ARROW IPN036230Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902122534), received between Oct 8, 2020 and Oct 14, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K914531); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "WHEN TRYING TO PLACE A CENTRAL LINE, THE PROVIDER REMOVED THE GUIDEWIRE AND IT LOST ITS INTEGRITY. AFTER REMOVAL, A PORTION OF IT WAS NOTICED TO BE MISSING FROM THE END. RESISTANCE WAS NOT MET DURING REMOVAL." THE USER CHANGED TO A NEW GUIDEWIRE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20442576 ↗
• InjuryMay 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "DURING A MAC INTRODUCER PLACEMENT, THE FELLOW NEEDED AN ADDITIONAL GUIDE WIRE TO PLACE THE CENTRAL LINE. AN ADDITIONAL GUIDE WIRE OF THE SAME SIZE WAS RETRIEVED FROM THE PROCEDURE CART. AFTER PLACEMENT OF THE CENTRAL LINE, THE GUIDE WIRE WAS REMOVED WITHOUT RESISTANCE. HOWEVER, UPON FURTHER INSPECTION, THE GUIDE WIRE APPEARED TO BE SHORTER IN LENGTH AND UNCOILED AT THE END WITH A SMALLER DIAMETER. THE DISTAL END OF THE GUIDE WIRE WAS VISUALIZED IN THE LEFT IJ VIA ULTRASOUND. IR WAS NOTIFIED AND THE PATIENT WAS TAKEN TO IR FOR FOREIGN BODY REMOVAL. THE DISTAL PORTION OF THE GUIDE WIRE 8 INCHES WAS REMOVED. "MARKED SPRING-WIRE GUIDE WITH ARROW ADVANCER". 0.035 INCH DIAMETER SPRING-WIRE GUIDE (68 CM SWG)" THE PATIENT WAS REPORTED AS "FINE".

  Patient problems: Foreign Body In Patient

  MAUDE report 19320581 ↗
• MalfunctionJan 3, 2024Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT "THE CATHETER DOES NOT SLIDE OVER THE SWG. CLINICAL CONSEQUENCES: NO CLINICAL CONSEQUENCES. THE COMPLAINT WAS ORIGINALLY NON-REPORTABLE, RETURNED DEVICE WAS REVIEWED AND THE COMPLAINT WAS CHANGED TO SWG / CATHETER RESISTANCE - SWG SEPARATED WHICH IS REPORTABLE. MDR AWARE DATE WAS 02JAN2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434925 ↗
• MalfunctionNov 1, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: WHEN THE PACK WAS OPENED THE SWG WAS FOUND TO BE UNRAVELLED. THE ISSUE WAS IDENTIFIED PRIOR TO USE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048687 ↗
• MalfunctionOct 27, 2021Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "GUIDE WIRE HAS UNRAVELED WHEN THE GUIDE WIRE IS PULLED BACK."NO MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707840 ↗
• MalfunctionOct 8, 2020Break; Physical Resistance/Sticking

  THIS REPORT IS REGARDING THE PLACEMENT OF A RIGHT FEMORAL HEMODIALYSIS (HD) LINE. SUMMARY: WIRE SHEARED UPON REMOVAL THROUGH CATHETER. WHILE THE VEIN WAS BEING ACCESSED USING BEDSIDE ULTRASOUND IN THE CRITICAL CARE UNIT, THE WIRE WAS FED INTO NEEDLE WITHOUT ISSUE. THE NEEDLE WAS THEN REMOVED. THE CATHETER WAS PLACED CONFIRMED USING MANOMETRY OVER A FLEXIBLE WIRE. THE WIRE WAS REMOVED. VENOUS BLOOD WAS CONFIRMED ON MANOMETRY [BASED UPON THE PRESSURE]. THE WIRE WAS REINTRODUCED INTO THE FEMORAL VESSEL THROUGH THE MANOMETRY CATHETER. THE WIRE PLACEMENT WAS CONFIRMED WITH ULTRASOUND. SOFT TISSUE WAS DILATED X 2. THE HD CATHETER WAS PLACED OVER WIRE. WHEN THE WIRE WAS ATTEMPTED TO BE PULLED BACK, THERE WAS RESISTANCE. THE OPERATOR TRIED TO CHANGE THE ANGLE. THERE WAS STILL RESISTANCE. CONSEQUENTLY, THE CATHETER WAS PULLED OUT HALFWAY OUT OF THE VESSEL WITH WIRE REMAINING INSIDE THE CATHETER. NEXT, THE WIRE WAS PULLED BACK AND WAS NOTED TO BE SHEARED. THE WIRE COULD NOT BE PULLED BACK FURTHER. IN ENTIRETY, THE CATHETER AND WIRE WERE REMOVED. THE TIP OF THE WIRE WAS STILL INTACT, AND THE MIDDLE OF THE WIRE HAD BEEN SHEARED. A SECOND WIRE WAS USED TO PLACE A CATHETER USING THE SAME ACCESS

  Patient problems: Insufficient Information

  MAUDE report 10648168 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K914531. One submission often covers many models, so check the product and lot details in each record.

• Z-3299-2024 · Jul 26, 2024 · Open, Classified
  Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray