POD 400POD4-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948020337), received between Jul 1, 2022 and Jul 10, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 16, 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.

• MalfunctionJul 10, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR AURICULAR ARTERY USING A POD400 COIL AND AN ACCESS25 DELIVERY MICROCATHETER (ACCESS25). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE POD400 TO THE TARGET VESSEL USING THE ACCESS25. WHILE REPOSITIONING THE POD400, IT UNINTENTIONALLY DETACHED WITH HALF THE COIL IN THE TARGET VESSEL AND HALF INSIDE THE ACCESS25. THE PHYSICIAN THEN PUSHED THE DETACHED POD400 INTO THE TARGET VESSEL USING THE PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING A POD PACKING COIL (PACKING COIL) AND THE SAME ACCESS25. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473124 ↗
• MalfunctionNov 6, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A POD400 COIL, A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE POD400 COIL TO THE TARGET LOCATION USING THE PX SLIM. WHILE ATTEMPTING TO RETRACT THE POD400 COIL FOR REPOSITIONING, THE POD400 COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN PUSHED THE DETACHED POD400 COIL OUT OF THE PX SLIM AND INTO THE TARGET LOCATION. IT SHOULD BE NOTED THAT THERE WAS NO ALLEGED DEVICE DEFICIENCY TO THE PX SLIM. THE PROCEDURE WAS COMPLETED USING TEN ADDITIONAL COILS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080302 ↗
• MalfunctionJul 1, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT VERTEBRAL ARTERY USING A POD400 COIL, NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS IN THE TARGET LOCATION USING THE MICROCATHETER. NEXT, WHILE ADVANCING A POD400 INTO THE TARGET LOCATION USING THE MICROCATHETER, IT WAS REPORTED THAT THE PHYSICIAN PULLED BACK AFTER THE POD400 WAS PARTIALLY ADVANCED INTO THE ARTERY. CONSEQUENTLY, THE POD400 HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN ADVANCED THE CATHETER OVER THE MICROCATHETER AND DETACHED POD400 AND REMOVED THE CATHETER, MICROCATHETER AND DETACHED POD400 TOGETHER AS A UNIT. THE PHYSICIAN PERFORMED AN ANGIOGRAM AND WAS SATISFIED WITH THE PACKING DENSITY AND ENDED THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14886752 ↗