ENVOY 670-256-00BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704031703), received between Nov 14, 2025 and Nov 14, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR RECEIVED 3 BOXES THAT APPEARED TO HAVE BEEN OPENED, ENVOY 6F, XB MPC 100CM (67025600B / 31675240). A PERSON FROM THE QUALITY TEAM WENT TO INSPECT THE PRODUCTS INSIDE. THE PRODUCTS AND THEIR INTERNAL PACKAGING DO NOT APPEAR TO BE DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 10/21/2025 STATING THAT THE PRODUCTS INSIDE THE BOXES WERE INTACT, AND CONFIRMING THERE WAS DAMAGE TO THE SHIPPING BOX, THE SHIPPING CARTON WAS TORN RIGHT AT THE 3 OPEN BOXES, AS IF SOMEONE HAD OPENED THE CARTON TO SEE WHAT WAS INSIDE. UNFORTUNATELY, THEIR LOGISTICS DEPARTMENT DISCARDED THE SHIPPING CARTON BEFORE TAKING PICTURES OF THE OPEN BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554596 ↗
• MalfunctionNov 14, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR RECEIVED 3 BOXES THAT APPEARED TO HAVE BEEN OPENED, ENVOY 6F, XB MPC 100CM (67025600B / 31675240). A PERSON FROM THE QUALITY TEAM WENT TO INSPECT THE PRODUCTS INSIDE. THE PRODUCTS AND THEIR INTERNAL PACKAGING DO NOT APPEAR TO BE DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 10/21/2025 STATING THAT THE PRODUCTS INSIDE THE BOXES WERE INTACT, AND CONFIRMING THERE WAS DAMAGE TO THE SHIPPING BOX, THE SHIPPING CARTON WAS TORN RIGHT AT THE 3 OPEN BOXES, AS IF SOMEONE HAD OPENED THE CARTON TO SEE WHAT WAS INSIDE. UNFORTUNATELY, THEIR LOGISTICS DEPARTMENT DISCARDED THE SHIPPING CARTON BEFORE TAKING PICTURES OF THE OPEN BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554557 ↗
• MalfunctionNov 14, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR RECEIVED 3 BOXES THAT APPEARED TO HAVE BEEN OPENED, ENVOY 6F, XB MPC 100CM (67025600B / 31675240). A PERSON FROM THE QUALITY TEAM WENT TO INSPECT THE PRODUCTS INSIDE. THE PRODUCTS AND THEIR INTERNAL PACKAGING DO NOT APPEAR TO BE DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 10/21/2025 STATING THAT THE PRODUCTS INSIDE THE BOXES WERE INTACT, AND CONFIRMING THERE WAS DAMAGE TO THE SHIPPING BOX, THE SHIPPING CARTON WAS TORN RIGHT AT THE 3 OPEN BOXES, AS IF SOMEONE HAD OPENED THE CARTON TO SEE WHAT WAS INSIDE. UNFORTUNATELY, THEIR LOGISTICS DEPARTMENT DISCARDED THE SHIPPING CARTON BEFORE TAKING PICTURES OF THE OPEN BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554501 ↗