ARROW IPN055267Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902156065), received between Sep 18, 2021 and Oct 11, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K141051); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "SINCE AUGUST 2022, NEPHROLOGISTS HAVE BEEN COMPLAINING THAT THESE CATHETERS GET QUICKLY BLOCKED. EVEN SO THEY ARE WELL POSITIONED. SO THEY NEED TO BE REPLACED." IT WAS UNKNOWN IF A SPECIFIC LOT# WAS INVOLVED OR THE QUANTITY OF INSTANCES.

  Patient problems: Insufficient Information

  MAUDE report 15582097 ↗
• MalfunctionSep 2, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED AN AIR LEAK WAS OBSERVED IN THE ARTERIAL LINE AND THEN IN THE VENOUS LINE DURING THE 3RD USE ON (B)(6). A SIMILAR AIR LEAK WAS OBSERVED IN THE ARTERIAL LINE ON (B)(6). AT THAT TIME THE DECISION WAS MADE TO REMOVE THE CATHETER. AFTER THE CATHETER WAS REMOVED THERE WAS NO APPARENT CRACK OR LEAK NOTED, BUT IT WAS OBSERVED "THE TIGHTENING RING HAS A CUT ON THE THREAD". IT WAS REPORTED "NO RESTITUTION WAS POSSIBLE (SALINE THAT PUSHED OUT THE BLOOD), SO THERE WAS A DEGLOBULIZATION AND TRANSFUSION". THE PATIENT'S CONDITION WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348096 ↗
• InjuryOct 21, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT "DURING EXTRACTION, THE TIP OF THE SMART SEAL INTRODUCER DETACHED AND REMAINED INSIDE AND MIGRATED INTO THE DISTAL PULMONARY ARTERIAL DISTRICT, WITHOUT APPARENT INSTRUMENTAL (CT ANGIO) AND CLINICAL CONSEQUENCES." IT WAS REPORTED THE SMALL PIECE RETAINED CREATED A PULMONARY MICRO EMBOLISM "RESOLVED WITHOUT PARTICULAR RELIEF". THE TIP REMAINED IN THE PATIENT WITH NO PLANS FOR REMOVAL. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CONDITION IS REPORTED TO BE FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12675824 ↗
• MalfunctionSep 18, 2021Material Separation; Material Separation

  IT WAS REPORTED WHEN THE PHYSICIAN REMOVED THE DILATOR, THE END OF THE DILATOR BROKE AND REMAINED ON THE GUIDE. FORTUNATELY BY REMOVING THE GUIDE THE BROKEN PART OF THE DILATOR COULD BE REMOVED ALSO. NO PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493389 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141051. One submission often covers many models, so check the product and lot details in each record.

• Z-2157-2026 · Apr 10, 2026 · Open, Classified
  Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272