Indy OTW G51836Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002518360), received between Apr 22, 2015 and Jan 27, 2026 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Material Separation

  IT WAS REPORTED THAT THE SNARE OF AN INDY OTW VASCULAR RETRIEVER SEPARATED FROM THE CATHETER DURING A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE FOR A 71-YEAR-OLD MALE PATIENT. A COMPETITOR PULL-THROUGH WIRE WAS SELECTED FOR INSERTION OF THE DELIVERY SYSTEM. THE WIRE GUIDE WAS ADVANCED FROM THE LEFT BRACHIAL ARTERY INTO THE DESCENDING AORTA. THE INDY OTW VASCULAR RETRIEVER WAS INTRODUCED VIA A COMPETITOR'S 22FR SHEATH FROM THE RIGHT FEMORAL ARTERY AND THE COMPETITOR WIRE WAS SNARED. DURING THE ATTEMPT TO RETRIEVE THE WIRE, THE SNARE WAS SEVERED. THE REMAINING CATHETER WAS THEN REMOVED FROM THE PATIENT. FLUOROSCOPIC EXAMINATION REVEALED THAT THE SEVERED PORTION OF THE DEVICE WAS SLIGHTLY PROXIMAL TO THE 22FR SHEATH, AROUND THE THORACOABDOMINAL REGION AND REMAINING ON THE COMPETITOR WIRE USED TO GUIDE THE COMPLAINT DEVICE. AS THE 22FR SHEATH WAS ALREADY IN PLACE, A SECOND COMPETITOR WIRE AND INDY OTW VASCULAR RETRIEVER WERE INSERTED TO RETRIEVE THE SEVERED SNARE TIP. DURING RETRIEVAL, THE SEVERED SNARE BECAME ENTANGLED WITH THE SECOND WIRE. AS A RESULT, A THIRD INDY OTW VASCULAR RETRIEVER WAS USED TO CATCH AND PULL THE COMPETITOR WIRE, COMPLETING THE PULL-THROUGH. THE SEVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190574 ↗
• InjurySep 16, 2025Break; Material Separation; Break; Material Separation

  IN ADDITIONAL INFORMATION RECEIVED 29SEP2025 IT WAS REPORTED THAT THE PATIENT HAD NO SEVERE VESSEL CALCIFICATION OR TORTUOSITY. THE PHYSICIAN DID NOT ENCOUNTER DIFFICULTY ADVANCING THE SNARE ITSELF. THE ISSUE ONLY OCCURRED AFTER THE GUIDEWIRE WAS CAPTURED WHILE ATTEMPTING TO WITHDRAW THE SNARE INTO THE IN-SITU 12FR INTRODUCER.

  Patient problems: Unintended Loss of Vascular Access; Vascular Dissection

  MAUDE report 23064525 ↗
• MalfunctionMay 30, 2025Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116687 ↗
• InjuryDec 9, 2024Entrapment of Device; Entrapment of Device

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

  Patient problems: Foreign Body In Patient

  MAUDE report 20879164 ↗
• MalfunctionNov 22, 2024Break; Material Separation; Break; Material Separation

  ADDITIONAL INFORMATION RECEIVED ON 22NOV2024.THE COOK INDY OTW VASCULAR RETRIEVER WAS USED ALONG WITH A COMPETITOR'S SHORT 8FR INTRODUCER SHEATH THROUGH THE JUGULAR "TO CATCH AN IMPLANTED CHAMBER CATHETER, LOST IN THE SUPERIOR VENA CAVA". AFTER INTRODUCTION OF THE RETRIEVER THROUGH THE INTRODUCER SHEATH AND SNARE OF THE LOST CHAMBER CATHETER, THE DISTAL PORTION OF THE BLUE INNER CATHETER OF THE INDY OTW VASCULAR RETRIEVER SEPARATED FROM THE GUIDE INSIDE THE INTRODUCER AND HAD TO BE REMOVED. IT WAS UNSPECIFIED HOW IT WAS REMOVED. THERE WAS NO CALCIFICATION OR TORTUOSITY IN THE PATIENT'S VESSELS USED FOR INTRODUCTION OF DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20763500 ↗
• MalfunctionApr 18, 2024Unsealed Device Packaging; Unsealed Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19135278 ↗
• MalfunctionDec 21, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, A HAIR-LIKE FIBER WAS FOUND IN THE STERILE PACKAGING OF AN INDY OTW VASCULAR RETRIEVER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378022 ↗
• MalfunctionAug 23, 2023Contamination; Contamination

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604199 ↗
• InjuryMay 16, 2022Material Separation; Material Separation

  IT WAS REPORTED AN INDY OTW VASCULAR RETRIEVER SEPARATED DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE DEVICE WAS INTENDED TO BE USED TO CATCH A WIRE GUIDE DURING THE PROCEDURE. WHEN THE ILIAC LEG GRAFT WAS PLACED, THE SNARE CAUGHT ON THE SUPRARENAL STENT OF THE ILIAC LEG GRAFT AND THE SNARE COULD NOT BE REMOVED. THE USER PULLED ON THE SNARE DEVICE FORCEFULLY AND THE DEVICE SEPARATED AT THE JOINT OF THE CATHETER AND SNARE WIRE. THE CATHETER AND SNARE WIRE COMPONENT REMAINS INSIDE THE PATIENT NEAR THE CELIAC ARTERY IN THE AORTA. THE EVAR PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE IS NO PLANNED ADDITIONAL PROCEDURE TO RETRIEVE THE SEPARATION PORTION OF THE DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14407364 ↗
• MalfunctionMay 5, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A HAIR WAS OBSERVED INSIDE THE PRIMARY PACKAGING OF A INDY OTW VASCULAR RETRIEVER UPON INSPECTION BY THE DISTRIBUTOR. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286913 ↗
• MalfunctionJun 11, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND INSIDE THE STERILIZED PACKAGING OF A INDY OTW VASCULAR RETRIEVER. THE ISSUE WAS NOTICED AT THE DISTRIBUTION FACILITY, AND IT WAS NOTED THAT THE FOREIGN MATTER LOOKED LIKE BROWN PAPER.

  Patient problems: No Patient Involvement

  MAUDE report 10144924 ↗
• InjuryDec 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Code Available

  MAUDE report 9474883 ↗
• MalfunctionNov 5, 2019Unsealed Device Packaging; Unsealed Device Packaging

  NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 9278951 ↗
• MalfunctionOct 29, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THE CUSTOMER FOUND A PIECE OF PLASTIC-LIKE FOREIGN MATTER INSIDE THE UNOPENED PACKAGE. THE PACKAGE WAS NOT OPENED. NO ADVERSE EFFECTS TO A PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8016189 ↗
• InjuryAug 3, 2018Break; Break

  IT WAS REPORTED THE INDY OTW VASCULAR RETRIEVER SNARE TIP BROKE OFF DURING USE IN THE VESSEL. THE TIP IS CURRENTLY IN THE RIGHT COMMON ILIAC ARTERY BEHIND AN ILIAC COVERED STENT. ADDITIONAL INFORMATION REGARDING THIS EVENT WAS REQUESTED BY COOK. HOWEVER, ON 08/03/2018, IT WAS STATED THAT DUE TO THE POLICIES AT THE MAYO CLINIC NO ADDITIONAL INFORMATION FOR THIS EVENT WOULD BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7748217 ↗
• InjuryApr 20, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA (IVC) RETRIEVAL PROCEDURE USING AN INDY OTW VASCULAR RETRIEVER, THE ENTIRE TIP OF THE INDY OTW VASCULAR RETRIEVER BROKE OFF AND VENTURED INTO THE VENTRICLE. WITH THE USE OF ANOTHER MANUFACTURER'S DEVICE, THE PHYSICIAN WAS ABLE TO RETRIEVE ALL PIECES OF THE INDY OTW VASCULAR RETRIEVER. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6508191 ↗
• InjuryApr 22, 2015Material Separation

  AN EVAR WITH A ILIAC BRANCH DEVICE IMPLANTATION WAS BEING PERFORMED ON A (B)(6) MALE PATIENT. THE DOCTOR CAUGHT THE WIRE IN THE SNARE AND PULLED WITH SOME FORCE. THE INDY SNARE SNAPPED AND WAS LEFT FLOATING WITHIN THE AORTA. A CLOVER SNARE WAS THEN USED TO RETRIEVE THE PART OF THE INDY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign body, removal of

  MAUDE report 4730748 ↗