Indy OTWRecalls & reported problems across all models

We found 2 models of Indy OTW by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2015 and Jan 27, 2026 — classified as 12 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Indy OTW problems

Indy OTW models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Indy OTW G51836

  Device, percutaneous retrieval
  17 reports
• Indy OTW G51835

  Device, percutaneous retrieval
  8 reports

Recent Indy OTW adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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