Cook Ireland Ltd
FDA adverse event reports naming Cook Ireland Ltd as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: COOK IRELAND LTD.
- Total reports
- 9,121
- Deaths
- 24
- Injuries
- 3,342
- Malfunctions
- 5,751
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
- Stents, Drains And Dilators For The Biliary DuctsFGE3,837
- Biopsy NeedleFCG1,766
- Stent, Superficial Femoral Artery, Drug-ElutingNIU1,400
- Stent, IliacNIO445
- Prosthesis, EsophagealESW388
- Stent, UreteralFAD282
- Stent, Iliac VeinQAN240
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS202
- Stent, Metallic, Expandable, DuodenalMUM201
- Stent, Colonic, Metallic, ExpandableMQR155
Recent recalls
- 2012-09-01TerminatedPackaging process control
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35
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