AVANTI 504605SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032009966), received between Apr 3, 2026 and Apr 3, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K970392); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Detachment of Device or Device Component

  AS REPORTED, DURING PREPARATION THE LUER HUB OF THE VESSEL DILATOR FOR A 5F 7.5CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) BROKE OFF IN THE SHEATH WHEN REMOVING THE DILATOR. A NEW 5F 7.5CM AVANTI PLUS CSI WAS USED AS A REPLACEMENT. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND WAS STORED IN THE PROCEDURE ROOM PRIOR TO THE PROCEDURE. THE FACILITY DOES NOT USE ROOM STERILIZATION METHODS INVOLVING ULTRAVIOLET (UV) LIGHT OR OZONE. THERE WAS NO VISIBLE DAMAGE TO THE PACKAGE PRIOR TO USE, NO DIFFICULTY INSERTING THE DILATOR INTO THE SHEATH, AND THE LUER HUB OF THE DILATOR DID NOT KINK OR BEND DURING INSERTION. THE DILATOR WAS SNAPPED INTO PLACE AT THE HUB PRIOR TO INSERTION OF THE SHEATH, AND THERE WAS NO DIFFICULTY WITHDRAWING THE DILATOR FROM THE SHEATH PRIOR TO THE SEPARATION OCCURRING. THERE WERE NO REPORTED PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777213 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  AS REPORTED, DURING PREPARATION THE PROXIMAL END OF THE VESSEL DILATOR FOR A 5F 7.5CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) BROKE OFF IN THE SHEATH WHEN REMOVING THE DILATOR. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND IT WAS KEPT IN THE PROCEDURE ROOM PRIOR TO THE PROCEDURE. THE FACILITY DOES NOT USE STERILIZATION METHODS INVOLVING ULTRAVIOLET LIGHT OR O-ZONE. THERE WAS NO VISIBLE DAMAGE TO THE PACKAGING BEFORE USE. NO DIFFICULTY WAS ENCOUNTERED WHEN INSERTING THE DILATOR INTO THE SHEATH, AND THE LUER HUB DID NOT KINK OR BEND DURING INSERTION. THE DILATOR WAS SNAPPED INTO PLACE AT THE HUB. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777127 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  AS REPORTED, THE PROXIMAL END OF THE VESSEL DILATOR FOR A 5F 7.5CM AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI) BROKE OFF IN THE SHEATH WHEN REMOVING THE DILATOR. THERE WERE NO REPORTED PATIENT INJURIES. THE DEVICE WAS STORED AND PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND WAS KEPT IN THE PROCEDURE ROOM PRIOR TO THE PROCEDURE. THE FACILITY DOES NOT USE ROOM STERILIZATION METHODS INVOLVING ULTRAVIOLET LIGHT OR O ZONE. THERE WAS NO VISIBLE DAMAGE TO THE PACKAGING PRIOR TO USE. THERE WAS NO DIFFICULTY INSERTING THE DILATOR INTO THE SHEATH, THE LUER HUB DID NOT KINK OR BEND DURING INSERTION, AND THE DILATOR WAS SNAPPED INTO PLACE AT THE HUB PRIOR TO INSERTION OF THE SHEATH. THE ACCESS VESSEL WAS THE RIGHT FEMORAL VEIN, WHICH WAS NOT CALCIFIED OR TORTUOUS AND HAD NO OTHER NOTED CHARACTERISTICS. NO DIFFICULTY WAS EXPERIENCED DURING INSERTION OF THE SHEATH AND DILATOR INTO THE PATIENT, AND THERE WAS NO DIFFICULTY WITHDRAWING THE DILATOR FROM THE SHEATH PRIOR TO THE SEPARATION OCCURRING. THE DEVICE WILL BE RETURNED FOR EVALUATION ALONG WITH 27 STERILE UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777075 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970392. One submission often covers many models, so check the product and lot details in each record.

• Z-2079-2021 · Jun 9, 2021 · Terminated
  Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
• Z-1174-2016 · Dec 31, 2015 · Terminated
  CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneo