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Terminated

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.

FDA Recall Z-2123-2016 · Posted None

Recalling FirmCovidien, LLC
Recall StatusTerminated
Product CodeEOX
Date Initiated2016-06-06
Date Terminated2017-10-18
Product Quantity620 total units (260 US; 360 OUS)

Reason for Recall

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.

Firm 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 [email protected] 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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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