ARROW IPN036819Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902118889), received between May 18, 2021 and May 7, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 18, 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.

• MalfunctionMay 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THIS IS A DIRECT QUOTE FROM NURSE MANAGER FROM PHYSICIAN OUR INTENSIVIST DR (B)(6) HAS COMPLAINTS ABOUT THE KIT. HE SAYS THE 18G NEEDLE IS TOO BLUNT AND WILL NOT PENETRATE THE ARTERY. THE CATHETER WILL NOT GO THROUGH THE ARTERY EITHER BECAUSE IT'S TOO BLUNT, SO HE HAS TO PUT MORE PRESSURE THAN THE GUIDE WIRE BENDS." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977898 ↗
• InjuryOct 14, 2024Material Frayed; Unraveled Material; Physical Resistance/Sticking; Material Frayed; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT "WHILE INSERTING A CENTRAL VENOUS CATHETER INTO RIGHT FEMORAL SITE, I WAS ALSO TRYING TO INSERT AN ARTERIAL LINE. AFTER VERIFYING THAT MY INTRODUCER NEEDLE WAS IN THE FEMORAL ARTERY PER ULTRASOUND PLUS CLINICAL VERIFICATION PER PULSATING BLOOD RETURN FROM THE ARTERIAL NEEDLE, I INSERTED THE GUIDEWIRE THRU THE NEEDLE. THE GUIDE WIRE WENT IN SMOOTHLY. HOWEVER, WHEN I WAS RETRACTING THE NEEDLE OUT, I ENCOUNTERED RESISTANCE. I MANIPULATED THE GUIDEWIRE (MOVING IT IN AND OUT TO SEE IF THE RESISTANCE WILL DISAPPEAR). THE RESISTANCE IMPROVED; HOWEVER, WHEN I TOTALLY PULLED OUT THE NEEDLE, THE GUIDEWIRE "FRAYED". SINCE THERE WAS RESISTANCE, AS IF THE TIP OF THE GUIDEWIRE IS ANCHORED INSIDE THE SKIN, I DID NOT TRY ANY FURTHER ATTEMPT TO RECOVER THE TIP OF THE GUIDEWIRE. PATIENT WENT TO NEURO IR WHERE THE PATIENT UNDERWENT PIPELINE ASSISTED COIL EMBOLIZATION, ALSO SUCCESSFUL RETRIEVAL OF THE REMNANT OF THE GUIDEWIRE FROM THE RIGHT FEMORAL SITE. THERE WAS NO HEMATOMA, NO VASCULAR COMPROMISE OF THE LEG POST-PROCEDURE. IT WAS REPOR TED "THERE WAS NO PATIENT HARM, THE PATIENT HAS BEEN SAFELY DISCHARGED."

  Patient problems: Foreign Body In Patient

  MAUDE report 20440509 ↗
• InjuryOct 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: " PT HAD A FEMORAL ALINE WHICH WAS INSERTED IN THE ICU ON 9/5. ALINE SITE WITH SIGNIFICANT BLEEDING OVERNIGHT 9/7 TO 9/8 BUT STILL WITH A GOOD WAVEFORM AND READINGS. 9/9 AM, MORE SIGNIFICANT BLEEDING AND CLOTS NOTED AT SITE. PER MD - BEDSIDE RN AND SECOND RN ATTEMPTED TO REMOVE THE A-LINE. SITE VERY BLOODY WITH POOR VISUALIZATION OF THE ACTUAL INSERTION POINT BUT ABLE TO SEE THE WINGS WITH THE SUTURES WELL. SUTURES WERE REMOVED AND A-LINE CATHETER GENTLY PULLED OUT. RNS NOTED THAT ONLY A SMALL PIECE OF THE CATHETER WAS PRESENT. AFTER BLEEDING STOPPED, UNABLE TO SEE ANY OTHER FRAGMENT OF THE CATHETER. THE OTHER PORTION OF THE CATHETER IS STILL INDWELLING IN THE FEMORAL VEIN. THE PATIENT MAY BE HAVING IT REMOVED IN INTERVENTIONAL RADIOLOGY SOON." AWAITING ADDITIONAL INFORMATION FROM THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20342585 ↗
• MalfunctionFeb 23, 2024Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT: INSERTING ARTERIAL LINE COULD NOT PASS GUIDEWIRE MET RESISTANCE PULLED GUIDEWIRE BACK, IT CAME BACK AND THEN STOPPED REMOVED NEEDLE GUIDEWIRE PULLED BACK BUT IN THIN STRAND WITHOUT TIP INTACT NO J POINT SEEN. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767140 ↗
• MalfunctionDec 12, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT: GUIDEWIRE PASSED THROUGH NEEDLE , IT GOT STUCK AND THEN THE NEEDLE AND GUIDEWIRE WERE REMOVED TOGETHER. WHEN REMOVED THE WIRE WAS UNRAVELLED. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT BUT THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18308870 ↗
• MalfunctionMay 18, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTED THE GUIDEWIRE BENT UPON INITIAL INSERTION. THE USER WAS UNABLE TO INSERT IT INTO CATHETER TO THREAD LUMEN AND PLACE LINE. NO INJURY WAS CAUSED TO THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842372 ↗