Lotus™ Introducer Set H749NTR180Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05391526210109), received between Apr 9, 2018 and Aug 20, 2020 — classified as 2 deaths, 6 injuries.

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

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2020Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING COMPLAINT EVENT DESCRIPTION WAS RECEIVED AT (B)(6) MEDICAL; EVENT DESCRIPTION: PRODUCT NAME: LOTUS. REFERENCE: LIS-S, LOT NUMBER: 0000007302, DATE OF KNOWLEDGE OF THE CLAIM BY COMPLAINANT: 7/20/20. EVENT INFORMATION: AT THE TIME OF IMPLANTATION, THE RIGHT FEMORAL ACCESS WAS CONSIDERED THE MOST SUITABLE. ONCE THE DISSECTION WAS DONE, AN ATTEMPT WAS MADE TO UPLOAD THE LOTUS INTRODUCER BUT WAS UNSUCCESSFUL. THE ARTERY HAD TO BE REPAIRED BECAUSE WHEN THE INTRODUCER WAS REMOVED, IT WAS DAMAGED. IT IS DECIDED TO GO ON THE LEFT SIDE. AFTER DISSECTION AN ATTEMPT IS MADE TO CLIMB THE LOTUS. FAILING TO DO SO, SMALLER DILATORS ARE USED TO MAKE WAY. A 14 FR AND 18 FR INTRODUCER FROM MEDTRONIC IS USED. WHEN THE LOTUS IS STILL UNABLE TO ASCEND, AN ATP IS PERFORMED WITH 7 AND 9 MM BALLS. WHEN CONTINUING WITHOUT THE POSSIBILITY OF ACCESSING, A STENT WAS PLACED WITH THE INTENTION OF MAINTAINING THE DIAMETER OF THE ARTERY THAT HAD BEEN ABLE TO EXPAND, WHEN ATTEMPTING TO RAISE THE LOTUS, THE ARTERY RUPTURED AND CONSEQUENTLY 2 LINED STENTS. ONCE THE ARTERY IS REPAIRED, THE PROCEDURE IS TERMINATED. IT IS IMPORTANT TO NOTE THAT FROM THE TIME THE OFFICIAL REPORT WAS RECEIVED (WHICH RECOMMEN

  Patient problems: Perforation of Vessels

  MAUDE report 10430160 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: INITIAL COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: "EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT:. IMPLANTER AND PROCTOR NOTED THAT LIS S INTRODUCER WITH DILATOR HAD DIFFICULTLY ENTERING RIGHT FEMORAL PUNCTURE SITE. AS THE SKIN WAS NOT NICKED AT THE PUNCTURE, THE RESISTANCE COULD BE DUE TO THAT. PROCTOR ADVISED SLOW INTRODUCTION OF THE SHEATH MORE CO-AXIAL TO THE ARTERY. THE 1ST IMPLANTER CONTINUED WITH THE PROCEDURE WHEN THE SHEATH MANAGED TO FULLY ENTER THE ARTERY SUCCESSFULLY. THE ACCURATE NEO TAVI VALVE WAS DEPLOYED SUCCESSFULLY WITH NO ISSUES AND REMOVAL OF THE DELIVERY SYSTEM WAS PERFORMED. HOWEVER, DURING REMOVAL OF THE INTRODUCER, PATIENT BLOOD PRESSURE SUDDENLY DROPPED. TEE WAS USED TO CHECK IF ANYTHING WAS WRONG WITH VALVE AND IF THERE WAS PERICARDIAL EFFUSION. NO ISSUE WITH THE VALVE OR PERICARDIAL EFFUSION SEEN. UPON FLUORO ON THE PERIPHERAL, DISSECTION DISCOVERED 4CM ABOVE THE PUNCTURE SITE. BALLOONING DONE TO COVER THE DISSECTION FOR A WHILE UNTIL THE COVERED STENT GRAFT ARRIVED. COVERED STENT GRAFT BEGRAFT IMPLANTED SUCCESSFULLY. ROOT CAUSE OF DISSECTION UNCLEAR BECAUSE FLUOR

  Patient problems: Vascular Dissection

  MAUDE report 8653481 ↗
• DeathApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: 'INITIAL COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: "IN A FEMORAL LIMIT WITH A MINIMUM DIAMETER OF 5.8 WITHOUT CALCIUM LOTUS-S IS USED SINCE THE DISTRIBUTOR HAD NOT SENT ISLEEVE. RESISTANCE TO THE LEVEL OF THE COMMON ILIAC IS NOTED AND, AS IT CANNOT PROGRESS, THE PROCEDURE IS CONTINUED WITH EDWARDS E-SHEATH. THE VALVE IS SUCCESSFULLY PLACED AND, AFTER THE INTRODUCER IS REMOVED, A PRESSURE DROP OCCURS. CPR, ECO AND ANGIOGRAPHY MANEUVERS ARE PERFORMED. IT SEEMS THAT A BREAK IS SEEN AT THE LEVEL OF THE RIGHT COMMON ILIAC. THE CPR MANEUVERS ARE CONTINUED FOR HALF AN HOUR BUT PRESSURE CAN NOT BE RESTORED AND THE PATIENT DIES. WHERE DID THE PROBLEM OCCUR? INSIDE THE PATIENT IT WAS AN IMPLANT OF ACURATE S LOT NO.SPA332354, THE VALVE WAS WELL PLACED."

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 8508864 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem

  INITIAL COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL ON 22-DEC-2018 IS AS FOLLOWS: "AT THE END OF THE TAVI PROCEDURE BY LEFT AXILLARY ACCESS, A DISSECTION OF THE SUBCLAVIAN ARTERY WAS OBSERVED INVOLVING THE LEFT MAMMARY ARTERY (DA BYPASS). IMPELLA CP DEVICE IS IMPLANTED BY LEFT FEMORAL ACCESS. ANGIOPLASTY WAS PERFORMED ON ARTEMIS LEFT BREAST AND ON THE LEFT SUBCLAVIAN ARTERY. IMPELLA IS WITHDRAWN. AT THE END OF THE PROCEDURE, THE PATIENT IS STABLE AND CONSCIOUS. WHERE DID THE PROBLEM OCCUR? INSIDE THE PATIENT." ADDITIONAL CLARIFICATION WAS RECEIVED ON 21-JAN-2018 (REPORTABLE AWARE DATE) CONFIRMING THAT THE LOTUS DEVICE MAY HAVE CONTRIBUTED TO THE REPORTED DISSECTION AS FOLLOWS; 'THERE WERE NO ISSUES NOTED WITH THE ACURATE VALVE IMPLANT. THERE WERE NO ISSUES NOTED WHEN ADVANCING THE DELIVERY SYSTEM. THE ACURATE NEO VALVE/ DELIVERY SYSTEM WERE ONLY MENTIONED BY PHYSICIANS TO THIS COMPLIANT AS POSSIBLE CAUSE OF COMPLICATION. THE PHYSICIANS THINK THAT THE ISSUE COULD BE MORE RELATED TO THE LOTUS INTRODUCER SHEATH WHICH WAS INTRODUCED DEEP IN THE SUBCLAVIAN'.

  Patient problems: Vascular Dissection

  MAUDE report 8304120 ↗
• DeathNov 30, 2018Physical Resistance/Sticking

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: "THERE WERE NO INCIDENTS WITH THE RISE AND DEPLOYMENT OF THE ACURATE NEO TAVI. IT WAS 'ADECUATELY' POSITIONED WITH A MILD LEAK. UNTIL THEN, THE 'PHYSICIANS WAS' SATISFIED WITH THE PROCEDURE. WHEN THE LOTUS INTRODUCER WAS BEING REMOVED, THE SECOND OPERATOR (PHYSICIAN) FELT THAT THE PASSING THROUGH THE ABDOMINAL AORTA TOWARDS THE ILIAC ARTERY WAS TIGHT AND WITH GREATER PRESSURE HE PULLED THE INTRODUCER. THE BLOOD INCREASED INSIDE THE ACCESS, PRODUCING A HEMORRHAGE. IT WAS CONTROLLED, BUT BLOOD PRESSURE REMAINED LOW. WHEN PERFORMING AN ECO, THEY VIEW A LOT OF BLOOD COLLECTION AT THE HEIGHT OF THE ABDOMINAL AORTA. THERE IS NO MORE INFORMATION FROM THAT MOMENT. VASCULAR SURGERY TEAM ENTERED INTO CATH LAB, BUT IT WAS NOT POSSIBLE TO REPAIR THE DISSECTION. THE PATIENT DIED."

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 8120710 ↗
• InjuryOct 10, 2018Failure to Advance; Device-Device Incompatibility; Failure to Advance; Device-Device Incompatibility

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: "IT WAS REPORTED THAT: PATIENT HAD VERY SMALL VESSELS WITH A STENT IN THE LEFT AND RIGHT ILIAC. ACCESS OVER THE RIGHT SIDE. PREDILATATION WITH AN 8 AND A 9MM BALLOON TO CROSS THE VESSEL WITH THE BSCI SHEATH. SHEATH STUCK AT THE STENT, SO WE SWITCHED TO AN ESHEATH. WITH THE ESHEATH, THEY CROSSED THE STENT AND IMPLANTED THE VALVE. AFTER THE ESHEATH REMOVAL, THE BLOOD PRESSURE DROPPED. WITH AN ANGIO THE CARDIOLOGIST RECOGNISED THEN A RUPTURED ILIAC. THE DIAGNOSED RUPTURE WAS THEN TREATED SURGICALLY. FCE PRESENT FOR IMPLANT? YES. PROCTOR PRESENT FOR IMPLANT? YES. INDEPENDENT SITE? YES. ASSOCIATED WITH LABELED USE? NO. IF NO, EXPLAIN: USE WAS UNDER RECOMMENDED MINIMUM DIAMETER (5.1MIN./6.1MAX.). ACTION TAKEN TO RESOLVE: SURGERY. WAS THERE ANY CENTRAL OR PVL POST PROCEDURE? NO. SELECT INFORMATION THAT CAN BE FORWARDED TO BSC:CINE. WAS BAV PERFORMED? YES. WAS THE ANATOMY TORTUOUS? NO. ACCESS SITE TRANS FEMORAL LEFT WAS THERE ANY CENTRAL OR PVL POST PROCEDURE? NO. ANNULUS DIAMETER:20.6MM. WHAT WAS THE SEVERITY OF THE LEAK? NO LEAK REPORTED."

  Patient problems: Perforation of Vessels

  MAUDE report 7952258 ↗
• InjuryAug 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: "THE PROBLEM OCCURRED AFTER INSERTION OF THE LOTUS SHEATH, THE DOCTOR DID NOT FLUSH THE SIDE PORT, NOR DID HE HAVE INSTANT BACK BLEED. THE SIDE PORTS SAT IN THE DRAPES WHERE POOLING OF BLOOD WAS LATER FOUND. THE PATIENT BECAME UNSTABLE AND THE BLOOD LOSS WAS DISCOVERED. TWO UNITS OF BLOOD WHERE GIVEN. THE PATIENT RECOVERED FROM THIS EPISODE FULLY WITHOUT ANY LASTING DETRIMENTAL EFFECTS. PHYSICIAN ASSESSMENT OF THE RELATIONSHIP OF THE EVENT TO THE DEVICE: UNRELATED. MY UNDERSTANDING OF THE INFORMATION WE HAVE CURRENTLY IS THE EVENT IS RELATED TO THE DEVICE NOT GETTING FLUSHED AND NOT NECESSARILY A MALFUNCTION OF THE DEVICE. OTHER POSSIBLE CONTRIBUTING FACTORS TO THE EVENT: THE DOCTOR FORGOT TO FLUSH THE SIDE PORT AND DID NOT IMMEDIATELY OBSERVED BLEEDING FROM THE SIDE PORT AFTER THE LOTUS SHEATH WAS INSERTED".

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7811267 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL COMPLAINT DESCRIPTION WAS RECEIVED AT CREGANNA MEDICAL ON 12-MAR-2018 AS FOLLOWS: 'PROBLEM DURING THE INSERTION OF THE TRANSGLIDE INTRODUCER SHEATH (B)(4) BECAUSE THE DILATOR DIDN'T ADVANCE IN THE MESH SO A SECOND ATTEMPT WITH LIS-S (426577) WAS SUCCESSFULLY COMPLETED. AT THIS POINT THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT AFTER THE INTRODUCER REMOVAL A THROMBUS WAS NOTICED AT LEVEL OF EXTERNAL ILIAC THAT WAS REMOVED SURGICALLY.' ADDITIONAL INFORMATION WAS ON THE COMPLAINT NOTIFICATION FORM AS FOLLOWS; 'INDICATION OF PROCEDURE :AORTIC VALVE STENOSIS. WAS IVUS USED? NO. WAS A GENERATOR INVOLVED? NO. WAS THE PROBLEM ASSOCIATED WITH LABELED USE? YES. ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: SURGERY: VASCULAR SURGERY INTERVENTION TO REMOVE THE THROMBUS. EVENT RESOLVED? YES. PHYSICIAN ASSESSMENT OF THE RELATIONSHIP OF THE EVENT TO THE DEVICE: RELATED. PLEASE CHECK ALL THOSE THAT CAN BE FORWARDED TO BSC: PROCEDURE NOTES.'

  Patient problems: Thrombus

  MAUDE report 7406093 ↗