ARROW IPN046495Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902070194), received between Feb 10, 2021 and Jan 28, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "THE 17G TUOHY IS BENDING AS SOON AS THEY TRY TO INSERT IT." THE ISSUE OCCURED ON 2 DIFFERNT OCCASIONS WITH DIFFERNT PATIENTS. ASSOCIATED CONMPLAITNS 9680794-2025-00019 AND 9680794-2025-00021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21250464 ↗
• MalfunctionJan 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "THE 17G TUOHY IS BENDING AS SOON AS THEY TRY TO INSERT IT." THE ISSUE OCCURED ON 2 DIFFERNT OCCASIONS WITH DIFFERNT PATIENTS. ASSOCIATED CONMPLAITNS 9680794-2025-00019 AND 9680794-2025-00021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21250311 ↗
• MalfunctionFeb 10, 2021Break; Break

  THE PATIENT ADMITTED FOR LABOR REQUESTING LABOR EPIDURAL. DURING EPIDURAL PLACEMENT: FIRST ATTEMPT AT L3/4 WITH CRISP LOSS AT 6CM. DPE PERFORMED. 25G WHITACARE NEEDLE THROUGH 17G TUOHY. CLEAR CSF RETURN BUT PATIENT ENDORSES L PARESTHESIA. NO ATTEMPT MADE AT THREADED CATHETER. REDIRECTED NEEDLE MORE MIDLINE, CRISP LOSS AT 6CM BUT UNABLE TO THREAD CATHETER. TUOHY NEEDLE PULLED BACK TO SKIN AND REDIRECTED CEPHALAD AT L3/4. CRISP LOSS AT 6CM. THREADED CATHETER BUT AGAIN PATIENT ENDORSED L PARESTHESIA WITH THREADING. DECISION MADE TO ABORT AND TRY ANOTHER LEVEL. TUOHY REMOVED. RESISTANCE MET WITH PULLING BACK CATHETER. CATHETER REMOVED WITH MILD INCREASE IN TRACTION BUT TIP NOT INTACT ABOUT 1CM NOTED TO BE MISSING. PATIENT DENIED PERSISTENT PARESTHESIA'S AND NO FOREIGN BODY NOTED AT SKIN. INFORMED PATIENT, LABOR RN AND OB ABOUT RETAINED FOREIGN BODY. CONSULTED NEUROSURGERY WHO RECOMMENDED XR IMAGING OF BACK AFTER DELIVERY OF NEONATE. CT ABDOMEN SHOWED 6MM L EPIDURAL DENSITY AT L3-4, SUSPICIOUS FOR RETAINED EPIDURAL CATHETER TIP. NEUROSURGERY EVALUATED AND DECIDED WITH PATIENT THAT OBSERVATION IS THE BEST COURSE OF ACTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307743 ↗

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-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