MO.MA ULTRA MUS0130069X6 (UDI 08033477050140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08033477050140), received between Dec 2, 2016 and Apr 23, 2019 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (5 reports).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2019Deflation Problem; Deflation Problem

  THE PHYSICIAN WAS USING A MO.MA ULTRA TO TREAT 40MM SOFT TISSUE LESION WITH 95% STENOSIS IN THE PROXIMAL COMMON CAROTID ARTERY. ARTERY DIAMETER OF 9MM. THE BALLOON IN THE EXTERNAL CAROTID DEFLATED BUT THE BALLOON IN THE COMMON CAROTID ARTERY WOULD NOT DEFLATE DESPITE USING A 60CC SYRINGE AND AN ASPIRATION PUMP FROM A STRYKER THROMBECTOMY SYSTEM. NO INTERVENTION OR FOLLOW UP TREATMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8539595 ↗
• MalfunctionJul 25, 2018Burst Container or Vessel; Material Rupture; Burst Container or Vessel

  THE PHYSICIAN USED A MOMA ULTRA WITH A NON-MEDTRONIC 6FR SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 30 MM LESION IN THE PATIENT¿S MID RIGHT COMMON CAROTID ARTERY OF DIAMETER 8 MM. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED AND INFLATED DURING PREP WITHOUT ISSUE. IT IS REPORTED WHEN THE COMMON BALLOON WAS INFLATED PRIOR TO STENTING IT BURST. THE BALLOON BURST WHEN THE PHYSICIAN INFLATED WITH 8 CC OF THE CONTRAST/SALINE MIXTURE PER THE IFU. NO COMPONENT EMBOLISATION OCCURRED. A NEW MOMA DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7717421 ↗
• MalfunctionJul 3, 2018Deflation Problem; Deflation Problem

  THE PHYSICIAN USED A MO.MA ULTRA DEVICE DURING TREATMENT OF A 80% STENOSED CALCIFIED LESION IN THE PATIENTS PROXIMAL LEFT COMMON CAROTID ARTERY. MODERATE CALCIFICATION AND TORTUOSITY WERE REPORTED. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A 50/50 CONTRAST/SALINE WAS USED TO INFLATE THE BALLOON. IT IS REPORTED THE CCA BALLOON WOULD NOT DEFLATE VIA PORT DURING PROCEDURE TO MOVE THE MO.MA TO A MORE OCCLUSIVE POSITION. ATTEMPTS WERE MADE WITH MULTIPLE SYRINGES TO DEFLATE BUT DIDN¿T WORK. IT WAS OBSERVED THAT THE STUMP PRESSURE REMAINED WEDGE SHAPED. THE PHYSICIAN WIRED THE IC LESION AND DEPLOYED A 6MM SPIDER FX. THE IC LESION WAS PRE-DILATED WITH A 3MM RAPIDCROSS BALLOON AND A 10/7 PROTEGE RX WAS DEPLOYED ACROSS THE LESION. POST-DILATION WAS PERFORMED WITH A 4.5 X 15 CORONARY BALLOON. STUMP PRESSURE WAS EQUAL TO GROIN 9FR SHEATH PRESSURE AND UNDER FLUOROSCOPY IT WAS OBSERVED THE COMMON BALLOON HAD DEFLATED ON ITS OWN. THE PHYSICIAN PROCEEDED WITH POST ANGIOGRAPHY AND WAS COMFORTABLE THAT THE CASE WAS COMPLETED. THE DEVICES WERE REMOVED AND NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7657709 ↗
• InjuryMay 16, 2018Deflation Problem; Deflation Problem

  THE PHYSICIAN INTENDED TO USE A MO.MA. ULTRA DEVICE DURING THE TREATMENT OF A >90% STENOSED MODERATELY CALCIFIED SOFT TISSUE LESION IN THE MID COMMON CAROTID ARTERY. ABNORMALITIES REPORTED IN RELATION TO PATIENT ANATOMY ARE TYPE 2 ARCH, ICA LESION, ECA BRANCHES. THE DEVICE WAS INSPECTED AND PREPPED AS PER IFU WITHOUT ISSUE. A 50:50 INFLATION CONTRAST: SALINE WAS USED. IT IS REPORTED THE CCA BALLOON WOULD NOT DEFLATE. MULTIPLE ATTEMPTS WERE MADE, AND THE PHYSICIAN ATTEMPTED TO PUT A WIRE THROUGH THE BALLOON PORT TO LOOSEN THE VALVE IN ORDER TO RELEASE THE CONTRAST BUT THE WIRE WOULD NOT PASS THROUGH THE VALVE. THE PATIENT WAS EMBOLICALLY PROTECTED AS SEVERAL STRAIN FILTERS WERE FILLED WITH DEBRIS UNTIL CLEARED. THE BALLOON HAD TO BE REMOVED INFLATED. THE PATIENT POST PROCEDURAL NEUROLOGICAL TEST WAS PERFORMED, AND THE PATIENT PASSED ALL TESTS SHOWING HE WAS STABLE. IT WAS REPORTED THAT THE PATIENT IS DOING WELL WITH NO ADVERSE EVENTS FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7517652 ↗
• MalfunctionAug 16, 2017Deflation Problem; Deflation Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE ONE MOMA ULTRA DEVICE TO TREAT A LESION LOCATED IN THE LEFT DISTAL RELATIVELY STRAIGHT LCA. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE IFU WAS FOLLOWED. AFTER THE PHYSICIAN DEPLOYED A STENT SUCCESSFULLY, THE COMMON CAROTID BALLOON WAS SLOW DEFLATING. THE T-SAFETY WAS NOT USED AS THE BALLOON WAS INFLATED UNDER DIRECT VISUALIZATION. THE PHYSICIAN PULLED THE BALLOON BACK WHILE PARTIALLY INFLATED INTO THE ARCH OF THE VESSEL WHERE THE BALLOON WAS ABLE TO DEFLATE FULLY. THE BALLOON SALINE WAS ORIGINALLY MIXED 1 : 3 BUT THEY COULD NOT VISUALIZE THE BALLOON SO THIS WAS CHANGED TO A 1 : 2 MIXTURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6799187 ↗
• MalfunctionDec 2, 2016Deflation Problem; Deflation Problem

  PHYSICIAN WAS ATTEMPTING TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT CCA USING MOMA ULTRA OCCLUDING DEVICE. IT WAS REPORTED THAT THE CAROTID STENTING PROCEDURE COMPLETED WITH ASPIRATION X 3 CHECKED FOR DEBRIS NONE NOTED. ECA BALLOON DEFLATED 60 SECONDS, THEN WAITED FOR CCA BALLOON TO DEFLATE, CCA BALLOON DOES NOT DEFLATE SALES REP ASKED PHYSICIAN TO PUT RETRACTED PRESSURE ON CATHETER AND CCA BALLOON DEFLATES DOWN TO 2-3MM MOMA THEN RETRACTED OUT OF ECA ANGIOGRAPHY OF CAROTID AND CEREBRAL ARTERIES OBTAINED. VESSELS ARE PATENT AND NO ADVERSE EVENT NOTED WITHIN THE CCA MOMA THEN REMOVE THROUGH 9FR SHEATH POSSIBLY KINKED DURING PROCEDURE WAS NOT ABLE TO DETERMINE ANY KINK UNDER ANGIOGRAPHY PHYSICIAN REQUESTED MOMA BE EVALUATED ON WHY BALLOON DID NOT COMPLETELY DEFLATE. PROCEDURE WAS COMPLETED AND NO INJURY OCCURRED TO PATIENT AND PATIENT WAS DISCHARGED HOME WITH NO COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6141283 ↗

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, Classified
  Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
• Z-0321-2024 · Oct 12, 2023 · Open, Classified
  Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
• Z-0322-2024 · Oct 12, 2023 · Open, Classified
  Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5