Arrive™ Braided Transseptal Sheath 990061-055Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169530584), received between Nov 16, 2016 and Dec 14, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE PATIENT AFTER THE TRANSEPTAL PUNCTURE WAS COMPLETED. IT WAS DIFFICULT MANEUVERING THE GUIDE FOR THE SHEATH AND THE INTRODUCER OF THE SHEATH PERFORATED THROUGH THE AORTA. THE PROCEDURE WAS ABORTED. THE PATIENTS HOSPITALIZATION WAS EXTENDED FOR THE PATIENT TO UNDERGO HEART SURGERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FOLLOWING A CONTRAST BY THE INTRODUCER FOR DIFFICULTY IN MANEUVERING THE GUIDE, VISUALIZATION OF THE INTRODUCER IN THE AORTA. PROCEDURE IMMEDIATELY BLOCKED. PATIENT WITH STABLE VITAL SIGNS. INTRODUCER AND GUIDE LEFT IN PLACE AND SECURED. THE PATIENT WAS TRANSPORTED BY HELICOPTER TO THE HEART SURGERY OF THE (B)(6) HOSPITAL. THE PHYSICIAN WAS PERFORMING TRANSSEPTAL WITH NEEDLE WHEN ISSUE OCCURRED. THE INTRODUCER WAS EXTRACTED IN THE CARDIOSURGERY LAB. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN GOOD CONDITION. NO ALLEGED PRODUCT USE.

  Patient problems: Perforation

  MAUDE report 13005572 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6)2020 ADDITIONAL INFORMATION REPORTED THE PATIENT UNDERWENT CRYOABLATION OF THE PULMONARY VEINS FOR THE TREATMENT OF ATRIAL FIBRILLATION, REFRACTORY TO MEDICAL THERAPY. WHEN PLACING THE DEVICE ON THE SEPTAL PULMONARY VEINS, THE SAME IS DISLOCATED IN THE RIGHT ATRIUM. IT WAS THEREFORE REPOSITIONED IN LEFT ATRIUM, THROUGH THE PREVIOUS TRANSSEPTAL PUNCTURE SITE BY MEANS OF A GUIDE. FOLLOWING THIS MANEUVER IT WAS DETERMINED CARDIAC TAMPONADE, RESOLVED WITH PERCUTANEOUS DRAINAGE. THE PATIENT WAS THEN TRANSFERRED TO INTENSIVE CARE; HEMODYNAMICS WAS RESTORED FOLLOWING PERCUTANEOUS DRAINAGE, AND RESPIRATORY ARREST TREATED WITH MECHANIC VENTILATION. FOR 22 DAYS AFTER PROCEDURE, THE PATIENT REMAINED IN AN IRREVERSIBLE COMA AND DIED ON(B)(6)2020. THE SEQUENCE OF EVENTS WAS ATTRIBUTED TO THE PATIENT'S FRAGILITY AND COMORBIDITIES.

  Patient problems: Cardiac Tamponade; Chronic Obstructive Pulmonary Disease (COPD); Coma; Death; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 10298618 ↗
• MalfunctionDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED AT THE BEGINNING OF THE RADIOFREQUENCY PROCEDURE THE PHYSICIAN WASHED THE ARRIVE AND THE HEMOSTATIC VALVE HAS BEEN DETACHED FROM THE DEVICE, SO THE PHYSICIAN REPLACED IT WITH A NEW ONE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9452445 ↗
• MalfunctionDec 29, 2016Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material

  LOCATION: (B)(6). PRODUCT INVOLVED IN THE EVENT: ARRIVE GUIDING SHEATH 10FR SHEATH MODEL/REF 990061-055 (LOT:C1- 12713) AND A MEDTRONIC BROCKENBROUGH CURVED TRANSEPTAL NEEDLE MODEL/REF EP003994S( LOT: 211439989). EVENT DESCRIPTION: PRIOR TO THE PROCEDURE, PHYSICIAN PERFORMED A DEMO RUN WITH THE SHEATH AND MEDTRONIC CURVED TRANSSEPTAL NEEDLE. AFTER INSERTION OF THE NEEDLE INTO THE DILATOR, HE FLUSHED THE DILATOR AND SMALL FRAGMENT FROM THE INNER LUMEN OF THE DILATOR WERE SEEN FLUSHED OUT. THE PHYSICIAN THEN PROCEEDED TO USE ANOTHER SHEATH WITH A ST. JUDE MEDICAL BRK NEEDLE, PERFORMED ANOTHER DEMO RUN AND NO FRAGMENTS WERE FLUSHED OUT. THE PHYSICIAN THEN PROCEEDED TO PERFORM THE PROCEDURE WITH THE ARRIVE SHEATH AND THE DEVICE WORKED FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6212716 ↗
• MalfunctionNov 16, 2016Device Contamination with Chemical or Other Material; Scratched Material; Nonstandard Device; Device Operates Differently Than Expected; Device Contamination with Chemical or Other Material; Scratched Material

  IT WAS REPORTED THAT FOLLOWING TRANSSEPTAL PUNCTURE, THE BROCKENBROUGH NEEDLE AND ARRIVE SHEATH WERE REMOVED AND FLUSHED ON THE TABLE. A PIECE OF LINING FROM THE SHEATH WAS FLUSHED OUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6107295 ↗

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-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-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-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-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-0795-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 8F C70 S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via
• Z-0791-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 8F C70 S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via
• 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-0807-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atriu
• Z-0818-2017 · 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 chambers
• Z-0814-2017 · Oct 5, 2016 · Terminated
  MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120 S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of catheters to any of the heart chambe
• 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-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
• Z-0792-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 8F C90 S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via
• Z-0812-2017 · Oct 5, 2016 · Terminated
  MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70 S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chamb
• Z-0790-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 8F C55 S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via

…and 15 more.