MO.MA ULTRA MUS0130069X6 (UDI 08033477071909)Recalls & reported problems
Medtronic, Inc. · CATH MUS0130069X6 CPD ULTRA US 9F UL950 · Class 2
All models of MO.MA ULTRA (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033477071909), received between May 29, 2019 and May 29, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K092177); they may or may not involve this specific model.
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
- Deflation Problem1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2019Deflation Problem; Deflation Problem
IT WAS REPORTED THAT THE PHYSICIAN WAS USING A MOMA ULTRA DEVICE IN THE TREATMENT OF A PLAQUE LESION IN THE LEFT PROXIMAL COMMON CAROTID ARTERY(CCA). THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. THE PROXIMAL CCA BALLOON WOULD NOT COMPLETELY DEFLATE EVEN WITH 50/50 SALINE CONTRAST PEP. A 60CC SYRINGE OF NEGATIVE PRESSURE WAS NEEDED TO DEFLATE THE BALLOON. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8649607 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K092177. One submission often covers many models, so check the product and lot details in each record.
- Z-0320-2024 · Oct 12, 2023 · Open, ClassifiedMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
- Z-0321-2024 · Oct 12, 2023 · Open, ClassifiedMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
- Z-0322-2024 · Oct 12, 2023 · Open, ClassifiedMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
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- ENROUTE Transcarotid Neuroprotection System FG12531Boston Scientific Corporation · Temporary Carotid Catheter For Embolic Capture1 recall2 deaths137 reports
- EMBOSHIELD NAV6 22437-19Abbott Vascular Inc. · Temporary Carotid Catheter for Embolic Capture94 reports
- ANGIOGUARD 501814RMCCordis Corporation · Temporary Carotid Catheter For Embolic Capture1 recall14 reports
- ANGIOGUARD 601814RMCCordis Corporation · Temporary Carotid Catheter For Embolic Capture1 recall11 reports
- SpiderFX™ SPD2-US-060-320Ev3, Inc · Temporary Carotid Catheter for Embolic Capture1 death57 reports
- SpiderFX™ SPD2-US-050-320Ev3, Inc · Temporary Carotid Catheter for Embolic Capture56 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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