CookRecalls & reported problems across all models

We found 11 models of Cook by William A. Cook Australia Pty. Ltd. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2022 and Aug 25, 2026 — classified as 24 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Endoleak” (2 reports).

1 FDA recall record name at least one of these models by its device 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. 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

Cook recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 7, 2023Class IIOpen, Classified

   The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the patient.

   Z-0722-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Cook problems

Cook models

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

• COOK G44429

  Accessory, assisted reproduction
  1 recall0 reports
• Cook G55253

  NEEDLE, ASSISTED REPRODUCTION
  6 reports
• Cook G55477

  NEEDLE, ASSISTED REPRODUCTION
  4 reports
• Cook G55493

  NEEDLE, ASSISTED REPRODUCTION
  4 reports
• COOK G60340

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 reports
• Cook G38432

  NEEDLE, ASSISTED REPRODUCTION
  2 reports
• Cook G55788

  NEEDLE, ASSISTED REPRODUCTION
  2 reports
• COOK G60345

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Cook G55797

  NEEDLE, ASSISTED REPRODUCTION
  1 report
• COOK G60342

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• COOK G60344

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report

Recent Cook adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Fluid/Blood Leak

  The implant procedure was an iliac branch with a ZBIS on the left, with competitor grafts for everything else: EVAR hypo stent with VBX, gore limbs to bridge. They sealed into the top of the ZBIS with the 14.5 ispi leg of the exculder. Brisk endoleak was visible at level of the ZBIS flow divider. They then relined the VBX thinking maybe it was a type c and occuleded above the flow divider with a CODA. the leak was still there. They then relined the ipsi limb with another limb. Leak was still there. Reballooned and took different angles to rule out type 2 or any other leak elsewhere. Doctor seems confident now after reflection it could only be coming from the ZBIS at the area of the flow divider somehow. (The physician called the Cook representative to complain that she is fairly certain now that this is Type 4 endoleak of some kind due to the graft.)

  Patient problems: Clinical Endoleak

  MAUDE report 50423841 ↗
• InjuryJun 1, 2026Device Endoleak

  AS REPORTED PER COMPLAINT EMAIL: "GOOD AFTERNOON. I AM ONCE AGAIN REPORTING MORE FABRIC LEAKS FROM (REDACTED) ENDOGRAFTS. THESE WERE PICKED UP ON FOLLOW UP SCAN TODAY WITH THE SURGEON. THE CASE WAS ORIGINALLY PERFORMED ON (REDACTED). THE ENDOLEAK IS REPORTED TO HAVE PERSISTED FROM THE LIMBS AND (REDACTED) DEVICES." FURTHER INFORMATION PROVIDED STATED: THE PHYSICIAN ATTRIBUTED THE CAUSE TO A FABRIC LEAK IN THE DEVICE. NO PRE-EXISTING ANATOMICAL CONDITIONS (SUCH AS VESSEL CALCIFICATION OR TORTUOSITY) WERE IDENTIFIED, AND NO DIFFICULTIES WERE ENCOUNTERED DURING THE ORIGINAL DEPLOYMENT. TO TREAT THE ENDOLEAK, A 16MM GRAFT WAS USED TO RELINE THE AFFECTED AREA, AND ADDITIONAL GRAFTS WERE ALSO IMPLANTED AS ADJUNCTIVE MEASURES. NO HIGH BLOOD PRESSURE OR GRAFT OBSTRUCTION WAS OBSERVED DURING THE ENDOLEAK EVENT. THE IMPLANTED DEVICES WERE NOT AVAILABLE FOR RETURN. THE PATIENT CONTINUED TO BE MONITORED FOLLOWING THE INTERVENTION, WITH NO FURTHER ADVERSE OUTCOME NOTED AT THE TIME OF REPORTING.

  Patient problems: Clinical Endoleak

  MAUDE report 25354515 ↗
• InjuryJun 1, 2026Device Endoleak

  AS REPORTED PER COMPLAINT EMAIL: "GOOD AFTERNOON. I AM ONCE AGAIN REPORTING MORE FABRIC LEAKS FROM (REDACTED) ENDOGRAFTS. THESE WERE PICKED UP ON FOLLOW UP SCAN TODAY WITH THE SURGEON. THE CASE WAS ORIGINALLY PERFORMED ON (REDACTED). THE ENDOLEAK IS REPORTED TO HAVE PERSISTED FROM THE LIMBS AND ZBIS DEVICES (ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION, DISTAL DIA 12 MM, COMMON ILIAC SEGMENT LEN 61 MM, EXTERNAL ILIAC SEGMENT LEN 41 MM)." FURTHER INFORMATION PROVIDED STATED: THE PHYSICIAN ATTRIBUTED THE CAUSE TO A FABRIC LEAK IN THE DEVICE. NO PRE-EXISTING ANATOMICAL CONDITIONS (SUCH AS VESSEL CALCIFICATION OR TORTUOSITY) WERE IDENTIFIED, AND NO DIFFICULTIES WERE ENCOUNTERED DURING THE ORIGINAL DEPLOYMENT. TO TREAT THE ENDOLEAK, A 16 MM GRAFT WAS USED TO RELINE THE AFFECTED AREA, AND ADDITIONAL GRAFTS WERE ALSO IMPLANTED AS ADJUNCTIVE MEASURES. NO HIGH BLOOD PRESSURE OR GRAFT OBSTRUCTION WAS OBSERVED DURING THE ENDOLEAK EVENT. THE IMPLANTED DEVICES WERE NOT AVAILABLE FOR RETURN. THE PATIENT CONTINUED TO BE MONITORED FOLLOWING THE INTERVENTION, WITH NO FURTHER ADVERSE OUTCOME NOTED AT THE TIME OF REPORTING.

  Patient problems: Clinical Endoleak

  MAUDE report 25349010 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  DESCRIPTION OF EVENT PER THE COMPLAINT EMAIL: DR HOSP UNC IDE PRELOADED FEN PROX CASE WITH ZBIS RT ILIAC. PRODUCT: ZBIS-10-45-41-US LOT A1201336 LONG STORY BUT DURING THE ADVANCING THE ZBIS THE OPERATOR THOUGHT THAT THE DILATOR HIT THE RT RENAL AND SMA BRANCH STENTS. AT THE END OF PROCEDURE, THEY ASSESS THE STATUS OF THE BRANCHES. THEY CONFIRMED THE SMA WAS OCCLUDED. SEVERAL ATTEMPTS WERE MADE AND EVENTUALLY GAINED ACCESS AND REPAIRED THE SMA STENT. PATIENT WAS COMPLETED WITHOUT ANY COMPLICATIONS. PATIENT OUTCOME: THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 24512429 ↗
• MalfunctionMar 4, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE ADVANCING THE ZBIS THE OPERATOR THOUGHT THAT THE DILATOR HIT THE RT RENAL AND SMA BRANCH STENTS . AT THE END OF PROCEDURE THEY ASSESS THE STATUS OF THE BRANCHES. THEY CONFIRMED THE SMA WAS OCCLUDED. SEVERAL ATTEMPTS WERE MADE AND EVENTUALLY GAINED ACCESS AND REPAIRED THE SMA STENT. PATIENT WAS COMPLETED WITHOUT ANY COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 24510711 ↗
• InjuryMar 4, 2026Material Separation

  THE PART OF THE BEACON TIP CATHETER BUILT INTO THE DELIVERY SYSTEM WAS LEFT IN THE EXTERNAL ILIAC WHEN IT WAS DEPLOYED. THE PORTION OF THE DEVICE WAS NOT RETRIEVED. THEY FINISHED THE PROCEDURE WAS FINISHED REGARDLESS OF THE PORTION LEFT BEHIND.

  Patient problems: Insufficient Information

  MAUDE report 24506626 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  THE ICAST STENT (NOT A COOK MANUFACTURED DEVICE) IN THE INTERNAL ILIAC AND THE SIDE BRANCH OF THE ZBIS GRAFT WAS DEPLOYED BEFORE THE THROUGH AND THROUGH CATHETER WAS REMOVED. UPON REMOVAL OF THE DILATOR TO THE MAIN DEVICE, THE CATHETER BECAME TRAPPED BEHIND THE ICAST STENT AND SNAPPED - BETWEEN THE STENT AND THE SIDE BRANCH.THE PIECE OF THE CATHETER IS TRAPPED BEHIND THE ICAST STENT INSIDE THE SIDE BRANCH OF THE ILIAC BRANCH DEVICE. FURTHER INFORMATION PROVIDED STATES:ON (b)(6) 2026, A COOK ZENITH BRANCH ILIAC STENT (LOT A1199911) WAS IMPLANTED IN A PATIENT WITH A PRE-EXISTING AORTO-ILIAC ANEURYSM. THE PROCEDURE ALSO INVOLVED USE OF ANOTHER MANUFACTURER'S STENT, STENT-GRAFT, SHEATH, AND A COOK INDY OTW SNARE. A COOK REPRESENTATIVE WAS PRESENT, AND THE SAME DAY THE TEAM NOTED A DEVICE-RELATED NONCONFORMANCE; HOWEVER, NO ADVERSE EVENTS OCCURRED, AND NO ADDITIONAL PROCEDURES WERE REQUIRED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194164 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER: THE ICAST STENT IN THE INTERNAL ILIAC AND THE SIDE BRANCH OF THE ZBIS WAS DEPLOYED BEFORE THE THROUGH AND THROUGH CATHETER WAS REMOVED. UPON REMOVAL OF THE DILATOR TO THE MAIN DEVICE, THE CATHETER BECAME TRAPPED BEHIND THE STENT (ANOTHER MANUFACTURER) AND SNAPPED- BETWEEN THE STENT AND THE SIDE BRANCH. THE PIECE OF THE CATHETER IS TRAPPED BEHIND THE ICAST STENT INSIDE THE SIDE BRANCH OF THE ILIAC BRANCH DEVICE. FURTHER INFORMATION PROVIDED STATES: ON (B)(6) 2026, A COOK ZENITH BRANCH ILIAC STENT (LOT A1199911) WAS IMPLANTED IN A PATIENT WITH A PRE-EXISTING AORTO-ILIAC ANEURYSM. THE PROCEDURE ALSO INVOLVED USE OF ANOTHER MANUFACTURER'S STENT, STENT-GRAFT, SHEATH, AND A COOK INDY OTW SNARE. A COOK REPRESENTATIVE WAS PRESENT, AND THE SAME DAY THE TEAM NOTED A DEVICE-RELATED NONCONFORMANCE; HOWEVER, NO ADVERSE EVENTS OCCURRED, AND NO ADDITIONAL PROCEDURES WERE REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24176416 ↗
• MalfunctionAug 26, 2024Material Disintegration; Scratched Material; Material Disintegration; Scratched Material

  DURING AN EGG RETRIEVAL THE USER FOUND SOME PLASTICS IN THE FLUID. THEY SAVED THE NEEDLE AND PIECES OF PLASTICS FOR EVALUATION. THE USER THOUGHT IT WAS MAYBE THE TUBES WERE DOING IT BUT THAT WOULDN¿T EXPLAIN LAST WEEK'S PROBLEM [PR(B)(4)]. ADDITIONAL INFORMATION RECEIVED 20TH AUG 2024: "I WAS THE EMBRYOLOGIST WHO SAW THE SHARDS OF PLASTIC IN THE FOLLICULAR FLUID FOR THE INCIDENT ON AUGUST 12TH. THE REASON THIS CAUGHT MY EYE WAS THAT THE PLASTIC SHARDS WERE BURIED IN THE CELLS (CUMULUS CELLS) AROUND THE EGG. I NOTICED THE SHARDS BEFORE I PICKED UP THE EGG WITH MY PIPET SO I KNOW THEY WERE THERE BEFORE I HAD A CHANCE TO HANDLE THE EGG. I ALSO SAW SMALL SHARDS OF PLASTIC FLOATING IN THE DISH OF FLUID. I INCLUDED THOSE SHARDS AS WELL AS THE CUMULUS THAT WAS CUT OFF THE EGG IN THE SAMPLES THAT WERE SENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071980 ↗
• MalfunctionAug 25, 2024Material Disintegration; Scratched Material; Material Disintegration; Scratched Material

  AFTER AN IVF RETRIEVAL, A PIECE OF PLASTIC WAS SEEN AS THE LAB WAS LOOKING THROUGH THE FLUID UNDER MICROSCOPE. THE NEEDLE HAS ALREADY BEEN PUT IN THE SHARPS BOX SO THERE IS NO WAY OF KNOWING WHICH ONE WE USED TODAY. THE LOT # A1153708 AND IT WAS THE OVUM ASPIRATION NEEDLE DOUBLE LUMEN REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20061135 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) HOSPITAL HAD AN ISSUE WITH 7 PATIENTS EXPERIENCING BLEEDING POST OVUM ASPIRATION WITH PRODUCT (FROM SAME LOT NUMBER). ALL SEVEN PATIENTS RECOVERED, A FEW REQUIRED STITCHES, SILVER NITRATE, AND EXTRA DAY IN HOSPITAL FOR OBSERVATIONS.

  Patient problems: Intra-Abdominal Hemorrhage

  MAUDE report 17905284 ↗
• InjuryOct 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) HOSPITAL HAD AN ISSUE WITH 7 PATIENTS EXPERIENCING BLEEDING POST OVUM ASPIRATION WITH PRODUCT (FROM SAME LOT NUMBER). ALL SEVEN PATIENTS RECOVERED, A FEW REQUIRED STITCHES, SILVER NITRATE, AND EXTRA DAY IN HOSPITAL FOR OBSERVATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Intra-Abdominal Hemorrhage

  MAUDE report 17892732 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXCESSIVE BLEEDING AFTER USING 2 NEEDLES (1 PATIENT).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17442721 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXCESSIVE BLEEDING AFTER USING 2 NEEDLES (1 PATIENT).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17442719 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TOO MUCH BLEEDING SO THAT PATIENTS ENDED UP GOING TO ER AFTER EGG RETRIEVAL. IT HAPPENED TO TWO PATIENTS IN A ROW ON WEDNESDAY (B)(6) 2023. ((B)(6) PATIENT 1 &(B)(6) PATIENT 2) THE PATIENTS REPORTED TO THE ER WITH PELVIC PAIN, DROP IN HEMATOCRIT AND REQUIRED PAIN MANAGEMENT. NO TRANSFUSION WAS REQUIRED. THE SAME PHYSICIAN PERFORMED BOTH EGG RETRIEVAL PROCEDURES. NO MORE THAN MINIMAL BLEEDING WAS NOTED IMMEDIATELY AFTER EACH SURGERY WAS PERFORMED. NO ABNORMALITY OR DAMAGE TO THE NEEDLES WAS IDENTIFIED ON OPENING, DURING OR AFTER USE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17442636 ↗

Other William A. Cook Australia Pty. Ltd. products

• Zenith32 models · 228 reports