Cytosponge CYTO-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884521767789), received between Oct 6, 2020 and Jun 22, 2023 — classified as 14 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 2, 2023Class IIOpen, Classified

   Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.

   Z-2282-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE WAS ADMINISTERED WITHOUT ANY CONCERNS. PATIENT SWALLOWED THE DEVICE WITH EASE, COMFORTABLE WHILE WAITING FOR THE SPONGE TO EXPAND. REMOVAL OF THE DEVICE APPEARED AS NORMAL AND STEADY OVER COUPLE OF SECONDS. HOWEVER RIGHT AT THE END OF REMOVAL, PATIENT GAGED AND THEN STRING COME OUT STILL WITH A LITTLE KNOT AT THE END AND NO SPONGE PRESENT. PATIENT WAS GIVEN AN ENDOSCOPY PROCEDURE TO REMOVE THE SPONGE WITHIN 30 MINUTES AFTER IT WAS SWALLOWED. THE SPONGE WAS RETRIEVED FROM THE ESOPHAGUS AND IT WAS LOCATED RIGHT AT THE TOP OF GASTRO ESOPHAGEAL JUNCTION. THE PATIENT WAS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17183395 ↗
• InjuryJun 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CYTOSPONGE PROCEDURE, WHILE REMOVING THE DEVICE FROM THE PATIENT, THE SUTURE DETACHED FORM THE CYTOSPONGE. AN ENDOSCOPY WAS PERFORMED TO REMOVE THE CYTOSPONGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 17156837 ↗
• InjuryJun 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CYTOSPONGE DETACHED FROM STRING UPON RETRIEVAL. THE NURSE FELT THAT IT BROKE AT THE TOP OF THE ESOPHAGUS. ENDOSCOPY WAS REQUIRED TO RETRIEVE SPONGE, RETRIEVAL ENDOSCOPY WAS PERFORMED WITHIN 5 MINUTES, AND IT WAS RETRIEVED WITH NO ISSUES WITHIN 4 HOURS. THE PATIENT WAS PREPPED FOR THE PROCEDURE. THE SPONGE WAS AT 20 CENTIMETER AT THE TOP OF THE ESOPHAGUS WHEN THEY REPORTED THAT THE STRING SNAPPED. THE CUSTOMER WAS CONFIDENT THE SPONGE REACHED THE STOMACH AS TENSION WAS FELT ON THE FIRST PULL. THERE WERE NO PROBLEMS WITH THE PATIENT, NO PREVIOUS SURGERY TO THE STOMACH OR ESOPHAGUS. THERE WERE NO ABNORMALITIES NOTICED DURING THE RETRIEVAL ENDOSCOPY, AND THE GASTROINTENSTINAL TRACT WAS NORMAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 17093245 ↗
• InjuryJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CYTOSPONGE PROCEDURE FOR BARRETT¿S ESOPHAGUS, THE SPONGE DETACHED FROM END OF STRING AS IT WAS BEING PULLED OUT OF ESOPHAGUS. ENDOSCOPY WAS DONE TO RETRIEVE THE SPONGE AND IT WAS RETRIEVED FROM PYLORUS. THE PATIENT HAD TO EXTEND HOSPITALIZATION FOR A FEW HOURS. THE PATIENT WAS PREPPED FOR THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17058667 ↗
• InjuryJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, NORMAL PROCEDURE WAS DONE, AND THE PATIENT WAS VERY CALM AND COMPLIANT. THERE WERE NO SWALLOWING DIFFICULTIES TO THE PATIENT. THERE WAS NOTHING UNUSUAL ABOUT THE PROCEDURE UNTIL THE POINT OF DETACHMENT. WHEN REMOVING THE SPONGE, THE SPONGE SNAPPED WITH A POP SOUND. THERE WAS INITIALLY TENSION ON THE STRING AND THEN IT WENT COMPLETELY LAX. THE SPONGE WAS REMOVED ENDOSCOPICALLY WITHIN TWO HOURS AND WAS RETRIEVED FROM THE STOMACH, NEAR THE PYLORUS, AND THERE WAS NO SEDATION GIVEN. THE STRING WAS NOT RETAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17058193 ↗
• InjuryJun 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CYTOSPONGE PROCEDURE, THE CYTOSPONGE DETACHED FROM THE STRING DURING THE PERIOD OF REMOVAL FROM ESOPHAGUS. THERE WAS NO ISSUE SWALLOWING DEVICE, AND THE CUSTOMER WAS CONFIDENT THAT DEVICE HAD REACHED STOMACH. THERE WAS NO TENSION FELT ON THE STRING. THE PATIENT WAS TAKEN FOR ENDOSCOPY AND THE DEVICE WAS RETRIEVED AT THE GASTROESOPHAGEAL JUNCTION. THE PATIENT HAD TO STAY IN HOSPITAL 4 TO 6 HOURS LONGER TO UNDERGO ENDOSCOPY. THE PATIENT WAS OKAY AFTER THE ENDOSCOPY PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17043690 ↗
• InjuryJun 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CYTOSPONGE PROCEDURE ON THE PATIENT'S 12 MONTH FOLLOW-UP, THE PATIENT SWALLOWED THE DEVICE WHICH WAS UNDER LOCAL ANESTHESIA, UPON RETRIEVAL, THE DEVICE DETACHED FROM THE STRING. THERE WAS NO ISSUE SWALLOWING THE DEVICE, AND THE CUSTOMER WAS CONFIDENT THAT DEVICE HAD REACHED STOMACH. THERE WAS NO TENSION FELT ON THE STRING AND THERE WERE NO ISSUES ON BASELINE CYTOSPONGE PROCEDURE. THE PATIENT WAS TAKEN FOR ENDOSCOPY TO WHICH THE PATIENT WAS UNDER SEDATION TO RETRIEVE THE DEVICE, AND IT WAS RETRIEVED FROM 29 CENTIMETERS. THE PATIENT HAD TO STAY IN HOSPITAL 4 TO 6 HOURS WHILE THEY HAD THEIR ENDOSCOPY. THE PATIENT WAS OKAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17043571 ↗
• InjuryMay 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SPONGE LOOKED FINE PRIOR PLACEMENT. THE STRING DIDN'T SNAP, NO SWALLOW DIFFICULTIES AND THE CAPSULE WENT OVER EASILY. HOWEVER, UPON REMOVAL OF THE SPONGE, STRING DETACHED FROM THE SPONGE. IT SNAPPED OFF AS IT WAS BEING BROUGHT OVER THE BACK OF THE THROAT. ADEQUATE TENSION WAS FELT FULL LENGTH OF ESOPHAGUS AND THEN IT ¿PINGED¿ AS THE SPONGE REACHED THE BACK OF THE THROAT. PATIENT HAD TO UNDERGO AN ENDOSCOPY TO RETRIEVE THE SPONGE SO HAD TO STAY ON FOR A FEW HOURS. THE SPONGE WAS RETRIEVED WITHIN 30 MINUTES, IT WAS SITTING AT THE TOP OF THE STOMACH. NO PREVIOUS SURGERY WAS DONE TO THE PATIENT. A REPEAT PROCEDURE WAS NEEDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16930135 ↗
• InjuryApr 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SPONGE DETACHED FROM STRING UPON RETRIEVAL. THE CUSTOMER FELT THAT IT BROKE AT THE GASTRO ESOPHAGEAL JUNCTION. ENDOSCOPY WAS REQUIRED TO RETRIEVE THE SPONGE. SPONGE WAS RETRIEVED WITHIN FOUR HOURS FROM THE STOMACH NEAR THE PYLORUS, CUSTOMER TRIED TO CAPTURE WITH ROTH NET AS PER INSTRUCTIONS FOR USE (IFU), BUT COULDN'T CAPTURE IT SO ENDED UP USING A SNARE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 16837803 ↗
• InjuryJan 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, A PATIENT WITH THE HISTORY OF MILD DIFFICULTIES OF DYSPHAGIA, DURING THE CYTOSPONGE PROCEDURE, THE NURSE TRIED TO RETRIEVE THE SPONGE BY PULLING ON THE STRING. THE SPONGE HAD DETACHED FROM THE STRING WHICH WAS LOCATED 30 CM FROM THE MOUTH NOT FAR FROM THE GASTROESOPHAGEAL JUNCTION . ENDOSCOPY WAS PERFORMED IN A HOSPITAL WITHIN 4 HOURS OF PROCEDURE TO RETRIEVE THE DEVICES. THE PATIENT WAS PREPPED FOR THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16272456 ↗
• InjuryJan 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE STRING OF THE DEVICE WAS DETACHED WHEN BEING WITHDRAWN FROM THE PATIENT. THEY WERE PLANNING TO PERFORM BARRETT'S ESOPHAGUS. THE SPONGE WAS RETRIEVED FROM MID OESOPHAGUS VIA ENDOSCOPY. THERE WAS BREAKAGE IN STRING AND SPONGE CONNECTION. THE STRING WAS INTACT WITH FRAGMENT OF SPONGE ATTACHED TO END KNOT. THE SPONGE WAS INTACT PRIOR USE AND ADEQUATE TENSION WAS FELT ON THE STRING.

  Patient problems: Foreign Body In Patient

  MAUDE report 16255214 ↗
• InjuryJan 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CYTOSPONGE PROCEDURE FOR BARRETT'S ESOPHAGUS, UPON REMOVAL OF THE SPONGE, THE SPONGE DETACHED FROM THE STRING. THE PATIENT WAS PREPPED BEFORE THE PROCEDURE. THE PATIENT REQUIRED ENDOSCOPY TO RETRIEVE THE SPONGE. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16097079 ↗
• InjuryDec 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SPONGE TENSION WAS FELT AS NORMAL AND JUST BEFORE REMOVAL HIGH UP THE TENSION RELEASED AND THE SPONGE DETACHED FROM THE STRING DURING THE CYTOSPONGE PROCEDURE. THEY WERE PLANNING TO PERFORM BARRETT'S ESOPHAGUS. THE SPONGE WAS RETRIEVED VIA ENDOSCOPY AND PATIENT ESOPHAGUS APPEARED SLIGHTLY STRICTURED. A REPEAT PROCEDURE WAS NEEDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16025272 ↗
• InjuryOct 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE CAPSULE WAS SWALLOWED NORMALLY AND WAS LEFT TO DISSOLVE FOR 7 MINUTES AND 30 SECONDS AS PER THE PROTOCOL. UPON RETRIEVAL, IT SEEMED NORMAL UNTIL THERE WAS A COMPLETE LOSS OF TENSION AND THE STRING WAS REMOVED BUT THE SPONGE WAS LEFT IN THE ESOPHAGUS. THE PROCEDURE THAT THEY WERE DOING WAS BARRETT¿S SURVEILLANCE. THE PATIENT WAS BOOKED FOR ENDOSCOPY AND A GASTROSCOPY WAS DONE TO RETRIEVE THE SPONGE WHICH WAS DONE WITH NO COMPLICATIONS. THE SPONGE WAS SENT FOR PATHOLOGY. THE PATIENT WAS NOT UNDER ANESTHESIA AND NO REPEAT PROCEDURE WAS NEEDED.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10639757 ↗