EndoArmor™ Plus SGE-389-10Recalls & reported problems
Boston Scientific Corporation · EndoArmor Gown, Plus · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729989349), received between Mar 17, 2020 and Mar 17, 2020 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOARMOR GOWN WAS USED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, THE PHYSICIAN HAD A SKIN REACTION TO THE ENDOARMOR GOWN, INVOLVING A RASH FROM THE WRIST TO ELBOWS ON BOTH ARMS. REPORTEDLY, THE PHYSICIAN HAD PRE-EXISTING ALLERGIES. A STEROID CREAM WAS APPLIED AS AN IMMEDIATE TREATMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 9842087 ↗
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- MEDLINE NONTH150Medline Industries, Inc. · Non-surgical gown1 report
- CARDINAL HEALTH 2202CVCardinal Health 200, LLC · Non-surgical isolation gown1 report
- MEDLINE NONTH180Medline Industries, Inc. · Non-surgical gown1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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