Venovo® VENUM16120Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741103599), received between Jul 12, 2019 and Oct 25, 2024 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (23 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 14, 2020Class IIOpen, Classified

   Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

   Z-1897-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST AN ANGIOPLASTY PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED PRESSURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531705 ↗
• MalfunctionAug 12, 2024Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY BECAME STUCK TO THE INNER CATHETER. IT WAS FURTHER REPORTED THAT THERE WAS A SLIGHT PANIC AND DISCOMFORT TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19958455 ↗
• MalfunctionJul 2, 2024Break; Premature Activation; Difficult to Advance; Break; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT COMMON FEMORAL VEIN, THE STENT ALLEGEDLY HAD RESISTANCE WHILE ADVANCING AND THE STENT ALLEGEDLY STARTED TO DEPLOY ON ITS OWN. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19654026 ↗
• MalfunctionJun 18, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE STENT ALLEGEDLY WOULD NOT FULLY EXPAND. IT WAS FURTHER REPORTED THAT THE STENT WAS ROTATED IN COUNTERCLOCKWISE AND THEN CLOCKWISE FOR ABOUT HALF A TURN AND, THEN THE STENT ALLEGEDLY GOT RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557086 ↗
• MalfunctionSep 5, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY STICKING DURING DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE CATHETER WAS PUSHED PROXIMALLY AND SLIGHTLY TWISTED IN AND THEN THE STENT WAS RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682481 ↗
• MalfunctionJul 21, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT COMMON ILIAC VEIN VIA LEFT COMMON FEMORAL ACCESS, THE DISTAL PART OF THE STENT ALLEGEDLY FAILED TO OPEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372448 ↗
• MalfunctionJul 10, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY EXTREMELY HARD TO ADVANCE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS CRIMPED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285601 ↗
• MalfunctionJun 8, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC VEIN VIA POPLITEAL VEIN, THE PROXIMAL END OF THE STENT ALLEGEDLY REMAINED STUCK TO THE CATHETER AND DID NOT FULLY EXPAND. IT WAS FURTHER REPORTED THAT AFTER SEVERAL ROTATIONS WITH THE GRIP, THE STENT FINALLY EXPANDED FROM THE CATHETER AFTER SEVERAL MINUTES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17085392 ↗
• MalfunctionMay 22, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN AND INTO THE INFERIOR VENA CAVA VIA BILATERAL GROIN ACCESS, STENT WAS ALLEGEDLY STUCK TO THE STENT CUSHION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973675 ↗
• MalfunctionMay 16, 2023Fracture; Detachment of Device or Device Component; Activation Failure; Fracture; Detachment of Device or Device Component; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC VEIN, THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON WAS USED TO POST DILATE WHICH CAUSED THE STENT TO FULLY RELEASE FROM THE CATHETER AND IT TOOK APPROXIMATELY A TOTAL OF TWENTY MINUTES FOR THE STENT TO FULLY EXPAND IN THE PATIENT. FURTHERMORE, THE PHYSICIAN REMOVED THE RETRACTING CATHETER FROM THE BODY. REPORTEDLY, THE STENT WAS ALLEGEDLY FRACTURED FROM ONE OF THE STRUTS AREA WHERE THE STENT WAS STUCK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937329 ↗
• MalfunctionMay 15, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE FOR ILIAC VEIN COMPRESSION IN RIGHT ILIAC VEIN VIA RIGHT GROIN ACCESS, THE STENT ALLEGEDLY STUCK TO THE PAD UPON DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928697 ↗
• MalfunctionMay 11, 2023Malposition of Device; Activation Failure; Malposition of Device; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN ILIAC VEIN, THE CATHETER WAS ALLEGEDLY STUCK TO THE SIDE WALL OF THE STENT. IT WAS FURTHER REPORTED THAT THE STENT WAS PULLED DOWN DURING REMOVAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910363 ↗
• MalfunctionApr 19, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY STUCK ON THE INNER CATHETER FOR THIRTY SECONDS AND THE USER HAD TWIST THE CATHETER FOR COMPLETE RELEASE FROM THE INNER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770045 ↗
• MalfunctionApr 6, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC FEMORAL ARTERY THROUGH POPLITEAL ACCESS, THE STENT WAS ALLEGEDLY STUCK ON CATHETER. IT WAS FURTHER REPORTED THAT THE STENT WAS NOT DEPLOYED AND RELEASED PROPERLY FROM THE CATHETER. REPORTEDLY, PHYSICIAN HAD TO TWIST AND PULL THE CATHETER OFF OF STENT FOR THE STENT TO RELEASE. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689918 ↗
• MalfunctionApr 6, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC FEMORAL ARTERY THROUGH POPLITEAL ACCESS, THE STENT WAS ALLEGEDLY STUCK ON CATHETER. IT WAS FURTHER REPORTED THAT THE STENT WAS NOT DEPLOYED AND RELEASED PROPERLY FROM THE CATHETER. REPORTEDLY, PHYSICIAN HAD TO TWIST AND PULL THE CATHETER OFF OF STENT FOR THE STENT TO RELEASE. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16687556 ↗
• MalfunctionMar 23, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE IN RIGHT ILIAC VEIN, THE STENT ALLEGEDLY FAILED TO FULLY DEPLOY FOR AROUND THREE MINUTES ON THE PROXIMAL END AT THE RESIN CONTROL PAD. IT WAS FURTHER REPORTED THAT THE STENT WAS RELEASED FROM THE PAD ROUGHLY THREE MINUTES AFTER THE INITIATION OF THE DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16596689 ↗
• MalfunctionMar 22, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT EXTERNAL ILIAC VIA RIGHT INTERNAL JUGULAR VEIN, THE STENT WAS ALLEGEDLY STUCK TO THE CATHETER AND ALLEGEDLY NOT OPENED FULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589177 ↗
• MalfunctionMar 4, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN SUPERIOR VENACAVA BRACHIOCEPHALIC LESION SITE VIA LEFT FEMORAL VEIN APPROACH, THE STENT WAS DEPLOYED FINE WITH NO ISSUES UNTIL THE LAST TEN PERCENT AND IT WAS ALLEGEDLY ADHERED TO THE PAD. IT WAS FURTHER REPORTED THAT WHEN STENT HANDLE WAS ROTATED, THE STENT DEPLOYED OFF FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483382 ↗
• MalfunctionJan 31, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO EXPAND AND STUCK ON THE SMALL DISTAL PORTION OF THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270198 ↗
• MalfunctionJan 5, 2023Misfire; Activation Failure; Misfire; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA FEMORAL VEIN, THE STENT WAS ALLEGEDLY PARTIALLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110282 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST STENT IMPLANT IN THE LEFT COMMON ILIAC VEIN, THE PATIENT ALLEGEDLY EXPERIENCED ALLERGIC REACTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12165071 ↗
• MalfunctionApr 8, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN RIGHT COMMON ILIAC VEIN, THE STENT ALLEGEDLY HAD AN EXPANSION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633038 ↗
• MalfunctionMar 15, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT THE DEVICE ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11482700 ↗
• MalfunctionMar 9, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PROXIMAL END OF THE STENT FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE STENT WAS COMPLETELY CAUGHT AND ROTATED THE HANDLE FOR 5 TIMES STENT GOT RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441701 ↗
• MalfunctionMar 4, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY HAD EXPANSION ISSUE AT PROXIMAL END. IT WAS FURTHER REPORTED THAT AFTER ROTATION OF THE HANDLE THE STENT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11411213 ↗