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ARROW IPN037106Recalls & reported problems

Teleflex Incorporated · Central Venous Catheterization Kit · Class 2 · Implant

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902121636), received between Mar 22, 2023 and Mar 22, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (4 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

  1. Apr 21, 2026Open, Classified

    Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

    Z-2368-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

  2. Apr 21, 2026Open, Classified

    Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

    Z-2396-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Deformation Due to Compressive Stress4

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.

  • MalfunctionMar 22, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    IT WAS REPORTED "GUIDEWIRE IS BENT AND HAVING TO OPEN SEVERAL KITS". NO FURTHER EVENT DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT.

    Patient problems: Insufficient Information

    MAUDE report 16589945 ↗
  • MalfunctionMar 22, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    IT WAS REPORTED "GUIDEWIRE IS BENT AND HAVING TO OPEN SEVERAL KITS". NO FURTHER EVENT DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT.

    Patient problems: Insufficient Information

    MAUDE report 16589913 ↗
  • MalfunctionMar 22, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    IT WAS REPORTED "GUIDEWIRE IS BENT AND HAVING TO OPEN SEVERAL KITS". NO FURTHER EVENT DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT.

    Patient problems: Insufficient Information

    MAUDE report 16589898 ↗
  • MalfunctionMar 22, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    IT WAS REPORTED "GUIDEWIRE IS BENT AND HAVING TO OPEN SEVERAL KITS". NO FURTHER EVENT DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT.

    Patient problems: Insufficient Information

    MAUDE report 16589885 ↗

Other Syringe, piston devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.