ARROW IPN923947Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902207439), received between Jul 3, 2023 and Jul 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED VIA MEDWATCH THAT "THE RN EXERTED HIGHER THAN NORMAL TRACTION WHEN REMOVING THE EPIDURAL CATHETER CAUSING IT TO SNAP. PER DISCUSSION WITH THE RN INVOLVED, THE CATHETER FELL OUT AS SHE WAS REMOVING THE DRESSING TAPE. ANESTHESIOLOGIST BELIEVES THE TIP OF THE EPIDURAL CATHETER REMAINS IN THE PATIENT; X-RAY CONFIRMED NO RADIOPAQUE FOREIGN BODY PRESENT". ADDITIONAL INFORMATION RECEIVED STATES THAT "A CT SCAN WAS NOT DONE AS THE PATIENT HAD ALREADY DISCHARGED. X-RAY CONFIRMED NO RADIOPAQUE FOREIGN OBJECT PRESENT. NO MEDICAL INTERVENTION DONE, BUT THE ANESTHESIOLOGIST DID SPEAK WITH THE PATIENT FOR POSSIBLE RETENTION OF A FOREIGN BODY". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17252638 ↗

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-1177-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500
• 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-1238-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
• Z-1236-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
• Z-1237-2020 · Dec 20, 2019 · Terminated
  Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC