ENVOY 671-258-95DRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10878528000652), received between Mar 20, 2018 and Apr 25, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Crack” (14 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Crack; Crack

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, ¿PART NEXT TO HUB CRACKED¿ OF AN ENVOY DA, 6F, 95CM, MPD GUIDE CATHETER (67125895D, 31253180). NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910020 ↗
• MalfunctionMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE HUB OF THE ENVOY DA, 6F, 95CM, MPD (67125895D / 31253180) WAS KINKED AND THERE WAS LEAKAGE OF SALINE. THE PHYSICIAN REPLACED THE DEVICE WITH A ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 23-JAN-2025, THE COMPLAINT PRODUCT WAS RECEIVED IN THE PRODUCT ANALYSIS LAB. THERE WERE TWO ENVOY DA, 6F, 95CM, MPD (67125895D) FROM THE SAME LOT NUMBER (31253180). ONE OF THE DEVICES BELONG TO THE COMPLAINT AND WAS INVESTIGATED. ON 04-MAR-2025, AN EMAIL RESPONSE WAS RECEIVED FROM THE SOUTH KOREA BQ TEAM RELATED TO THE EXTRA PRODUCT: "I¿VE CONFIRMED 1 COMPLAINT SAMPLE IS RIGHT AND THE ADDITIONAL ONE IS MISTAKENLY SHIPPED WITH A COMPLAINT SAMPLE AFTER INTERVIEWING SALE REF." BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 12-MAR-2025, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586979 ↗
• MalfunctionDec 9, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE HUB OF THE ENVOY DA, 6F, 95CM, MPD (67125895D / 31272794) WAS CRACKED AND THERE WAS A HUB LEAKAGE. THE PHYSICIAN REPLACED THE DEVICE WITH A ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20884576 ↗
• MalfunctionDec 9, 2024Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE HUB OF THE ENVOY DA, 6F, 95CM, MPD (67125895D), THE LOT NUMBER REPORTED WAS 31253108 (THIS LOT NUMBER IS PENDING VERIFICATION). WAS KINKED AND THERE WAS LEAKAGE OF SALINE. THE PHYSICIAN REPLACED THE DEVICE WITH A ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20884200 ↗
• MalfunctionOct 16, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ¿WHEN THE PHYSICIAN AND TECHNICIANS PREPARED THE CATHETER, THEY FOUND LEAKAGE OF SALINE FROM THE HUB AFTER CONNECTING TO THE RHV. ¿THEY USED SAME LIKE PRODUCT AND THE PROCEDURE [WAS] SUCCESSFUL, BUT THEY EXPERIENCE THE SAME LEAKAGE OVER AND OVER IN A ROW. SO THEY REQUESTED THE INVESTIGATION ON THE PRODUCTS IN THIS LOT (31253180).¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467162 ↗
• MalfunctionOct 16, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ¿WHEN THE PHYSICIAN AND TECHNICIANS PREPARED THE CATHETER, THEY FOUND LEAKAGE OF SALINE FROM THE HUB AFTER CONNECTING TO THE RHV. ¿THEY USED SAME LIKE PRODUCT AND THE PROCEDURE [WAS] SUCCESSFUL, BUT THEY EXPERIENCE THE SAME LEAKAGE OVER AND OVER IN A ROW. SO THEY REQUESTED THE INVESTIGATION ON THE PRODUCTS IN THIS LOT (31253180).¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466921 ↗
• MalfunctionOct 16, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ¿WHEN THE PHYSICIAN AND TECHNICIANS PREPARED THE CATHETER, THEY FOUND LEAKAGE OF SALINE FROM THE HUB AFTER CONNECTING TO THE RHV. ¿THEY USED SAME LIKE PRODUCT AND THE PROCEDURE [WAS] SUCCESSFUL, BUT THEY EXPERIENCE THE SAME LEAKAGE OVER AND OVER IN A ROW. SO THEY REQUESTED THE INVESTIGATION ON THE PRODUCTS IN THIS LOT (31253180).¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466190 ↗
• MalfunctionOct 16, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ¿WHEN THE PHYSICIAN AND TECHNICIANS PREPARED THE CATHETER, THEY FOUND LEAKAGE OF SALINE FROM THE HUB AFTER CONNECTING TO THE RHV. ¿THEY USED SAME AS PRODUCT AND THE PROCEDURE [WAS] SUCCESSFUL, BUT THEY EXPERIENCE THE SAME LEAKAGE OVER AND OVER IN A ROW. SO, THEY REQUESTED THE INVESTIGATION ON THE PRODUCTS IN THIS LOT (31253180).¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466177 ↗
• MalfunctionOct 16, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ¿WHEN THE PHYSICIAN AND TECHNICIANS PREPARED THE CATHETER, THEY FOUND LEAKAGE OF SALINE FROM THE HUB AFTER CONNECTING TO THE RHV. ¿THEY USED SAME LIKE PRODUCT AND THE PROCEDURE [WAS] SUCCESSFUL, BUT THEY EXPERIENCE THE SAME LEAKAGE OVER AND OVER IN A ROW. SO THEY REQUESTED THE INVESTIGATION ON THE PRODUCTS IN THIS LOT (31253180).¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465514 ↗
• MalfunctionOct 16, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ¿WHEN THE PHYSICIAN AND TECHNICIANS PREPARED THE CATHETER, THEY FOUND LEAKAGE OF SALINE FROM THE HUB AFTER CONNECTING TO THE RHV. ¿ THEY USED SAME LIKE PRODUCT AND THE PROCEDURE [WAS] SUCCESSFUL, BUT THEY EXPERIENCE THE SAME LEAKAGE OVER AND OVER IN A ROW. SO THEY REQUESTED THE INVESTIGATION ON THE PRODUCTS IN THIS LOT (31253180).¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465324 ↗
• MalfunctionSep 23, 2024Crack; Crack

  AS REPORTED BY THE FIELD, THE SIDE HUB OF AN ENVOY DA, 6F, 95CM, MPD CATHETER (67125895D, LOT UNKNOWN) WAS SPLIT. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279419 ↗
• MalfunctionAug 15, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, WHEN THE PHYSICIAN AND TECHNICIANS PREPARED AN ENVOY DA, 6F, 95CM, MPD CATHETERS (67125895D, 30939431) AND AN ENVOY DA, 6F, 95CM, MPD CATHETER (67125895D, 31253180), THEY FOUND LEAKAGE OF SALINE FROM THE HUB AFTER CONNECTING RHV. THEY USED THE SAME LIKE PRODUCT AND THE PROCEDURE WENT SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991495 ↗
• MalfunctionAug 15, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, WHEN THE PHYSICIAN AND TECHNICIANS PREPARED AN ENVOY DA, 6F, 95CM, MPD CATHETERS (67125895D, 30939431) AND AN ENVOY DA, 6F, 95CM, MPD CATHETER (67125895D, 31253180), THEY FOUND LEAKAGE OF SALINE FROM THE HUB AFTER CONNECTING RHV. THEY USED THE SAME LIKE PRODUCT AND THE PROCEDURE WENT SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991478 ↗
• MalfunctionAug 15, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, WHEN THE PHYSICIAN AND TECHNICIANS PREPARED TWO ENVOY DA, 6F, 95CM, MPD CATHETERS (67125895D, 31253180), THEY FOUND LEAKAGE OF SALINE FROM THE HUB AFTER CONNECTING RHV. THEY USED THE SAME LIKE PRODUCT AND THE PROCEDURE WENT SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991258 ↗
• MalfunctionAug 15, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, WHEN THE PHYSICIAN AND TECHNICIANS PREPARED TWO ENVOY DA, 6F, 95CM, MPD CATHETERS (67125895D, 31253180), THEY FOUND LEAKAGE OF SALINE FROM THE HUB AFTER CONNECTING RHV. THEY USED THE SAME LIKE PRODUCT AND THE PROCEDURE WENT SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991233 ↗
• MalfunctionFeb 26, 2024Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED BY THE FIELD, THERE WERE HOLES AT THE POINT OF 15CM FROM THE HUB OF AN ENVOY DA, 6F, 95CM, MPD CATHETER (67125895D, 31054567). THE PHYSICIAN USED THE SAME LIKE PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778219 ↗
• MalfunctionMar 17, 2020Crack; Crack

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE TIP OF THE 6F, 95CM, MPD ENVOY DA GUIDING CATHETER (67125895D / E11307) WAS CRACKED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844603 ↗
• MalfunctionMar 20, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE DISTAL TIP OF THE 6F ENVOY DA 95 CM GUIDING CATHETER DISTAL ACCESS (67125895D/ E11431) WAS NOTED TO BE KINKED. THE INTEGRITY OF THE INNER STERILE POUCH WAS COMPROMISED. THE PRODUCT WAS REPLACED WITH NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. THE KINK WAS NOT OBSERVED BEFORE THE CATHETER WAS REMOVED FROM ITS PACKAGING. THE KINK DID NOT OCCUR DURING PREPARATION/HANDLING OF THE PRODUCT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL NOTED ABOUT THE PRODUCT PACKAGING (CLARIFICATION WAS REQUESTED). FORCE WAS NOT REQUIRED WHEN HANDLING THE PRODUCT. THE INTENDED PROCEDURE WAS A COIL EMBOLIZATION. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7356485 ↗