ARROW IPN035913Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801902027528), received between Jun 24, 2021 and Jul 2, 2026 — classified as 3 injuries, 7 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K021120); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Material Separation

  IT WAS REPORTED THAT DURING AN ATTEMPTED ARTERIAL CATHETER INSERTION, THE PROCEDURE WAS UNSUCCESSFUL. UPON REMOVAL OF THE CATHETER, IT WAS OBSERVED THAT A PORTION OF THE CATHETER WAS MISSING, INDICATING CATHETER FRACTURE AND RETENTION WITHIN THE PATIENT. AS A RESULT, THE PATIENT UNDERWENT AN EXPLORATORY ARTERIOTOMY TO RETRIEVE THE RETAINED CATHETER FRAGMENT. THE FRAGMENT WAS SUCCESSFULLY REMOVED DURING THE ORIGINALLY SCHEDULED SURGICAL/ANESTHESIA PERIOD. THE PATIENT WAS DISCHARGED ON THE SAME DAY WITHOUT REPORTED COMPLICATIONS OR ADVERSE SEQUELAE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25696161 ↗
• MalfunctionSep 19, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED "SRNA INITIALLY ATTEMPTED TO PLACE L RADIAL ARTERIAL LINE VIA ULTRASOUND GUIDANCE. HE WALKED IN THE ARROW VIA US, GOT ARTERIAL FLASH, AND EASILY THREADED THE WIRE. HOWEVER, THE SRNA THEN REALIZED THAT HE COULD NOT RETRACT THE ARROW FROM THE CATHETER. CRNA ATTEMPTED AND IMMEDIATELY CONFIRMED RESISTANCE TO WITHDRAWING THE ARROW, SO THE ATTENDING MD AND SURGICAL TEAM WERE ALERTED TO THE ISSUE. WE ALSO CALLED THE MCE AIC INTO THE OR. UNDER US GUIDANCE, THE MD & AIC WERE ABLE TO SUCCESSFULLY REMOVE THE INTACT ARROW AND CATHETER, WHICH WAS SIGNIFICANTLY BENT. THERE WAS NO EVIDENCE OF HEMATOMA, PERFUSION COMPROMISE, OR REMAINING COMPONENTS IN THE ARTERY VIA US IMAGING. MD SUBSEQUENTLY PLACED A RADIAL ART VIA US ON THE RUE." 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 23094984 ↗
• InjuryOct 16, 2024Material Separation; Material Separation

  IT WAS INITIALLY REPORTED VIA MEDWATCH REPORT "AN ARTERIAL CATHETER WAS USED TO ACCESS THE LEFT RADIAL ARTERY, AND THE GUIDE WIRE OF THE CATHETER SHEARED AND A FRAGMENT OF IT WAS LODGED ON THE LEFT ARM SOFT TISSUE. VASCULAR SURGERY AND IR WERE CONSULTED, AND NO INTERVENTIONS WERE RECOMMENDED. ADDITIONAL INFORMATION REPORTS "THE PLAN IS FOR THE PATIENT TO HAVE A SURGICAL PROCEDURE TO REMOVE THE RETAINED EQUIPMENT. THE RETAINED INSTRUMENT REMAINS IN THE PATIENT." THE PATIENT'S CURRENT CONDITION IS REPORTS "THE PATIENT IS LIVING AT HOME INDEPENDENTLY AT THIS TIME. FROM THE FOLLOW UP APPOINTMENT NOTES IT STATES THE PATIENT HAS RETURNED TO WORK."

  Patient problems: Foreign Body In Patient

  MAUDE report 20460114 ↗
• MalfunctionApr 1, 2024Crack; Crack

  IT WAS REPORTED "DURING INSERTION THE RED TOP CRACKED". AS A RESULT, ANOTHER DEVICE WAS USED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014114 ↗
• MalfunctionApr 1, 2024Crack; Crack

  IT WAS REPORTED "DURING INSERTION THE RED TOP CRACKED". AS A RESULT, ANOTHER DEVICE WAS USED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014107 ↗
• InjuryJun 29, 2023Material Separation; Material Separation

  CUSTOMER REPORTED "CATHETER FRACTURE". THE INSERTER USED ULTRASOUND AND LOCATED VESSEL IN ARM AND PUNCTURED SKIN AT AN APPROXIMATELY 45 DEGREE ANGLE WITHOUT ANY RESISTANCE. INSERTER DROPPED THE ANGLE SLIGHTLY TO ABOUT 40 DEGREES. GUIDEWIRE WAS ADVANCED WITHOUT RESISTANCE. CATHETER ADVANCED AND WHEN INSERTER WENT TO REMOVE NEEDLE AND GUIDEWIRE MET RESISTANCE. THE INSERTER STOPPED AND THEN ATTEMPTED TO REMOVE IT. USED VERY LITTLE PRESSURE. AT THAT POINT THE INSERTER NOTICED THAT THE CATHETER HAD SHEARED OFF AND ABOUT AN INCH AND A HALF OF THE CATHETER WAS IN THE PATIENT'S ARM. A SMALL INCISION WAS MADE TO PULL THE CATHETER OUT BY VASCULAR SURGERY AT THE PATIENT'S BEDSIDE. THE CATHETER WAS SUCCESSFULLY REMOVED WITHOUT INCIDENT AFTER "GENTLE DISSECTION WITH A SCALPEL, FREEING THE TISSUE OFF THE BUNCHED CATHETER TIP". THE PATIENT'S CURRENT CONDITION IS REPORTED AS FINE. MEDWATCH FORM RECEIVED REPORTS: "AN 80 Y/O MAN REQUIRED THE PLACEMENT OF AN A-LINE FOR HEMODYNAMIC MONITORING. PRIOR TO PROCEDURE, PT'S LEFT RADIAL ARTERY WAS PALPATED AND NOTED TO HAVE +2 PULSES. USING ULTRASOUND, THE PT'S LEFT RADIAL ARTERY WAS VISUALIZED AND NOTED TO BE PULSATILE, APPROX 0.5 CM BELOW THE SKIN. USING T

  Patient problems: Foreign Body In Patient

  MAUDE report 17224780 ↗
• MalfunctionJun 29, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  CUSTOMER REPORTED "CATHETER FRACTURE". THE INSERTER USED ULTRASOUND AND LOCATED VESSEL IN ARM AND PUNCTURED SKIN AT AN APPROXIMATELY 45 DEGREE ANGLE WITHOUT ANY RESISTANCE. INSERTER DROPPED THE ANGLE SLIGHTLY TO ABOUT 40 DEGREES. GUIDEWIRE WAS ADVANCED WITHOUT RESISTANCE. CATHETER ADVANCED AND WHEN INSERTER WENT TO REMOVE NEEDLE AND GUIDEWIRE MET RESISTANCE. THE INSERTER STOPPED AND THEN ATTEMPTED TO REMOVE IT. USED VERY LITTLE PRESSURE. AT THAT POINT THE INSERTER NOTICED THAT THE CATHETER HAD SHEARED OFF AND ABOUT AN INCH AND A HALF OF THE CATHETER WAS IN THE PATIENT'S ARM. A SMALL INCISION WAS MADE TO PULL THE CATHETER OUT BY VASCULAR SURGERY AT THE PATIENT'S BEDSIDE. THE CATHETER WAS SUCCESSFULLY REMOVED WITHOUT INCIDENT AFTER "GENTLE DISSECTION WITH A SCALPEL, FREEING THE TISSUE OFF THE BUNCHED CATHETER TIP". THE PATIENT'S CURRENT CONDITION IS REPORTED AS FINE.MEDWATCH FORM RECEIVED REPORTS:"AN 80 Y/O MAN REQUIRED THE PLACEMENT OF AN A-LINE FOR HEMODYNAMIC MONITORING. PRIOR TO PROCEDURE, PT'S LEFT RADIAL ARTERY WAS PALPATED AND NOTED TO HAVE +2 PULSES. USING ULTRASOUND, THE PT'S LEFT RADIAL ARTERY WAS VISUALIZED AND NOTED TO BE PULSATILE, APPROX 0.5 CM BELOW THE SKIN. USING THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17224706 ↗
• MalfunctionJan 11, 2022Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  COMPLAINT FOUND IN MAUDE DATABASE REPORTED AS: "THE DOCTOR WAS PLACING A RADIAL ARTERIAL LINE. HE COULD NOT ADVANCE CATHETER AND THEN THE CATHETER SPLIT OUT OF THE SIDE OF IT."

  Patient problems: Insufficient Information

  MAUDE report 13226839 ↗
• MalfunctionOct 6, 2021Material Split, Cut or Torn

  THE ARROW ARTERIAL LINE CATHETER HUB SPLIT AFTER INSERTION AND CONNECTION TO PRESSURE BAG. THE CATHETER WAS RE-WIRED TO A LONG TELEFLEX CATHETER WITHOUT PROBLEMS AND CONNECTED TO THE SAME PRESSURE LINE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12582974 ↗
• MalfunctionJun 24, 2021Crack; Crack

  CUSTOMER REPORTED "CATHETER FAILED IN THE PATIENT". IT APPEARED THE HUB WAS CRACKED. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12064413 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021120. 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-1973-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF