Innova™ Vascular H74939293071830Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729874140), received between Nov 17, 2016 and Nov 7, 2017 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2017Fracture; Difficult to Remove; Activation, Positioning or Separation Problem; Fracture; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT, STENT FRACTURE AND STENT WITHDRAWAL DIFFICULTY OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING PRE-DILATION WITH A COYOTE BALLOON CATHETER, A 7 X 180 X 130 INNOVA¿ STENT WAS ADVANCED CONTRALATERAL OVER A .035 NON-BSC GUIDEWIRE AND STENT DEPLOYMENT WAS INITIATED. THE STENT WAS DEPLOYED ABOUT 2CM USING THE THUMBWHEEL, THEN IT STOPPED RELEASING AND THE THUMBWHEEL MOVED FREELY. THE PULL GRIP WAS ATTEMPTED TO RELEASE THE STENT, BUT THIS FAILED. THE INNOVA DELIVERY SYSTEM WAS SLIGHTLY PUSHED AND PULLED AND PULLED BACK TOWARDS THE RIGHT EXTERNAL ILIAC ARTERY (EIA). WHEN THE DEVICE CAME INTO CONTACT WITH THE ACCESS SITE, THE STENT WAS NOT ABLE TO BE PULLED INSIDE THE SHEATH. THE DELIVERY SYSTEM WAS PULLED AND THE STENT FRACTURED AND DETACHED IN THE DISTAL LEFT EIA. THE SHEATH WAS REPLACED WITH ANGIOSEAL AND FORCEPS WERE USED TO CAPTURE THE FRACTURED STENT AND PULL IT NEAR TO THE ACCESS SITE. A CUT DOWN WAS THEN PERFORMED ON THE PATIENT AND THE FRACTURED STENT WAS REMOVED. THE PROCEDURE WAS ABORTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7007374 ↗
• MalfunctionOct 19, 2017Stretched; Activation, Positioning or Separation Problem; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT AND STENT ELONGATION OCCURRED. THE 100% STENOSED, FOCAL TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING PRE-DILATION, A 6 X 180 INNOVA¿ STENT WAS ADVANCED CONTRALATERAL OVER A 300CM GUIDEWIRE AND THE STENT WAS DEPLOYED IN THE DISTAL SFA. A 7 X 180 X 130 INNOVA¿ WAS THEN ADVANCED TO BE PLACED PROXIMAL TO THE PREVIOUS INNOVA. DURING STENT DEPLOYMENT, THE DELIVERY SYSTEM BECAME HARD AND DIFFICULT TO DEPLOY AFTER 3 TO 4CM OF THE STENT WAS DEPLOYED. THE PHYSICIAN ATTEMPTED TO FORCIBLY DEPLOY THE STENT BUT THE STENT WAS NOT ABLE TO DEPLOY. THE PHYSICIAN PULLED BACK ON THE DELIVERY SYSTEM ALLOWING THE STENT TO DEPLOY. THE STENT WAS STRETCHED A FEW CENTIMETERS ON THE PROXIMAL PORTION. THE STENT WAS POST-DILATED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6963434 ↗
• MalfunctionAug 30, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT OCCURRED. A 7X180X130 INNOVA¿ STENT WAS SELECTED IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TO TREAT THE MODERATELY TORTUOUS CHRONICALLY TOTAL OCCLUDED (THROMBOTIC) LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A NON BSC GUIDEWIRE PASSED THROUGH THE LESION AND A PARACHUTE DEVICE WAS PLACED DUE TO THE THROMBOTIC LESION. THE LESION WAS PRE-DILATED WITH A COYOTE ES2MM-40MM BALLOON CATHETER. THE INNOVA¿ STENT WAS ADVANCED VIA A CONTRALATERAL APPROACH AND THE DEPLOYMENT WAS INITIATED INTO THE PARACHUTE AND DEPLOYMENT STOPPED AT 3.4CM OF DEPLOYMENT. THE PULL GRIP WAS THEN PULLED AND TENSION WAS APPLIED TO THE STENT DELIVERY SYSTEM AND THE INNOVA¿ STENT GRADUALLY STARTED TO DEPLOY. THE STENT DELIVERY SYSTEM AND THE PARACHUTE WERE REMOVED TOGETHER AND WERE REPLACED WITH A NON BSC GUIDEWIRE. ANOTHER 7X180X130 INNOVA¿ STENT WAS THEN PLACED ON THE PROXIMAL SIDE OF THE INITIAL 7X180X130 INNOVA¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6830016 ↗
• MalfunctionJan 10, 2017Bent; Activation, Positioning or Separation Problem; Bent; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT DEPLOYMENT DIFFICULTY AND STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A CONTRALATERAL APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). AFTER PREDILATION, A 7MM-180MM/130CM INNOVA¿ STENT WAS ADVANCED TO THE TARGET LESION. THE THUMBWHEEL USED WITH NORMAL FORCE UNTIL THE WHITE ARROW WAS VISIBLE. THE STENT WAS DEPLOYED WITHOUT ISSUE WITH THE THUMBWHEEL UP TO 12CM. THEN THE PULL GRIP WAS ATTEMPTED TO BE PULLED, BUT IT WAS VERY HARD AND COULD NOT PULL AT ALL. WHILE REMOVING THE DEVICE, THE STENT WAS STRETCHED AND PULLED OUT FROM THE DELIVERY SYSTEM AND IMPLANTED INSIDE THE PATIENT'S BODY. THE 18CM STENT WAS STRETCHED TO ABOUT 26CM. THE PROCEDURE WAS COMPLETED. THE PULL GRIP WAS ABLE TO PULL WITHOUT RESISTANCE ENCOUNTERED POST PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6236387 ↗
• MalfunctionNov 17, 2016Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE DEVICE BECAME ENTRAPPED ON THE GUIDEWIRE. AN INNOVA¿ SELF EXPANDING STENT WAS SELECTED FOR A STENOSIS DILATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY. THE STENT WAS PLACED USING A NON-BSC GUIDEWIRE WITH AN EXTENSION ATTACHED. IT FELT DIFFICULT TO PULL DURING PLACEMENT WHEN PULLING THE PULL GRIP. HOWEVER, THEY WERE ABLE TO DEPLOY THE STENT AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. AFTER PLACEMENT, THEY WERE UNABLE TO PULL OUT THE DEVICE WITH THE GUIDEWIRE OVER THE CATHETER FROM THE SHEATH. THE GUIDEWIRE AND CATHETER HAD TO BE PULLED OUT TOGETHER. IT APPEARED THAT THE EXTENSION BECAME STUCK IN THE INTERNAL PART OF THE INNOVA GRIP. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6111346 ↗

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-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
• 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