Arrive™ Braided Transseptal Sheath 990061-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169530591), received between Jan 30, 2017 and Jun 12, 2025 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Scratched 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARRIVE WAS NOT IN USE WHEN EVENT OCCURRED; NO ALLEGED PRODUCT ISSUE WAS REPORTED. THE EVENT OCCURRED POST-OPERATIVELY TO A CRYO ABLATION PROCEDURE; THE DOCTOR INFORMED THE REPRESENTATIVE ABOUT PERICARDITIS AFTER THE CASE. THE PATIENT EXPERIENCED CARDIAC SYMPTOMS AND COMPLICATIONS, INCLUDING PERICARDIAL EFFUSION AND PERICARDITIS. PATIENT WAS NOT UNDER GENERAL ANESTHESIA, NO PATIENT INJURY BECAUSE OF THE EVENT, AND CASE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THE EVENT LED TO AN EXTENDED HOSPITALIZATION, HOWEVER, WHEN ASKED IF A MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF A FUNCTION, IT WAS REPORTED IT WOULD NOT BE MADE AVAILABLE (LEGAL/CONFIDENTIAL REASON). THE ARRIVE WILL NOT BE RETURNED AS IT WAS DISCARDED.

  Patient problems: Pericardial Effusion; Pericarditis

  MAUDE report 22195197 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, BY HCPS, THAT IMMEDIATELY FOLLOWING A CARDIAC ABLATION PROCEDURE, FLUID WAS OBSERVED VIA ULTRASOUND, INDICATING A CARDIAC TAMPONADE. THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THE TIME. AN INFUSION WAS PERFORMED TO EXTRACT THE FLUID. THE PATIENT'S OUTCOME WAS REPORTED AS ALIVE, WITH INJURY (CARDIAC TAMPONADE). THE TAMPONADE WAS OBSERVED AFTER THE PHYSICIAN TOOK THE SHEATH AND THE BALLON OUT, SO THE PROCEDURE WAS ALREADY COMPLETED. THEY DID PERICARDIAL INFUSION TO REMOVE THE FLUID THAT WAS FOUND, AND THE PATIENT RECOVERED COMPLETELY. THE PHYSICIAN WASN'T 100% SURE BUT THEY ASSUME THAT THE INCIDENT OCCURRED DURING THE TRANSEPTAL PUNCTURE. FOR TRANSEPTAL WE USED OUR ARRIVE SHEATH. NO ISSUE WITH ARRIVE SHEATH REPORTED. THE ARRIVE SHEATH IS NOT AVAILABLE TO EVALUATE, AS THEY DISCARDED IT.

  Patient problems: Cardiac Tamponade

  MAUDE report 21988077 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT FOLLOWING A COMPLETED CRYO ABLATION PROCEDURE, THE PATIENT HAD DIFFICULTY RECOVERING FROM DEEP SEDATION. A MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED AND SHOWED AN ACUTE THROMBOEMBOLIC STROKE. THE PATIENT RECEIVED THROMBOLYSIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. CUSTOMER DISCARDED THE PRODUCT. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA. PATIENT SYMPTOMS INCLUDE NEUROLOGIC STROKE OR CEREBRAL VASCULAR ACCIDENT. THIS REPORT IS FOR ADMINISTRATIVE PURPOSES ONLY.

  Patient problems: Cardiac Tamponade

  MAUDE report 17573220 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE WHILE CROSSING THE SEPTUM WITH THE TRANSSEPTAL SHEATH, CONTRAST WAS INJECTED INTO THE LEFT ATRIUM AND THE PATIENT SUDDENLY HAD ST ELEVATION APPEAR ON THE ELECTROCARDIOGRAM (ECG) IN CONJUNCTION WITH BRADYCARDIA AND HYPOTENSION. THE DECISION TO CATHETERIZE THE PATIENT WAS MADE BUT THE ST ELEVATION RESOLVED PRE-CORONARY INJECTION. NO CORONARY ARTERY ABNORMALITY THAT COULD CAUSE A MYOCARDIAL INFARCTION WAS OBSERVED. THE OUTCOME OF THE CASE IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO ALLEGED PRODUCT ISSUES. PRODUCT WAS LOST AND WILL NOT BE RETURNED.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Myocardial Infarction

  MAUDE report 17443068 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TRANSSEPTAL ACCESS PATIENT EXPERIENCED A SMALL AMOUNT OF PERICARDIAL FLUID. NO DEVICE MALFUNCTION REPORTED. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pericardial Effusion

  MAUDE report 12300248 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SUCCESSFUL CRYO ABLATION PROCEDURE, THE PATIENT HAD LOW BLOOD PRESSURE AND BEGAN TO DECOMPENSATE. A THORACIC ECHOGRAPHY WAS PERFORMED AND A CARDIAC TAMPONADE WAS OBSERVED. SURGICAL INTERVENTION TOOK PLACE, A SMALL HOLE (PERFORATION) WAS DETECTED IN THE INTERSECTION SVC AND RA. THE TAMPONADE WAS DRAINED AND PERFORATION REPAIRED, PATIENT IS IN VERY GOOD CONDITION. THERE WAS NO ISSUE REPORTED WITH THE ARRIVE GUIDING SHEATH. NO EXTENDED HOSPITALIZATION REQUIRED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 11825641 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY PATIENT EXPERIENCED PERICARDIAL EFFUSION. NO TREATMENT REQUIRED TO TREAT THE PERICARDIAL EFFUSION. THE CASE WAS ABORTED AND PROCEDURE SCHEDULED FOR ANOTHER TIME. THERE WAS NO ISSUE WITH ARRIVE GUIDING SHEATH REPORTED. NO OTHER ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pericardial Effusion

  MAUDE report 11651550 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER CRYO ABLATION PROCEDURE PATIENT HAD LOW BLOOD PRESSURE. THE PHYSICIAN CONCLUDED THE PATIENT HAD A PERICARDIAL EFFUSION RESULTING FROM CARDIAC TAMPONADE. THE REASON FOR AND TIME OF THE TAMPONADE IS UNKNOWN. A PERICARDIOCENTESIS WAS PERFORMED, SUCCESSFULLY INCREASING THE BLOOD PRESSURE, BUT IT DID NOT STOP THE BLEEDING. THE PATIENT WAS TRANSFERRED TO CARDIAC SURGERY TO STOP THE BLEEDING AND CLOSE THE TAMPONADE; THE BLEEDING WAS STOPPED SUCCESSFULLY BUT THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MONITORING AND HEMODIALYSIS WAS PERFORMED. THE PATIENT PASSED AWAY DURING THE NIGHT. DATE OF DEATH IS (B)(6) 2019. CAUSE OF DEATH IS CARDIAC TAMPONADE LEAD TO PERICARDIAL EFFUSION. THE REASON AND THE TIME OF THE TAMPONADE IS UNKNOWN. NO ADDITIONAL INFORMATION AVAILABLE. NO PRODUCT MALFUNCTION REPORTED.

  Patient problems: Blood Loss; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 9452435 ↗
• MalfunctionMay 7, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SYSTEM DID NOT RECOGNIZE THE CATHETER. THE AUTO CONNECTION BOX AND ELECTRICAL UMBILICAL CABLE WERE REPLACED WITHOUT RESOLVE. THE BALLOON CATHETER WAS THEN REPLACED WITH RESOLVE. IT WAS FURTHER REPORTED THAT WHEN INSERTING THE DILATOR INTO THE SHEATH, THERE WAS A "CUT FRAGMENT" FROM THE SHEATH. THE SHEATH WAS REPLACED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. AS PER ADDITIONAL INFORMATION, WHEN THE PHYSICIAN TRIED TO INSERT THE DILATOR HE FOUND RESISTANCE FROM WITHIN THE SHEATH AND WHEN HE PULLED OUT THE DILATOR THE RUBBER BAND CAME OUT WITH IT. THE INCIDENT OCCURRED DURING PREPARATION. THE "CUT FRAGMENT" WASN'T NOTICED INSIDE THE PATIENT'S BODY. NO ADDITIONAL DEVICES WERE USED DURING THE PROCEDURE. NO SPECIFIC TECHNIQUE WAS USED FOR THE INSERTION. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. NO ADVERSE EVENT WAS REPORTED AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588158 ↗
• MalfunctionFeb 3, 2017Scratched Material; Scratched Material

  CUSTOMER REPORTED TRANSSEPTAL NEEDLE WAS SCRATCHING THE INSIDE OF THE DILATOR WHEN IT WAS INTRODUCED (WITH THE GUIDING TOOL INSIDE). PLASTIC PARTICLES WERE FOUND AFTER REMOVAL OF THE SHEATH. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6301930 ↗
• MalfunctionFeb 3, 2017Scratched Material; Scratched Material

  CUSTOMER REPORTED TRANSSEPTAL NEEDLE WAS SCRATCHING THE INSIDE OF THE DILATOR WHEN IT WAS INTRODUCED (WITH THE GUIDING TOOL INSIDE). PLASTIC PARTICLES WERE FOUND AFTER REMOVAL OF THE SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6301819 ↗
• MalfunctionJan 30, 2017Degraded; Degraded

  THE CUSTOMER REPORTED "IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A TRANSSEPTAL PUNCTURE WITH AN ARRIVE TRANSSEPTAL SHEATH AND A BROCKENBROUGH NEEDLE. THE USER THEN INTRODUCED A PVAC GOLD INTO THE SHEATH, BUT THE CATHETER WOULD NOT LOAD PAST 10CM. WHEN THE PHYSICIAN PULLED BACK THE CATHETER HE FOUND A PIECE OF PLASTIC COMING FROM THE DILATOR OF THE ARRIVE TRANSSEPTAL SHEATH. THE USER CHANGED THE SHEATH AND FINISHED THE PROCEDURE WITH NO PATIENT COMPLICATIONS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6285884 ↗

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-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-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-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-0801-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 10F C70 S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via
• 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-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-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-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-0798-2017 · Oct 5, 2016 · Terminated
  OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium
• 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-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-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-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
• 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-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

…and 15 more.