Indy OTW G51835Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002518353), received between Sep 7, 2016 and Aug 18, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS PROVIDED ON 13AUG2025. THE ACCESS SITE WAS THE LEFT GROIN. STENT GRAFT PLACEMENT FOR AN ABDOMINAL ANEURYSM WAS PERFORMED. NO CALCIFICATION OR TORTUOSITY WAS PRESENT IN THE PATIENT'S VESSELS USED FOR INTRODUCTION OF THE DEVICES. NO RESISTANCE WAS ENCOUNTERED DURING INSERTION. THE COOK INDY OVER THE WIRE VASCULAR RETRIEVER WIRE PARTIALLY SEPARATED FROM THE CATHETER OUTSIDE THE PATIENT. ONE OF THE SNARE LOOPS BROKE. WHEN REMOVING THE COOK INDY OVER THE WIRE VASCULAR RETRIEVER FROM THE SHEATH, OUTSIDE THE PATIENT, PART OF THE LOOP THAT COULD NOT BE PULLED BACK INTO THE DEVICE GOT CAUGHT IN THE SHEATH AND WAS SEPARATED. A PHOTO WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER CONFIRMED THAT THE WIRE IN THE BACKGROUND OF THE PROVIDED PHOTO REPRESENTS A PORTION OF THE SEPARATED COOK INDY OVER THE WIRE VASCULAR RETRIEVER. NO ADDITIONAL PHOTOS CAN BE PROVIDED. THE PROCEDURE WAS COMPLETED AS INTENDED. NO PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. NO PATIENT HEALTH HAZARDS. NO PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL TREATMENTS OR PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828455 ↗
• MalfunctionSep 8, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THE PACKAGING FOR THE INDY OTW VASCULAR RETRIEVER WAS FOUND TO BE UNSEALED. WHEN STAFF PULLED THE DEVICE FROM THE SHELF, IT ALMOST FELL OUT OF THE PACKAGING. IT WAS OBSERVED THAT THE PACKAGING WAS UNSEALED AT BOTH THE TOP AND BOTTOM ENDS. THE DEVICE WAS NOT USED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382898 ↗
• MalfunctionSep 6, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF AN INDY OTW VASCULAR RETRIEVER WAS FOUND TO BE UNSEALED DURING A ENDOVASCULAR ABDOMINAL AORTIC REPAIR (EVAR) AND LEFT IBD PROCEDURE. AS THE RETRIEVER WAS HANDED TO THE NURSING STAFF, THE OUTER PACKAGING WAS OBSERVED TO BE UNSEALED, WITH THE DISTAL END COMPLETELY OPENED. THE INNER PACKAGING WAS SEALED. THE RETRIEVER WAS REPLACED WITH ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15364410 ↗
• InjuryApr 15, 2019Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE LAST MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516235 ↗
• InjuryJun 14, 2018Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE DOCTOR WAS USING AN INDY OTW VASCULAR RETRIEVER WITH EXCEPTIONAL FORCE AND IT EVENTUALLY BROKE. AS REPORTED, THE DOCTOR WAS ATTEMPTING TO RETRIEVE A COVERED BALLOON EXPANDABLE STENT THAT HAD COME OFF ITS BALLOON. THE PHYSICIAN WAS NOT DOING THIS OVER A WIRE. AT THE TIME, THE DOCTOR WAS ADVISED THIS WAS OFF LABEL USE OF THE DEVICE. IT WAS OBVIOUS THAT THE STENT THE DOCTOR WAS ATTEMPTING TO RETRIEVE WAS JAMMED/STUCK IN THE PATIENT SOMEHOW. HE WAS APPLYING SIGNIFICANT FORCE AND BEGAN TO PULL THE INNER SEGMENT OF THE SNARE OUT THROUGH THE OUTER SHEATH. THE DOCTOR WAS ADVISED THAT THE SNARE AND SHEATH ARE SUPPOSED TO BE REMOVED TOGETHER AND WITH LESS FORCE APPLIED. UPON REMOVAL OF THE SNARE IT WAS FOUND THAT THE WIRE LOOPS OF THE SNARE WERE STILL INSIDE THE PATIENT. THE WIRES LOOPS WERE LATER RETRIEVED WITH ALLIGATOR FORCEPS. THERE WAS NO UNINTENDED SECTION OF THE DEVICE REMAINING INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7603359 ↗
• InjuryApr 30, 2018Break; Break

  IT WAS REPORTED THE MALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WITH AN INTERNAL BRANCHED DEVICE (IBD). AS REPORTED, WHILE SNARING THE WIRE THROUGH THE PRE-LOADED CATHETER FROM THE IBD THE INDY OTW VASCULAR RETRIEVER WAS DIFFICULT TO REMOVE AND BROKE IN THE PATIENT. THERE WAS NO VISIBLE REASON FOR THE DIFFICULT REMOVAL. THE CATHETER WAS REMOVED BUT THEY HAD TO RETRIEVE THE SNARE LOOP IN THE EXTERNAL ILIAC BY A CROSSOVER PROCEDURE WITH AN ADDITIONAL INDY SNARE AND THE USE OF A SINGLE LOOP GOOSE NECK SNARE KIT. THE EXTERNAL ILIAC WAS STENTED WITH A SELF-EXPANDABLE UNCOVERED STENT AND THE SNARE WAS RETRIEVED SUCCESSFULLY. THE INITIAL REPORTER STATED "THERE WAS A LOT OF BLOOD LOSS AND IT WAS A VERY LONG OPERATION." THE PATIENT HAS BEEN RELEASED FROM THE HOSPITAL.

  Patient problems: Blood Loss; Foreign Body In Patient; No Code Available

  MAUDE report 7472243 ↗
• InjuryMar 30, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ABDOMINAL AORTIC ANEURYSM (AAA) AND ILIAC BRANCH PROCEDURE, USING AN INDY OTW VASCULAR RETRIEVER, THE SNARE BROKE DURING THE CROSSOVER & REMAINED IN THE PATIENTS AORTA. IT WAS ALSO REPORTED THAT AN INTERVENTION WAS PERFORMED TO RETRIEVE THE DEVICE PORTION HOWEVER, RETRIEVAL WAS NOT SUCCESSFUL AND THE DEVICE WILL REMAIN IN THE PATIENT'S BODY. THE INITIAL REPORTER STATES THAT THE PATIENT DID NOT HAVE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6445777 ↗
• InjurySep 7, 2016Material Separation; Material Separation

  IT WAS REPORTED DIFFICULT CANNULATION OF THE CONTRALATERAL LIMB, REQUIRING CANNULATION FROM A SUPERIOR APPROACH WAS EXPERIENCED DURING THE PROCEDURE ON THE (B)(6) YEAR OLD FEMALE PATIENT. WHEN SNARING THE THRU AND THRU WIRE IN THE COMMON ILIAC ARTERY, THE WIRE HAD ADVANCED DOWN THE SIDE OF THE 14FR SHEATH THAT THE INDY SNARE HAD BEEN INTRODUCED THROUGH. AFTER SNARING THE WIRE HIGH AND THEN SUBSEQUENTLY REMOVING VIA THE 14FR SHEATH, RESISTANCE WAS FELT AND THE SNARE DETACHED FROM THE END OF ITS DELIVERY SYSTEM .THE SNARE WAS NOTED TO BE JUST INSIDE THE DISTAL END OF THE 14FR SHEATH. TO REMOVE THE DETACHED SNARE, A 5MM BALLOON WAS ADVANCED AND INFLATED AT THE DISTAL END OF THE SHEATH AND THEN THE 14FR SHEATH WAS REMOVED COMPLETELY AND THE SNARE WAS RETRIEVED. A 14FR SHEATH WAS THEN REINSERTED FOR HEMOSTASIS AND A SECOND INDY SNARE WAS OPENED AND USED WITHOUT ANY ISSUES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5933093 ↗