Medtronic Recalls Cytosponge Cell Collection Kits Due to Detachment Reports
Medtronic is recalling Cytosponge Cell Collection Kits after two reports of the device detaching from the removal string during withdrawal from the esophagus.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device defect (detachment) that poses a significant risk of injury to patients during a procedure, meeting the criteria for a Severe rating.
Plain-English summary
Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device. The recall follows two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.
The affected product is the Cytosponge Cell Collection Kit, which contains the Cytosponge Cell Collection Device and a Specimen Jar with preservative. The device is indicated for use in the collection and retrieval of surface cells in the esophagus and is currently available only for clinical studies. The recall covers 620 total units, with distribution in the United States (Tennessee, North Carolina, Illinois, California, Minnesota, Oregon, and New York) and internationally in the United Kingdom and Iran. The specific lot numbers involved are 3441120915 and 3441102015.
Consumers and healthcare providers should stop using the recalled devices and contact Medtronic or their healthcare provider for further instructions.
The recalled product
- Product
- Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the…
- Manufacturer
- Covidien, LLC
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 (3)
- Item Code: CYTO-KIT-R
- Lot numbers: 3441120915
- 3441102015
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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