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ARROW IPN046629 (REF SJ-05501)Recalls & reported problems

Teleflex Incorporated · Epidural Catheterization Kit with FlexTip Plus(R), Open Tip Single-Port Catheter and Needle Disposal Feature · 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 10801902013696), received between Apr 26, 2023 and Apr 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K140110); 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

  • Material Separation1

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.

  • MalfunctionApr 26, 2023Material Separation; Material Separation

    IT WAS REPORTED THAT WHEN THE EPIDURAL CATHETER WAS REMOVED, OUTSIDE OF THE PATIENT'S BODY, IT BROKE IN TWO DIFFERENT SPOTS. ALL BROKEN PIECES WERE ACCOUNTED FOR. NO PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "OK".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16819428 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140110. One submission often covers many models, so check the product and lot details in each record.

  • Z-2371-2026 · Apr 21, 2026 · Open, Classified
    Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION K
  • Z-1913-2026 · Mar 11, 2026 · Open, Classified
    FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arr
  • Z-2288-2020 · May 8, 2020 · Open, Classified
    Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05
  • Z-1174-2020 · Jan 15, 2020 · Terminated
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
  • Z-1172-2020 · Jan 15, 2020 · Terminated
    FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501
  • Z-1177-2020 · Jan 15, 2020 · Terminated
    FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
  • Z-1237-2020 · Dec 20, 2019 · Terminated
    Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
  • Z-1236-2020 · Dec 20, 2019 · Terminated
    Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
  • Z-1238-2020 · Dec 20, 2019 · Terminated
    Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN

Other CATHETER, CONDUCTION, ANESTHETIC devices

All CATHETER, CONDUCTION, ANESTHETIC devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page