Adelante Breezeway AB081045Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672101787), received between Nov 11, 2019 and Nov 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

30 other recalls cover devices cleared under the same FDA submission (K101497); 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 18, 2026.

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.

• MalfunctionNov 11, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION OF THROMBECTOMY PROCEDURE USER FIND INTERNAL DILATOR WAS SHORT FOR THE SHEATH WHICH CAUSE STEPDOWN FROM THE OPENING IN THE SHEATH TO THE DILATOR. PRODUCT HAD AN OBLONG TIP THAT CREATED A GAP BETWEEN THE SHEATH AND TRANSSEPTAL NEEDLE. DEVICE WAS NOT INSERTED INTO PATIENT. NO ADVERSE EVENT REPORTED AND NO ADDITIONAL INFORMATION IS AVAILABLE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304103 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101497. One submission often covers many models, so check the product and lot details in each record.

• Z-0800-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 10F C55 S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via
• Z-0803-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 10F C55 S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via
• Z-0794-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 8F C55 S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via
• Z-0809-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium
• Z-0793-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 8F C120 S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via
• Z-0810-2017 · Oct 5, 2016 · Terminated
  OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via
• Z-0815-2017 · Oct 5, 2016 · Terminated
  MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introduction of catheters to any of the heart chamber
• Z-0819-2017 · Oct 5, 2016 · Terminated
  MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers,
• Z-0802-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 10F C120 S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium vi
• Z-0816-2017 · Oct 5, 2016 · Terminated
  MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70 S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chamber
• Z-0813-2017 · Oct 5, 2016 · Terminated
  MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chamber
• Z-0797-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 8F C120 S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via
• Z-0817-2017 · Oct 5, 2016 · Terminated
  MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chamber
• Z-0806-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 10F C120 S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium vi
• Z-0808-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium

…and 15 more.