Innova™ Vascular H74939293074070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729873723), received between May 19, 2017 and Oct 5, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P140028); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2018Premature Activation; Failure to Advance; Difficult to Advance; Premature Activation; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. ACCESS WAS GAINED VIA THE LEFT FEMORAL, WITH A 6 (B)(6) SHEATH, FOR AN IN STENT RESTENOSIS TREATMENT PROCEDURE FROM THE SUPERFICIAL FEMORAL ARTERY (SFA) TO THE PROXIMAL POPLITEAL. THE PHYSICIAN ATTEMPTED TO ADVANCE 2 SEPARATE INNOVA STENTS OVER A NON BSC GUIDEWIRE BUT THE STENTS STARTED TO DEPLOY BEFORE ENTERING THE HUB OF THE SHEATH FROM THE FORCE REQUIRED TO ADVANCE THE STENT DELIVERY SYSTEM OVER THE NON BSC GUIDEIRE. NEITHER STENT ENTERED THE SHEATH OR THE BODY OF THE PATIENT. THE PHYSICIAN WAS ABLE TO IMPLANT A NON BSC STENT AND POST-DILATED WITH A POBA BALLOON. THE CASE WAS COMPLETED WITH A GOOD OUTCOME AND THE PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7938171 ↗
• InjuryMay 19, 2017Activation Failure; Activation Failure

  SAME CASE AS MDR ID:2134265-2017-04810. IT WAS REPORTED TWO STENTS FAILED TO EXPAND. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. USING A CONTRALATERAL APPROACH, THE PHYSICIAN ADVANCED A 7 X 60 X 130 INNOVA STENT AND DEPLOYED BUT FAILED TO EXPAND. A SECOND 7 X 40 X 75 INNOVA STENT WAS THEN ADVANCED AND DEPLOYED BUT ALSO FAILED TO EXPAND. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE BY POST DILATING THE STENTS WITH BALLOON ANGIOPLASTY. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6579051 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140028. One submission often covers many models, so check the product and lot details in each record.

• Z-0686-2018 · Nov 6, 2017 · Open, Classified
  Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated
• Z-0685-2018 · Nov 6, 2017 · Open, Classified
  Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated t