AVANTI 504611XRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705032010252), received between Nov 5, 2019 and Dec 3, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HEMOSTASIS VALVE OF AN 11F 11CM AVANTI+ CATHETER SHEATH INTRODUCER (CSI) SEPARATED FROM THE CATHETER AND WAS NOTED ON THE CORONARY SINUS CATHETER AFTER REMOVAL AND THERE WAS NO WAY TO PREVENT BACK BLEEDING AND SUBSTANTIAL BLOOD LOSS OTHER THAN QUICKLY REMOVING THE REST OF THE CATHETER PREMATURELY FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THIS FAILURE OCCURRED WHEN REMOVING CORONARY SINUS CATHETERS AT THE CONCLUSION OF THE CASE. THE CATHETER WAS PREPPED CORRECTLY BY THE OR STAFF. THE PROCEDURE WAS ALREADY COMPLETE WHEN THIS EVENT OCCURRED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709074 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HEMOSTASIS VALVE OF AN 11F 11CM AVANTI+ CATHETER SHEATH INTRODUCER (CSI) SEPARATED FROM THE CATHETER AND WAS NOTED ON THE CORONARY SINUS CATHETER AFTER REMOVAL AND THERE WAS NO WAY TO PREVENT BACK BLEEDING AND SUBSTANTIAL BLOOD LOSS OTHER THAN QUICKLY REMOVING THE REST OF THE CATHETER FROM THE PATIENT PREMATURELY. THERE WAS NO REPORTED PATIENT INJURY. THIS FAILURE OCCURRED WHEN REMOVING CORONARY SINUS CATHETERS AT THE CONCLUSION OF THE CASE. THE CATHETER WAS PREPPED CORRECTLY BY THE OR STAFF. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709016 ↗
• MalfunctionDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, TWO PARTS OF AN 11F 11CM AVANTI+ CATHETER SHEATH INTRODUCER (CSI) SEPARATED FROM EACH OTHER AND THE CSI REPORTEDLY FAILED PART WAY THROUGH ROBOTIC CARDIAC SURGERY PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. PACKAGING AND LOT NUMBERS WERE NOT AVAILABLE FOR RETRIEVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697501 ↗
• InjuryJan 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AN 11F STANDARD AVANTI + SHEATH INTRODUCER WITH MINI GUIDEWIRE BROKE INSIDE THE PATIENT. THE CLINICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE AND CONTINUE WITH THE CASE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464187 ↗
• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TEN 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW) AND ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW) CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE ELEVEN DEVICES WERE RETURNED FOR EVALUATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280470 ↗
• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TWO 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW), ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW), AND 11 UNKNOWN 8F AVANTI + CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280461 ↗
• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TWO 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW), ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW), AND 11 UNKNOWN 8F AVANTI + CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280448 ↗
• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TEN 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW) AND ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW) CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE ELEVEN DEVICES WERE RETURNED FOR EVALUATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280439 ↗
• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TEN 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW) AND ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW) CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE ELEVEN DEVICES WERE RETURNED FOR EVALUATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280426 ↗
• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TEN 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW) AND ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW) CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE ELEVEN DEVICES WERE RETURNED FOR EVALUATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280425 ↗
• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TEN 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW) AND ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW) CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE ELEVEN DEVICES WERE RETURNED FOR EVALUATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280419 ↗
• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TEN 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW) AND ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW) CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE ELEVEN DEVICES WERE RETURNED FOR EVALUATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280416 ↗
• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TWO 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW), ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW), AND 11 UNKNOWN 8F AVANTI + CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280406 ↗
• MalfunctionNov 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, TWO 11F AVANTI PLUS STANDARD WITH GUIDEWIRE (W/GW), ONE 0.035 8F AVANTI PLUS WITHOUT GUIDEWIRE (W/O GW), AND 11 UNKNOWN 8F AVANTI + CATHETER SHEATH INTRODUCER (CSI) HAD AN EXCESS OILY SUBSTANCE NEAR THE HUB. THE PRODUCTS WERE STORED AS PER LABELING. THE DEVICES WERE OPENED IN STERILE FIELD. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED IN THE LAB IN A CONTROLLED ENVIRONMENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE INTEGRITY OF THE STERILE POUCHES WAS NOT COMPROMISED. THE DAMAGE WAS NOTED AFTER IT HAD BEEN RECEIVED AND STORED IN THE LAB PRIOR TO USING AND UPON INITIAL RECEIPT OF THE PRODUCT. THE PRODUCTS WERE USED IN THE PATIENT. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280390 ↗

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