NA SVT-089Recalls & reported problems
Boston Scientific Corporation · Suction Tubing · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840253111999), received between Mar 31, 2020 and Oct 19, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).
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.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2020Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SUCTION TUBING WAS TO BE USED ON A COLONOSCOPY PROCEDURE, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING SET UP, A HARD, DARK SOLID MATERIAL WAS FOUND STUCK IN THE TUBING. ANOTHER COMPLIANCE KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10697807 ↗MalfunctionMar 31, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SUCTION TUBING WAS TO BE USED ON A COLONOSCOPY WITH ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A FOREIGN BODY NOTICED INSIDE OF TUBING. THE PROCEDURE WAS COMPLETED WITH ANOTHER SUCTION TUBING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9902549 ↗
Other TUBING, NONINVASIVE devices
- Argyle 8888301614Cardinal Health, Inc. · TUBING, NONINVASIVE14 reports
- Argyle 8888301713Cardinal Health, Inc. · TUBING, NONINVASIVE11 reports
- Argyle 8888301523Cardinal Health, Inc. · TUBING, NONINVASIVE3 reports
- Argyle 5558301627Cardinal Health, Inc. · TUBING, NONINVASIVE3 reports
- MEDLINE DYND50252Medline Industries, Inc. · TUBING, NONINVASIVE3 reports
- MEDLINE DYND50251Medline Industries, Inc. · TUBING, NONINVASIVE2 reports
- Argyle 8888301606Cardinal Health, Inc. · TUBING, NONINVASIVE2 reports
- Argyle 8888301507Cardinal Health, Inc. · TUBING, NONINVASIVE1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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