ARROW IPN040141Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801902003416), received between Apr 13, 2023 and May 2, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (5 reports).

4 other recalls cover devices cleared under the same FDA submission (K103658); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE DOCTOR FOUND TUBE BLOCKED WHEN USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT." AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 16857135 ↗
• MalfunctionMay 2, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE DOCTOR FOUND TUBE BLOCKED WHEN USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT." AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 16856042 ↗
• MalfunctionApr 20, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE DOCTOR FOUND TUBE BLOCKED WHEN USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT." ADDITIONAL INFORMATION RECEIVED INDICATES THE SNAPLOCK WAS FOUND BLOCKED AFTER INSERTION. THE WHOLE DEVICE WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 16776437 ↗
• MalfunctionApr 20, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE DOCTOR FOUND TUBE BLOCKED WHEN USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". ADDITIONAL I NFORMATION STATES THAT THE "BLOCKAGE WAS FOUND AFTER INSERTION IN THE SNAPLOCK. THE WHOLE DEVICE WAS REPLACED". SEE ASSOCIATED MDR 3006425876-2023-00430.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775990 ↗
• MalfunctionApr 13, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE DOCTOR FOUND TUBE BLOCKED WHEN USING ON PATIENT. THEN CHANGED NEW ONE, NO IMPACT ON PATIENT". ADDITIONAL I NFORMATION STATES THAT THE "BLOCKAGE WAS FOUND AFTER INSERTION IN THE SNAPLOCK. THE WHOLE DEVICE WAS REPLACED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16735036 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103658. One submission often covers many models, so check the product and lot details in each record.

• Z-2364-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;
• Z-1179-2020 · Jan 15, 2020 · Terminated
  FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
• Z-1962-2018 · Apr 11, 2018 · Terminated
  SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
• Z-2462-2015 · Jul 30, 2015 · Terminated
  PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound