Medtronic Recalls Cytosponge Cell Collection Device Due to Detachment Reports
Medtronic is recalling the Cytosponge Cell Collection Device after two reports of the device detaching from its removal string during withdrawal from the esophagus.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where the device detaches during use, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection Device, item code CYTO-101-01. The recall was initiated after two reports indicated that the device detached from the removal string during withdrawal from the patient's esophagus.
The affected device is indicated for the collection and retrieval of surface cells in the esophagus and is currently used only in clinical studies. A total of 620 units are involved in this recall, with 260 units distributed in the United States and 360 units distributed outside the US. US distribution included Tennessee, North Carolina, Illinois, California, Minnesota, Oregon, and New York, while international distribution included the United Kingdom and Iran. The specific lot numbers involved are F2500566X, F2500628X, F2500202X, and F2500351X.
This recall is classified as Class II by the FDA. Users of the device should contact Medtronic or their clinical study coordinator for further instructions regarding the recall and proper handling of the affected units.
The recalled product
- Product
- Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
- Manufacturer
- Covidien, LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Item Code: CYTO-101-01. Lot numbers: F2500566X
- F2500628X
- F2500202X
- F2500351X.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Covidien, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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