ARROW IPN928006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902214987), received between Jan 5, 2024 and Jan 24, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K171146); 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2024Pressure Problem; Pressure Problem

  IT WAS REPORTED "[SHORTLY AFTER INSERTION] ITS WAVEFORM WAS DAMPENING. IT IS NOW A FLAT NON EXISTENT WAVEFORM. IT IS AS WELL IN A FEMORAL ARTERY. IT IS STILL IN SO WE CAN AT LEAST GET BLOOD OFF OF IT." NO INJURY OR CONSEQUENCE REPORTED. NO MEDICAL INTERVENTION REQUIRED. PATIENT CONDITION REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576070 ↗
• MalfunctionJan 5, 2024Product Quality Problem; Product Quality Problem

  CUSTOMER OPENED KIT AND FOUND THERE TO BE AN EXTRA CATHETER OF ONE SIZE AND NO CATHETER OF THE OTHER SIZE. CUSTOMER DID NOT SPECIFY WHAT SIZE WAS DUPLICATED OR MISSING. SHE THEN HAD TO OPENED A SECOND KIT AND FOUND THE SAME ISSUE. THE THIRD KIT WAS FINE. ASSOCIATED TO 9680794-2024-00032.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452945 ↗
• MalfunctionJan 5, 2024Product Quality Problem; Product Quality Problem

  CUSTOMER OPENED KIT AND FOUND THERE TO BE AN EXTRA CATHETER OF ONE SIZE AND NO CATHETER OF THE OTHER SIZE. CUSTOMER DID NOT SPECIFY WHAT SIZE WAS DUPLICATED OR MISSING. SHE THEN HAD TO OPENED A SECOND KIT AND FOUND THE SAME ISSUE. THE THIRD KIT WAS FINE. THE REPORTED DEFECT WAS DETECTED PRIOR TO USE (IN A CLINICAL SETTING). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452609 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171146. One submission often covers many models, so check the product and lot details in each record.

• Z-2377-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE