MO.MA ULTRA MUS0130069X6 (UDI 08033477090719)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477090719), received between Nov 19, 2020 and Apr 29, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Deflation Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Oct 12, 2023Class IIOpen, Classified

   The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.

   Z-0320-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  PHYSICIAN INTENDED TO USE A MO.MA ULTRA CEREBRAL PROTECTION DEVICE WITH A 9FR SHEATH AND 0.035 GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S DISTAL COMMON CAROTID ARTERY. SEVERE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. IFU WAS FOLLOWED. VESSEL PRE-DILATION WAS PERFORMED. IT IS REPORTED THE ECA BALLOON WOULD NOT DEFLATE FOLLOWING INFLATION IN THE CAROTID ARTERY. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE THE BALLOON UNSUCCESSFULLY. THE PHYSICIAN THEN DECIDED TO GENTLY REMOVE THE DEVICE WITH THE BALLOON STILL INFLATED AND ALL PORTS OPEN. WHEN THE BALLOON WAS REMOVED FROM THE PATIENT, THE BALLOON WAS DEFLATED. A REPLACEMENT MO.MA ULTRA DEVICE WAS SUCCESSFULLY USED, AND STENTING WAS PERFORMED. THERE WAS NO APPARENT INJURY AS A RESULT ALTHOUGH THE PATIENT DID SUFFER A STROKE AFTER REPLACING THE DEFECTIVE DEVICE AND DEPLOYING A CAROTID STENT. THE PHYSICIAN THOUGHT THE STROKE WAS A COMPLICATION OF THE PROCEDURE UNRELATED TO THE DEVICE FAILURE. NO FURTHER INJURY REPORTED.

  Patient problems: Ischemia Stroke

  MAUDE report 11745497 ↗
• InjuryNov 19, 2020Deflation Problem; Deflation Problem

  PHYSICIAN WAS ATTEMPTING TO USE A MO.MA DEVICE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE MID COMMON CAROTID ARTERY WITH 90% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL WAS PRE AND POST DILATED. IFU WAS FOLLOWED. THE COMMON CAROTID ARTERY BALLOON WOULD NOT DEFLATE. IT WAS REPORTED THAT PHYSICIAN CUT THE CATHETER AND EMPTIED THE CCA BALLOON. THE DEVICE WAS SUCCESSFULLY REMOVED AND THERE WAS NO PATIENT INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10866182 ↗

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-0322-2024 · Oct 12, 2023 · Open, Classified
  Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
• Z-0321-2024 · Oct 12, 2023 · Open, Classified
  Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6