ARROW IPN031491Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801902009913), received between Mar 9, 2021 and May 12, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K810962); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  IT WAS REPORTED "CENTRAL CATHETER INSERTED IN ACCORDANCE WITH IFU. A CENTRAL CATHETER WAS INSERTED WITHOUT ULTRASOUND CONTROL; NO SKIN INCISION WAS MADE. CANNULATION SITE HAD NO SCARRING. CANNULATION PROCEEDED CORRECTLY UNTIL THE GUIDEWIRE WAS REMOVED THROUGH THE CENTRAL CATHETER. THERE WAS NO RESISTANCE DURING INSERTION OF THE CATHETER OR GUIDEWIRE. DURING REMOVAL OF THE GUIDEWIRE THROUGH THE CATHETER, THE GUIDEWIRE DELAMINATED AND KINKED. X-RAY AND GUIDEWIRE AFTER REMOVAL ATTACHED. SURGICAL REMOVAL OF THE SWG TOGETHER WITH THE CATHETER. VENESECTION OF THE JUGULAR VEIN BY SURGEONS. NEW CATHETER PLACEMENT." THE PATIENT'S CURRENT CONDITION WAS ORIGINALLY REPORTED AS "FINE". HOWEVER, ADDITIONAL INFORMATION REPORTS THE PATIENT IS "DECEASED". IT WAS REPORTED "THE CVC WAS NOT THE CAUSE OF PATIENT'S DEATH". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00456.

  Patient problems: Foreign Body In Patient

  MAUDE report 22003519 ↗
• MalfunctionMay 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "CENTRAL CATHETER INSERTED BY SURGEONS ON THE OPERATING TABLE. JUGULAR VEIN VENECTOMY WAS PERFORMED. AFTER ABOUT A DAY, IT WAS NOTICED THAT THE CATHETER WAS LEAKING. SLIGHT DAMAGE TO THE BODY OF THE CENTRAL CATHETER. THE CATHETER WAS LEAKING ABOUT THE LAST CENTIMETER. THE CATHETER WAS REMOVED. THE CATHETER IS WAITING TO BE COLLECTED." THE PATIENTS CURRENT CONDITION WAS ORIGINALLY REPORTED AS "FINE". HOWEVER, ADDITIONAL INFORMATION REPORTS THE PATIENT IS NOW "DECEASED". IT WAS REPORTED "THE CVC WAS NOT THE CAUSE OF PATIENT'S DEATH". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00455 AND 3006425876-2025-00456.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003487 ↗
• MalfunctionDec 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT: THE PHYSICIAN INSERTED THE INTRODUCER NEEDLE IN FEMORAL VEIN AND ADVANCED THE GUIDEWIRE AND THE CATHETER OVER THE WIRE WITHOUT ANY PROBLEMS. WHEN SHE RETRIEVED THE GUIDEWIRE, THE CATHETER KINKS AND COMES OUT TOGETHER WITH THE GUIDEWIRE. SHE THEN INSERTED IT SUCCESSFULLY IN THE JUGULAR VEIN AFTER 3 ATTEMPTS. SHE USED A 22 GA IN JUGULAR VEIN. ASSOCIATED COMPLAINTS 3006425876-2023-01177, 3006425876-2023-01175 AND 3006425876-2023-01176.

  Patient problems: Insufficient Information

  MAUDE report 18299463 ↗
• MalfunctionDec 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT: THE PHYSICIAN INSERTED THE INTRODUCER NEEDLE IN FEMORAL VEIN AND ADVANCED THE GUIDEWIRE AND THE CATHETER OVER THE WIRE WITHOUT ANY PROBLEMS. WHEN SHE RETRIEVED THE GUIDEWIRE, THE CATHETER KINKS AND COMES OUT TOGETHER WITH THE GUIDEWIRE. SHE THEN INSERTED IT SUCCESSFULLY IN THE JUGULAR VEIN AFTER 3 ATTEMPTS. SHE USED A 22 GA IN JUGULAR VEIN. ASSOCIATED COMPLAINTS 3006425876-2023-01177, 3006425876-2023-01175 AND 3006425876-2023-01176.

  Patient problems: Insufficient Information

  MAUDE report 18299417 ↗
• MalfunctionMar 9, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: "PATIENT IS A NEW BORN BABY. A CENTRAL CATHETER WAS INSERTED IN SURGERY ROOM IN JUGULAR ON (B)(6) 2021. THE BABY WAS SENT BACK TO HIS ROOM. THE BANDAGE WAS NOT FULLY COVERING, THE PRESSURE VALVE WAS VISIBLE. WE PERFORMED A X RAY IN THE ROOM, THE CHILD WAS A BIT AGITATED. WHILST REMOVING THE X RAY PLAQUE, THE BANDAGE WAS SLIGHTLY OPENED AND THE CATHETER WAS OUT. THIS EVENT WAS REPORTED TO THE DOCTOR. THE DOCTOR ASKED TO REMOVE THE BANDAGE FROM THE CATHETER. WHEN WE REMOVED THE BANDAGE, THE JUNCTURE HUB WAS PROPERLY ATTACHED BUT THE CATHETER WAS SEPARATED FROM THE HUB. THE CATHETER SLID AND WENT OUT OF THE SKIN. A DRY BANDAGE WAS APPLIED. DOCTORS DECIDED TO SEND THE CHILD TO SURGERY ROOM TO INSERT A NEW CATHETER."

  Patient problems: Insufficient Information

  MAUDE report 11447843 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K810962. 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
• Z-1960-2018 · Apr 11, 2018 · Terminated
  Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418