ARROW IPN032649Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 40801902001274), received between May 12, 2026 and Jun 5, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT "DURING THE PROCEDURE OF GAINING ACCESS TO THE PATIENT'S RIGHT INTERNAL JUGULAR (RIJ) VEIN WITH THE INTRODUCER NEEDLE AND 5ML SYRINGE, THE ANESTHESIOLOGIST BECAME AWARE THERE WAS A BLOOD AND AIR MIXTURE IN THE SYRINGE. THE ANESTHESIOLOGIST CONFIRMED WITH ULTRASOUND THAT THE NEEDLE TIP WAS APPROPRIATELY IN THE MIDDLE OF THE VESSEL AND STILL HAVING A BLOOD/AIR MIXTURE. UPON CLOSER REVIEW OF THE NEEDLE, IT WAS NOTED THERE WAS A CRACK IN THE PLASTIC HUB PORTION OF THE STEEL INTRODUCER NEEDLE. THE ANESTHESIA TEAM IMMEDIATELY PROCEEDED TO USE A NEW 9FR INTRODUCER SHEATH WITHOUT ANY ADDITIONAL ISSUE. THE PATIENT'S RIJ HAD TO BE PUNCTURED AGAIN. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND REPLACEMENT WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411608 ↗
• MalfunctionMay 12, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INITIAL INSERTION INTO THE INTERNAL JUGULAR VEIN, A CRACK WAS OBSERVED IN THE INTRODUCER NEEDLE HUB, RESULTING IN LEAKAGE DURING ASPIRATION. THERE WERE NO REPORTS OF PATIENT INJURY OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS STABLE ("FINE"). NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REMOVAL OF THE AFFECTED DEVICE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED SUCCESSFULLY USING AN ALTERNATIVE NEEDLE FROM THE SAME KIT. IT WAS ALSO REPORTED THAT MULTIPLE SIMILAR INCIDENTS INVOLVING CRACKS IN THE INTRODUCER NEEDLE HUB HAVE BEEN IDENTIFIED. IT WAS CONFIRMED THAT NO PATIENTS WERE INJURED IN THESE REPORTED INCIDENTS. IN MOST INSTANCES, PHYSICIANS WERE ABLE TO COMPLETE THE PROCEDURE USING AN ALTERNATIVE NEEDLE AVAILABLE WITHIN THE PSI KIT. ASSOCIATED MDRS INCLUDE (SPECIFIC EVENT) AND 9680794-2026-00375 (MULTIPLE EVENTS WITHOUT ADDITIONAL DETAILS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149995 ↗