ARROW IPN045667Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902075130), received between Mar 26, 2022 and Mar 26, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Flow” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2022No Flow; No Flow

  APPROXIMATELY 13 INSTANCES IN THE MONTH OF MARCH 2 WERE FOUND TO BE UNABLE TO PUSH MEDICATIONS THROUGH AFTER BEING PLACED. THE DOCTOR'S INITIAL TEXTS WHICH WERE FORWARDED TO MARKETING AND ENGINEERING: JUST WONDERING WHETHER Y'ALL HAVE CHANGED THE POLYURETHANE MATERIAL AROUND THE WIRE REINFORCED CATHETER. IT SEEMS STIFFER AND KEEPS CAUSING PARASTHESIAS. WE ARE HAVING A LOT OF PROBLEMS WITH THE CATHETERS. KINKS, CLOTS, CANNOT THREAD, OR TOO TOUGH. THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13923962 ↗
• MalfunctionMar 26, 2022No Flow; No Flow

  APPROXIMATELY 13 INSTANCES IN THE MONTH OF MARCH 2 WERE FOUND TO BE UNABLE TO PUSH MEDICATIONS THROUGH AFTER BEING PLACED. THE DOCTOR'S INITIAL TEXTS WHICH WERE FORWARDED TO MARKETING AND ENGINEERING: JUST WONDERING WHETHER Y'ALL HAVE CHANGED THE POLYURETHANE MATERIAL AROUND THE WIRE REINFORCED CATHETER. IT SEEMS STIFFER AND KEEPS CAUSING PARASTHESIAS. WE ARE HAVING A LOT OF PROBLEMS WITH THE CATHETERS. KINKS, CLOTS, CANNOT THREAD, OR TOO TOUGH. THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13923952 ↗

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-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-1174-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
• 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