ARROW IPN928656Recalls & reported problems
Teleflex Incorporated · Pressure Injectable One-Lumen Midline · Class 2
All models of ARROW (1494)
Data updated Oct 16, 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 10801902216820), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (1 report).
1 other recall cover devices cleared under the same FDA submission (K213855); 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.
Reports received per month
Most reported problems
Device problems
- Incomplete or Inadequate Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT DURING THE MIDLINE INSERTION, THE PEEL-AWAY SHEATH OVER DILATOR WOULD NOT TWIST AND ENGAGE COMPLETELY. THE PROCEDURE WAS CONTINUED, WITH THE DILATOR/SHEATH NOT FULLY LOCKED TOGETHER. THE CATHETER WAS PLACED SUCCESSFULLY. THE CONDITION OF THE PATIENT IS REPORTED TO BE 'FINE' AND THE PATIENT HAD NO HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21091483 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K213855. One submission often covers many models, so check the product and lot details in each record.
- Z-2387-2026 · Apr 21, 2026 · Open, ClassifiedDescription/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
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 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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