Cook Incorporated
FDA adverse event reports naming Cook Incorporated as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: COOK INCORPORATED.
- Total reports
- 1,224
- Deaths
- 30
- Injuries
- 563
- Malfunctions
- 591
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Introducer, CatheterDYB273
- System, Endovascular Graft, Aortic Aneurysm TreatmentMIH165
- Wire, Guide, CatheterDQX95
- Catheter, Intravascular, DiagnosticDQO82
- Hemostatic Metal Clip For The Gi TractPKL52
- Catheter, PercutaneousDQY36
- Filter, Intravascular, CardiovascularDTK36
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ32
- Stent, UreteralFAD24
- Stents, Drains And Dilators For The Biliary DuctsFGE24
Recent recalls
- 2026-05-01Open, ClassifiedUnder Investigation by firm
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
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.
- 2026-05-01Open, ClassifiedUnder Investigation by firm
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
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.
- 2026-05-01Open, ClassifiedUnder Investigation by firm
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).
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.
- 2026-04-06Open, ClassifiedIncorrect or no expiration date
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-06Open, ClassifiedIncorrect or no expiration date
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-06Open, ClassifiedIncorrect or no expiration date
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-06Open, ClassifiedIncorrect or no expiration date
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-06Open, ClassifiedIncorrect or no expiration date
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-06Open, ClassifiedIncorrect or no expiration date
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-06Open, ClassifiedIncorrect or no expiration date
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
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