ARROW IPN920005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902192063), received between Sep 17, 2024 and Sep 17, 2024 — classified as 1 malfunction.

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2391-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024

  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 US (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.

  Patient problems: Foreign Body In Patient

  MAUDE report 20235897 ↗

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