catheter Kit S4153108BDPBard Access Systems, Inc. · Midline catheter1 recall36 reports
- Midline Catheter Kit S4153108DBard Access Systems, Inc. · Midline catheter1 recall32 reports
- Midline Catheter Kit S4153108DGPBard Access Systems, Inc. · Midline catheter1 recall15 reports
- Midline Catheter Kit S4254108BDPBard Access Systems, Inc. · Midline catheter1 recall11 reports
- Midline Catheter Kit P4154108Bard Access Systems, Inc. · Midline catheter1 recall10 reports
- ARROW IPN037698Teleflex Incorporated · Midline catheter1 recall9 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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