FDA Medical Device Recalls (openFDA)
Covidien, LLC: 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.
- Recall number
- Z-2123-2016
- Recalling firm
- Covidien, LLC
- 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.
- Status
- Terminated
- Initiated
- 2016-06-06
- Posted
- not on file
- Terminated
- 2017-10-18
- Reason
- Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.
- Root cause
- Process control
- Action
- The firm, Medtronic, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 6, 2016 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and discontinue use; return affected product to Medtronic/Covidien, Quality Department, 540 Oakmead Parkway, Sunnyvale CA 94085; complete and return the RECALLED PRODUCT RETURN FORM by email to Customer Service feedback.customerservice@Covidien or fax to (800)-895-6140 if product purchased directly from Medtronic; or by email to Quality Compliance MITGFCA@Covidien.com or fax to (203) 492-7719 if Product purchased through distributor or you have "no inventory"; and to promptly alert any other person or facilities if they have further distributed the product. All affected lots must be returned. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at (800) 882-5878.
- Quantity
- 620 total units (260 US; 360 OUS)
- Distribution
- Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.
- Lot, serial or model codes
- Item Code: CYTO-101-01. Lot numbers: F2500566X, F2500628X, F2500202X, F2500351X.
- 510(k) numbers
- ["K152794"]
- PMA numbers
- not on file
- Product code
- EOX
- Firm FEI
- 3004904811
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28