Cook G11916Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00827002119161), received between Mar 7, 2017 and Aug 8, 2025 — classified as 1 death, 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 2, 2026Open, Classified

   Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

   Z-1934-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, DURING THE SCREENING OF AN AUROUS CENTIMETER VESSEL SIZING CATHETER, A FOREIGN BODY WAS FOUND IN THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22752816 ↗
• MalfunctionJul 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, DURING AN ENDOLUMINAL ISOLATION PROCEDURE IN THE THORACIC AORTA FOR A PATIENT WITH AORTIC DISSECTION, AN UNSPECIFIED BLACK FOREIGN MATTER WAS DISCOVERED INSIDE THE PACKAGING OF THE 'AUROUS CENTIMETER VESSEL SIZING CATHETER'. THE ISSUE WAS DISCOVERED WHEN THE USER OPENED THE PACKAGE AND NOTED THAT THERE WAS FALLEN HAIR ON THE OPERATING TABLE AND UPON INSPECTION, THE USER DISCOVERED THERE WAS STILL FOREIGN MATTER INSIDE THE PACKAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING THE CATHETER. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ADVERSE EFFECTS DUE TO THIS EVENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531330 ↗
• MalfunctionJul 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, DURING AN ENDOLUMINAL ISOLATION PROCEDURE IN THE THORACIC AORTA FOR A PATIENT WITH AORTIC DISSECTION, A HAIR-LIKE FOREIGN MATTER WAS FOUND UPON INSPECTION IN THE STERILE PACKAGING OF THE 'AUROUS CENTIMETER VESSEL SIZING CATHETER'. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING THE CATHETER. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523785 ↗
• MalfunctionJul 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A FOREIGN BODY WAS DISCOVERED INSIDE THE PACKAGING OF THE 'AUROUS CENTIMETER VESSEL SIZING CATHETER'. THE ISSUE WAS NOTED DURING DEVICE INSPECTION WITHIN A DISTRIBUTION FACILITY, THEREFORE, THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394387 ↗
• MalfunctionJul 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A FOREIGN BODY WAS DISCOVERED INSIDE THE PACKAGING OF THE 'AUROUS CENTIMETER VESSEL SIZING CATHETER'. THE ISSUE WAS NOTED DURING DEVICE INSPECTION WITHIN A DISTRIBUTION FACILITY, THEREFORE, THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393938 ↗
• MalfunctionJun 25, 2025Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, DURING DEVICE INSPECTION UPON ARRIVAL TO A DISTRIBUTION FACILITY, AN AUROUS CENTIMETER VESSEL SIZING CATHETER'S STERILE PACKAGE WAS FOUND TO BE UNSEALED. THERE WAS NO PATIENT INVOLVEMENT, AS THIS WAS NOTED WITHIN A DISTRIBUTION FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331628 ↗
• MalfunctionDec 27, 2024Break; Break

  AS REPORTED, THE TIP OF AN AUROUS CENTIMETER VESSEL SIZING CATHETER SEPARATED DURING ANGIOGRAPHY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026606 ↗
• MalfunctionDec 13, 2024Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, UPON INSPECTION OF EIGHT AUROUS CENTIMETER VESSEL SIZING CATHETERS AT A HOSPITAL, THE SEAL WAS MISSING FROM ONE END OF THE PACKAGES. THERE WERE NO ADVERSE EFFECTS TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924150 ↗
• MalfunctionNov 18, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 20705316 ↗
• MalfunctionJun 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  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 19552156 ↗
• MalfunctionNov 17, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED BY THE DISTRIBUTOR, A HAIR WAS FOUND INSIDE THE PACKAGING OF A AUROUS CENTIMETER VESSEL SIZING CATHETER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160436 ↗
• MalfunctionSep 7, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 17697701 ↗
• MalfunctionMay 7, 2022Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, AN AUROUS CENTIMETER VESSEL SIZING CATHETER DEVELOPED A HOLE. THERE WAS REPORTEDLY NO TRAUMA TO THE CATHETER DURING PLACEMENT; HOWEVER, A HOLE WAS BLOWN IN THE CATHETER UPON THE FIRST USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14321747 ↗
• MalfunctionJun 4, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED, DURING THE DISTRIBUTOR INSPECTION OF AN AUROUS CENTIMETER VESSEL SIZING CATHETER, AN UNKNOWN PARTICLE WAS NOTED INSIDE OF THE PRIMARY PACKAGING OF THE PRODUCT. THIS DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10118678 ↗
• MalfunctionJan 17, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 9602309 ↗
• DeathJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Death

  MAUDE report 8822684 ↗
• MalfunctionApr 26, 2019Separation Problem; Separation Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8556167 ↗
• MalfunctionDec 18, 2018Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HUB OF THE AUROUS CENTIMETER VESSEL SIZING CATHETER HAD A CRACK ON IT, AND WHEN THE AND WHEN THE USER CONNECTED IT TO THE INJECTOR, "IT SPRAYED EVERYWHERE". ANOTHER DEVICE WAS USED FOR THE PROCEDURE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8176912 ↗
• MalfunctionDec 18, 2018Crack

  IT WAS REPORTED THAT THE HUB OF THE AUROUS CENTIMETER VESSEL SIZING CATHETER CRACKED WHEN THE USER ATTEMPTED TO INJECT FLUID THROUGH IT DURING A PULMONARY EMBOLISM PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8176899 ↗
• MalfunctionDec 18, 2018Crack

  IT WAS REPORTED THAT THE HUBS OF TWO OF THE AUROUS CENTIMETER VESSEL SIZING CATHETERS (OTHER DEVICE IN MDR 1820334-2018-03846) HAD CRACKED VERTICALLY, JUST AFTER THE CATHETER WAS CONNECTED TO THE POWER INJECTOR BUT BEFORE THE INJECTION TOOK PLACE. THERE HAD BEEN NO VISIBLE CRACKS DURING PREPARATION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, BUT THERE WERE NO INJURIES OR ADDITIONAL PROCEDURE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8176871 ↗
• MalfunctionDec 18, 2018Crack

  IT WAS REPORTED THAT THE HUBS OF TWO OF THE AUROUS CENTIMETER VESSEL SIZING CATHETERS (OTHER DEVICE IN MDR 1820334-2018-03847) HAD CRACKED VERTICALLY, JUST AFTER THE CATHETER WAS CONNECTED TO THE POWER INJECTOR BUT BEFORE THE INJECTION TOOK PLACE. THERE HAD BEEN NO VISIBLE CRACKS DURING PREPARATION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, BUT THERE WERE NO INJURIES OR ADDITIONAL PROCEDURE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8175368 ↗
• MalfunctionDec 17, 2018Break; Material Puncture/Hole

  THE COMPLAINANT REPORTED THAT A HOLE "BLEW OUT" AT THE PROXIMAL END OF THE AUROUS CENTIMETER VESSEL SIZING CATHETER DURING THE FINAL RUN OF THE PROCEDURE. THIS PART OF THE CATHETER WAS OUTSIDE OF THE BODY WHEN IT HAPPENED. THE PROCEDURE WAS FOR AN AAA (ABDOMINAL AORTIC ANEURYSM) REPAIR VIA THE GROINS AND ABDOMEN. THIS WAS A 6-7 HOUR PROCEDURE, AND THE CATHETER HAD BEEN INSERTED AND REMOVED SEVERAL TIMES. THERE WAS SUSPICION FOR A KINK AT THE LOCATION OF THE HOLE. IT WAS ALSO NOTED THAT A POWER INJECTOR WAS USED AT 1000 PSI. THIS PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8170056 ↗
• MalfunctionOct 24, 2018Leak/Splash; Leak/Splash

  THE FOLLOWING COMPLAINT WAS RECEIVED VIA MEDWATCH MW5079740. IT WAS REPORTED THAT DURING A "VASCULAR ANGIOGRAPHY AND INTERVENTION" PROCEDURE, THE TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER LEAKED. ACCORDING TO THE INITIAL REPORTER, AN UNKNOWN 0.014 WIRE GUIDE WAS USED, AND THE COMPLAINT DEVICE TIGHTENED WELL AROUND THE UNKNOWN WIRE. WHEN ISOVUE 250 CONTRAST WAS INJECTED VIA THE LUER LOCK PORT, HOWEVER, CONTRAST SPRAYED AROUND THE WIRE AND INTO THE PHYSICIAN'S EYES. THERE HAVE BEEN NO ADVERSE EVENTS REPORTED REGARDING THIS COMPLAINT. THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION, AND THERE HAS BEEN NO CONTACT INFORMATION PROVIDED TO REQUEST ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999694 ↗
• MalfunctionOct 8, 2018Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7942465 ↗
• MalfunctionSep 14, 2018Material Separation; Material Separation

  IT WAS REPORTED, THE PHYSICIAN CONFIRMED AIR ENTRY IN THE AUROUS CENTIMETER VESSEL SIZING CATHETER WHEN PERFORMING FINAL CONFIRMATORY ANGIOGRAPHY DURING THE STENT GRAFT PLACEMENT ALTHOUGH, IT COULD BE USED WITH NO PROBLEM BEFORE THE FINAL ANGIOGRAPHY. HE STOPPED USING THE DEVICE. THE DEVICE WAS REPLACED WITH ANOTHER AUROUS CENTIMETER VESSEL SIZING CATHETER TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878632 ↗