MyoSure Tissue Removal Device 40-902Recalls & reported problems
Hologic, Inc. · MyoSure Single Use Seals are an accessory to the Hologic Hysteroscopes and are used to prevent distension fluid leakage from the proximal ends of hysteroscope and removable outflow channel. · Class 2
All models of MyoSure Tissue Removal Device (4)
Data updated Oct 18, 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 25420045505107), received between Mar 3, 2026 and Mar 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Material Puncture/Hole1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Material Puncture/Hole
IT WAS REPORTED THAT DURING A MYOSURE/OMNI PROCEDURE ON (B)(6) 2026, THE PHYSICIAN WAS USING AN OMNI SCOPE FOR HYSTEROSCOPY AND BEGAN A MYOSURE PROCEDURE USING A REACH DEVICE. AFTER INSERTING THE MYOSURE REACH THROUGH THE SCOPE THE PHYSICIAN VISUALIZED WHAT WAS BELIEVE TO BE A PIECE OF PLASTIC ON THE DISTAL END OF THE MYOSURE DEVICE. THE DEVICE HAD NOT BEEN ACTIVATED AFTER BEING INSERTED INTO THE SCOPE AND THE MATERIAL WAS SEEN BEFORE ANY USE OF THE DEVICE IN THE PATIENT. THE PHYSICIAN REMOVED THE SCOPE FROM THE PATIENT AND THE TECH REMOVED THE PIECE FROM THE END OF THE DEVICE. THE PIECE WAS REPORTED AS APPEARED A PIECE OF THE SCOPE SEAL FROM THE END OF THE SCOPE. STAFF REPORTED THAT THERE WAS NO MATERIAL OBSERVED ON THE END OF THE DEVICE PRIOR TO INSERTION INTO THE PATIENT. THE MATERIAL WAS DISCARDED AND THE PHYSICIAN CONTINUED THE PROCEDURE WITHOUT OBSERVING ANY ADDITIONAL MATERIAL IN THE UTERUS. THE PHYSICIAN REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY REPORTED AND NO MEDICAL INTERVENTION REQUIRED. STAFF EXAMINED THE SCOPE SEAL AT THE END OF THE PROCEDURE AND DETERMINED THAT IT DID APPEAR AS A PIECE OF THE SEAL HAD BEEN BROKEN OFF. CUSTOMER WAS UNAB
Patient problems: Foreign Body In Patient
MAUDE report 24501158 ↗
Other HYSTEROSCOPE (AND ACCESSORIES) devices
- Olympus WA2T430AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)783 reports
- Olympus WA2T412AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)453 reports
- Olympus A22001AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)366 reports
- Olympus WA2T470AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)323 reports
- Olympus A22002AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)297 reports
- Olympus A22003AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)198 reports
- n.a. 27040XAKarl Storz GmbH & Co. KG · HYSTEROSCOPE (AND ACCESSORIES)102 reports
- Myosure Reach Tissue Removal Device 10-401FCHologic, Inc. · HYSTEROSCOPE (AND ACCESSORIES)4 deaths99 reports
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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