ESP™ M001201120Recalls & reported problems
Boston Scientific Corporation · Radiation Reduction Examination Gloves · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729735175), received between Nov 15, 2018 and Nov 16, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Defective Device” (3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Defective Device3
Patient problems
- No Patient Involvement3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2018Defective Device; Defective Device
IT WAS REPORTED THAT SEVERAL PAIRS OF SIZE 8 ESP SPECIALTY GLOVES HAD BEEN OPENED AND EVERY PAIR HAD A HOLE IN THE WRIST. THERE WERE NO PATIENT OR PHYSICIAN INJURIES OR ISSUES REPORTED TO HAVE OCCURRED.
Patient problems: No Patient Involvement
MAUDE report 8080117 ↗MalfunctionNov 16, 2018Defective Device; Defective Device
IT WAS REPORTED THAT SEVERAL PAIRS OF SIZE 8 ESP SPECIALTY GLOVES HAD BEEN OPENED AND EVERY PAIR HAD A HOLE IN THE WRIST. THERE WERE NO PATIENT OR PHYSICIAN INJURIES OR ISSUES REPORTED TO HAVE OCCURRED.
Patient problems: No Patient Involvement
MAUDE report 8080099 ↗MalfunctionNov 15, 2018Defective Device; Defective Device
IT WAS REPORTED THAT SEVERAL PAIRS OF SIZE 8 ESP SPECIALTY GLOVES HAD BEEN OPENED AND EVERY PAIR HAD A HOLE IN THE WRIST. THERE WERE NO PATIENT OR PHYSICIAN INJURIES OR ISSUES REPORTED TO HAVE OCCURRED.
Patient problems: No Patient Involvement
MAUDE report 8074273 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.