MO.MA ULTRARecalls & reported problems across all models

We found 3 models of MO.MA ULTRA by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Apr 29, 2021 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (8 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

MO.MA ULTRA recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 12, 2023Open, 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 MO.MA ULTRA problems

MO.MA ULTRA models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MO.MA ULTRA MUS0130069X6

  Temporary Carotid Catheter for Embolic Capture
  1 recall2 reports
• MO.MA ULTRA MUS0130069X6

  Temporary Carotid Catheter for Embolic Capture
  6 reports
• MO.MA ULTRA MUS0130069X6

  Temporary Carotid Catheter for Embolic Capture
  1 report

Recent MO.MA ULTRA adverse event reports

The 9 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗

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