Cook Endoscopy
Country not established
- Devices
- 4
- FDA recalls
- 16
At a glance
Market reach
- United States
- FDA recalls
What Cook Endoscopy makes
Cook Endoscopy manufactures endoscopic dilation balloons, including esophageal and wire-guided dilation devices, as well as an ultrasound-guided needle for procedural guidance. The company also produces a photodynamic therapy balloon with a fiber optic diffuser for targeted tissue treatment.
The portfolio includes Class II and Class III devices, with regulatory authorisation through FDA 510(k) clearances and PMA submissions. These products are listed under US regulatory frameworks and are based in the United States.
Catalogue
Cook Endoscopy Esophageal Dilation Balloon Ref K061937
Regimes: 510(k) Registry: 510(k)Echotip Ultra Ultrasound Needle Ref K083330
Regimes: 510(k) Registry: 510(k)Hercules 3 Stage Wire Guided Dilation Balloon Ref K090183
Regimes: 510(k) Registry: 510(k)- Regimes: PMA, withdrawn Registry: PMA
FDA recalls
FDA recall records list 16 recalls initiated by Cook Endoscopy, the earliest on 2006-01-05 and the most recent on 2011-06-07. By recorded status: 16 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 7 Jun 2011 Z-2691-2011 Unclassified (pre-2012) Terminated The disposable clip may not deploy after being positioned inside the patient.
2010
- 23 Dec 2010 Z-0925-2011 Unclassified (pre-2012) Terminated Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death.
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- 23 Dec 2010 Z-0926-2011 Unclassified (pre-2012) Terminated There is a risk of gastrointestinal perforation or air embolism due to balloon deflation difficulty, resulting in poor patient outcomes.
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- 3 Sep 2010 Z-0091-2011 Unclassified (pre-2012) Terminated A section of the ligator barrel may separate from the barrels friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator barrel detaching inside the patients gastrointestinal tract.
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- 3 Sep 2010 Z-0092-2011 Unclassified (pre-2012) Terminated A section of the ligator barrel may separate from the barrel's friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator barrel detaching inside the patient's gastrointestinal tract.
Full distribution text
- 23 Dec 2010 Z-0925-2011 Unclassified (pre-2012) Terminated Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death.
2009
- 24 Jul 2009 Z-1910-2009 Unclassified (pre-2012) Terminated The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
- 12 Jun 2009 Z-1598-2009 Unclassified (pre-2012) Terminated The wire control port of these devices may be missing due to omission of a manufacturing activity.
- 21 Jan 2009 Z-1059-2009 Unclassified (pre-2012) Terminated The snare head is hexagonal but the handle and packaging indicate an oval reorder number.
2008
- 30 Oct 2008 Z-0325-2009 Unclassified (pre-2012) Terminated The wire control port may have been omitted during manufacture.
- 11 Sep 2008 Z-0113-2009 Unclassified (pre-2012) Terminated A section of the introduction system may detach after the stent has deployed.
Show all 16 recalls
2008
- 2 Jul 2008 Z-2331-2008 Unclassified (pre-2012) Terminated The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.
- 2 Jul 2008 Z-2332-2008 Unclassified (pre-2012) Terminated It is possible the stents inside CLSO-10-10, lot W2512492 were 5cm in length, instead of 10cm in length as listed on the product packaging label.
2007
- 24 Jan 2007 Z-0520-2007 Unclassified (pre-2012) Terminated The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
2006
- 5 Oct 2006 Z-0160-2007 Unclassified (pre-2012) Terminated Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.
- 20 Apr 2006 Z-0848-06 Unclassified (pre-2012) Terminated Large product label contains an incorrect expiration date.
- 5 Jan 2006 Z-0441-06 Unclassified (pre-2012) Terminated The dilator size does not match the label on the product and product packaging.
Frequently asked questions
How many devices does Cook Endoscopy have in the registry?
The registry currently lists 4 devices for Cook Endoscopy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cook Endoscopy's devices?
Among its 4 most recently registered devices, Cook Endoscopy has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cook Endoscopy's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Cook Endoscopy's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Cook Endoscopy?
FDA recall records list 16 recalls initiated by Cook Endoscopy, the most recent initiated on 7 Jun 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Cook Endoscopy in the registry?
The most recently registered devices listed for Cook Endoscopy include COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON, ECHOTIP ULTRA ULTRASOUND NEEDLE, HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON and WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER.