ARROW IPN046734Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902030228), received between Nov 10, 2021 and Aug 29, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (2 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.

• MalfunctionAug 29, 2024Break; Break

  IT WAS REPORTED "ON (B)(6) 2024, IN THE CARDIOVASCULAR SURGERY UNIT, THE PLASTIC SHEATH OF THE CATHETER BROKE AFTER SLIDING IT, BUT THE METAL PART REMAINED INTACT. IT WAS NECESSARY TO MAKE AN INCISION AT THE PUNCTURE POINT TO RECOVER THE PLASTIC SHEATH. A CONTROL X-RAY WAS PERFORMED WITH NO FURTHER CONSEQUENCES FOR THE PATIENT." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20097840 ↗
• MalfunctionMar 8, 2022Obstruction of Flow; Obstruction of Flow

  TWO CATHETERS WERE BLOCKED.

  Patient problems: Insufficient Information

  MAUDE report 13693088 ↗
• MalfunctionMar 8, 2022Obstruction of Flow; Obstruction of Flow

  TWO CATHETERS WERE BLOCKED.

  Patient problems: Insufficient Information

  MAUDE report 13693012 ↗
• MalfunctionDec 28, 2021Leak/Splash; Leak/Splash

  PLACEMENT OF A PERIDURAL ANESTHESIA USING THE LOSS OF RESISTANCE TECHNIQUE. NO ADEQUATE RESISTANCE FELT WHEN ADVANCING SYRINGE PLUNGER. DURING INSPECTION OF THE NEEDLE WHEN CONNECTING A NACL SYRINGE AND CLOSURE OF THE DISTAL END OF THE NEEDLE IT WAS NOTED THAT FLUID LEAKED FROM THE SIDE OF THE CONNECTOR. NO PATIENT INJURY. TERMINATION OF THE PROCEDURE AND CHANGE TO A NEW SET. ADDITIONAL INFORMATION: THERE WAS NO VISIBLE DEFECT ON THE OUTSIDE. THE LEAKAGE OF LIQUID IN CASE OF RESISTANCE AT THE END OF THE NEEDLE OCCURRED AT THE SEAM OF THE PLASTIC ELEMENTS THAT WERE WELDED TOGETHER. THERE WAS NO PATIENT HARM; PROCEDURE INTERRUPTED BY ATTENTIVE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13097552 ↗
• MalfunctionNov 10, 2021Defective Device; No Flow; Defective Device; No Flow

  THE CATHETER IS NOT CONTINUOUS, NOT OPEN. NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789596 ↗

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