Torcon NBRecalls & reported problems across all models
Cook Incorporated · 79 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 68
We found 79 models of Torcon NB by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Oct 18, 2016 and Feb 19, 2026 — classified as 4 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Material Separation” (10 reports).
68 FDA recall records name at least one of these models by its device identifier.
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
Reports received per month, all models
Torcon NB 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.
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0491-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0490-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0489-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0488-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0487-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0486-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0484-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0483-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0482-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0481-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0479-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0478-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0477-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0476-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0475-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0474-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0473-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0472-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0471-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0470-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0469-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0468-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0467-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0466-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0465-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0464-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0463-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0461-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0460-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Oct 21, 2019Terminated
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Z-0459-2020 · Root cause: Process change control · Recall details · FDA record ↗
…and 38 older recalls, listed on each model's page.
Most reported Torcon NB problems
Device problems
- Material Separation10
- Detachment of Device or Device Component6
- Break5
- Device Contaminated During Manufacture or Shipping3
- Material Puncture/Hole2
- Contamination /Decontamination Problem1
- Crack1
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Patient Involvement8
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient6
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- Thrombosis/Thrombus1
Torcon NB models
79 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Torcon NB G10741CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall4 reports
- Torcon NB G05955CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall3 reports
- Torcon NB G06005CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- Torcon NB G06108CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- Torcon NB G08895CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- Torcon NB G06074CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Torcon NB G07268CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Torcon NB G08153CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Torcon NB G09521CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Torcon NB G09631CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Torcon NB G10599CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Torcon NB G11026CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Torcon NB G12517CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Torcon NB G13077CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Torcon NB G04788CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G04922CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G05018CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G05922CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G05923CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G05924CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G05925CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G05928CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G05975CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G05976CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G05979CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G05997CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G06039CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G06227CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G06236CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G06282CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G06607CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G06622CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G06827CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G07099CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G07300CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G07940CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G08201CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G08591CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G08878CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G08985CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G09757CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G09875CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10262CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10598CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10661CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10727CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10733CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10742CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10748CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10750CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10751CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10756CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10796CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10885CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10924CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10930CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G10998CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G11749CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G12783CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G27617CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G27640CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G27689CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G27702CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G30163CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G32465CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G47168CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G47185CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G47192CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Torcon NB G04789CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Torcon NB G05974CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Torcon NB G06749CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Torcon NB G05874CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Torcon NB G05988CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Torcon NB G06240CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Torcon NB G10755CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Torcon NB G10822CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Torcon NB G27713CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Torcon NB G31422CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Torcon NB G47032CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
Recent Torcon NB adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2026Detachment of Device or Device Component
AS REPORTED, A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER WAS USED DURING A CARDIAC CATHETERIZATION AND AORTIC RADIOGRAPHY PROCEDURE. DURING THE PROCEDURE, AN UNSPECIFIED POWER INJECTOR WAS USED TO DELIVER CONTRAST MEDIA AT A PRESSURE OF EIGHT HUNDRED POUNDS PER SQUARE INCH (PSI), WITH A VOLUME OF FORTY CUBIC CENTIMETERS (CC) OVER TWO SECONDS. THE HUB OF THE CATHETER SEPARATED FROM THE CATHETER BODY DURING THIS PROCESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SEPARATED CATHETER WITH A NEW UNSPECIFIED DEVICE. THE SEPARATED CATHETER WAS MANUALLY REMOVED FROM THE PATIENT BY HAND. 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 24385581 ↗MalfunctionJan 7, 2026Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED ON 20FEB2026. THE PROCEDURE INVOLVED AORTIC RADIOGRAPHY, AND THE CONTRAST MEDIA PRESSURE WAS AT 40CC FOR TWO SECONDS. THE HUB OF ONE DEVICE SEPARATED, NOT TWO AS ORIGINALLY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23993734 ↗MalfunctionDec 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED 14JAN2026. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY. THE CATHETER WAS ADVANCED THROUGH ANOTHER MANUFACTURER¿S SHEATH, OVER ANOTHER MANUFACTURER¿S WIRE GUIDE. THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED. BECAUSE PART OF THE CATHETER SHAFT WAS OUTSIDE OF THE BODY WHEN THE HUB SEPARATED, THE CATHETER SHAFT WAS REMOVED BY HAND. A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936201 ↗MalfunctionMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING AN UPPER EXTREMITY SHOULDER EMBOLIZATION, THE HUB OF A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER SEPARATED UPON THE SECOND POWER INJECTION AT 750 PSI. THE CATHETER HUB WAS FLUSHED WITH HEPARINIZED SALINE. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY TO TARGET THE LEFT UPPER EXTREMITY, AND THE CATHETER WAS ADVANCED THROUGH ANOTHER MANUFACTURER¿S 5-FRENCH SHEATH. THE ANATOMY WAS NOT STENOSED, TORTUOUS, OR CALCIFIED, AND RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR ADVANCEMENT OF THE CATHETER. THE PATIENT WAS REPORTEDLY RADIATED TWICE BEFORE THE USER NOTICED THAT THE HUB HAD SEPARATED. THE CATHETER WAS PULLED OUT OF THE PATIENT, AND ANOTHER CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS HOSPITALIZED FOR A PRE-SCHEDULED SURGERY AFTER THE EMBOLECTOMY. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105735 ↗MalfunctionJan 26, 2024Break; Break
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 18587867 ↗MalfunctionNov 21, 2023Difficult to Remove; Difficult to Remove
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 18181945 ↗MalfunctionOct 6, 2023Break; Break
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 17886416 ↗MalfunctionJun 14, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, DURING INSPECTION, A FOREIGN DARK "PARTICLE" WAS FOUND INSIDE THE PACKAGING OF A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER. THE DEVICE WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14684169 ↗MalfunctionFeb 18, 2022Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem; Device Contaminated During Manufacture or Shipping; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT UPON REMOVING A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER FROM THE BOX, THE DISTRIBUTOR FOUND A HAIR INSIDE THE DEVICE PACKAGING. AS REPORTED, THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13560502 ↗MalfunctionOct 4, 2021Device 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 12568198 ↗InjurySep 9, 2021Material Separation; Material Separation
AS REPORTED, DURING AN UNSPECIFIED ARTERIAL PROCEDURE IN THE THORACIC REGION, THE END OF A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER SEPARATED IN THE PATIENT. THE SEPARATED FRAGMENT WAS SNARED FROM THE PATIENT, WHO IS REPORTEDLY RECOVERING WELL. THE PROCEDURE WAS PROLONGED, AND THE PATIENT WAS EXPOSED TO ADDITIONAL RADIATION DURING RETRIEVAL OF THE DEVICE, DURING WHICH MULTIPLE CATHETER EXCHANGES AND MANIPULATIONS WERE PERFORMED; HOWEVER, THERE HAS BEEN NO REPORT THAT THE PATIENT EXPERIENCED ANY HARM AS A RESULT. NORMAL TORTUOSITY OF THE ARCH VESSELS WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12445820 ↗MalfunctionApr 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11700402 ↗MalfunctionMar 25, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in 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 11569300 ↗InjuryMar 14, 2021Material Separation; Material Separation
AS REPORTED, DURING A PROCEDURE INVOLVING RETRIEVAL OF ANOTHER MANUFACTURER¿S VASCULAR PLUG, A TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER SEPARATED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A RIGHT PORTAL EMBOLIZATION PROCEDURE PRIOR TO A RIGHT HEPATECTOMY FOR HEPATO-CELLULAR CARCINOMA. WHEN AN X-RAY WAS OBTAINED, THE RADIOLOGIST NOTICED THAT THE OTHER MANUFACTURER'S EMBOLIZATION IMPLANT/VASCULAR PLUG HAD MIGRATED TOWARD THE HEART, AT THE LEVEL OF THE LEFT PULMONARY ARTERY. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR ATTEMPTED RETRIEVAL OF THE IMPLANT. THE COMPLAINT DEVICE, WHICH WAS USED TO CATHETERIZE THE RIGHT HEART CHAMBERS, SEPARATED DURING THE ATTEMPTED REMOVAL PROCEDURE. THE SEPARATED PORTION OF THE DEVICE AND THE EMBOLIZATION DEVICE WERE UNABLE TO BE RETRIEVED. THE PATIENT UNDERWENT A THORACOTOMY AND ARTERIOTOMY THE NEXT DAY TO RETRIEVE THE IMPLANT AND SEPARATED PORTION OF THE CATHETER FROM THE PULMONARY ARTERY. THROMBOSIS WAS REPORTED IN ALL ARTERIAL BRANCHES OF THE LEFT LOWER LOBE, REQUIRING ANTICOAGULATION FOR THREE MONTHS. THE HEPATECTOMY WAS POSTPONED AND MANAGEMENT OF CANCER WAS DELAYED.
Patient problems: Foreign Body In Patient; Thrombosis/Thrombus
MAUDE report 11478799 ↗MalfunctionDec 14, 2020Crack; Material Separation; Material Split, Cut or Torn; Crack; Material Separation; Material Split, Cut or Torn
ADDITIONAL INFORMATION WAS RECEIVED 23DEC2020. THE TIP WAS CRACKED. THE DEVICE DID NOT SEPARATE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11004141 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page