MANTA IPN930507Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10841156111335), received between Nov 5, 2025 and Sep 16, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (4 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Patient-Device Incompatibility; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 50788235 ↗
• InjuryApr 30, 2026Insufficient Device Problem Information; Failure to Seal

  IT WAS REPORTED THAT DURING A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE, THE MANTA 18F VASCULAR CLOSURE DEVICE FAILED TO ACHIEVE CLOSURE OF THE RIGHT FEMORAL ARTERY. A SURGICAL CUTDOWN WAS SUBSEQUENTLY PERFORMED TO CLOSE THE ARTERIOTOMY. GOOD-FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE AND TO ASSESS WHETHER ANY PATIENT HARM, INJURY, OR ADVERSE HEALTH CONSEQUENCES OCCURRED; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE USER HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 25045094 ↗
• InjuryApr 8, 2026Failure to Seal

  IT WAS REPORTED THAT: "SURGEON DEPLOYED MANTA AND FOUND THERE WAS EXCESSIVE BLEEDING. CUTDOWN PERFORMED TO REMOVE MANTA AND REPAIR ARTERY."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24813145 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: "CONTINUED BLEEDING FROM SITE. ANGIOGRAM REVEALED POSSIBLE DISSECTION NEAR THE ACCESS (ARTERIOTOMY). COVERED STENT PLACED. NO OTHER HARM TO THE PATIENT."

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 24696801 ↗
• InjuryMar 6, 2026Obstruction of Flow

  IT WAS REPORTED THAT: "MANTA 18FR WAS USED POST TAVR VALVE WITH GOOD RESULT AND POST IMAGE. 7 DAYS LATER PT PRESENTED WITH FEMORAL OCCLUSION REQUIRING SURGICAL INTERVENTION TO RESTORE FLOW. MANAGER REPORTED THAT SURGICAL CONSULTANT SAID IT WAS A PLAQUE SHIFT IN THE ARTERY LIKELY NOT FROM THE MANTA ITSELF. OCCLUSION LOCATION WAS NOT IDENTIFIED. THE MANTA LOOKED LIKE IT WAS IN THE PROPER POSITION. THERE WAS DISTAL FLOW AND NO EXTRAVASATION."

  Patient problems: Obstruction/Occlusion

  MAUDE report 24531602 ↗
• MalfunctionMar 6, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT " PHYSICIAN MET SEVERE RESISTANCE ATTEMPTING TO ADVANCE MANTA DEVICE THROUGH MANTA SHEATH POST TAVR PROCEDURE. PHYSICIAN REMOVED THE MANTA DEVICE FROM OVER THE WIRE UNDEPLOYED AND REMOVED THE MANTA SHEATH. A SECOND MANTA SHEATH WAS ADVANCED AND SUCCESSFULLY CLOSED WITH SECOND MANTA DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530789 ↗
• InjuryJan 21, 2026Failure to Seal

  IT WAS REPORTED THAT: "DURING A TEVAR PROCEDURE, AN 18 FR MANTA WAS DEPLOYED IN RT FEMORAL ARTERY BUT FAILED TO CLOSE. DR. (B)(6) HELD PRESSURE FOR 10MINUTES, PREFORMED DOPPLER STUDY TO CONFIRM LACK OF BLOOD FLOW PAST THE CLOSURE SITE. A SUCCESSFUL CUT DOWN PROCEDURE WAS PREFORMED TO CLOSE ARTERY & REMOVE ANCHOR AND COLLAGEN. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 24128645 ↗
• InjuryJan 9, 2026Failure to Seal

  IT WAS REPORTED THAT "DURING AN EVAR. BLEEDING ON THE SURFACE AFTER MANTA DEPLOYMENT. CUTDOWN PERFORMED WITH EXPLANT OF MANTA. MANTA FOOTPLATE WAS STUCK IN SMALL SIDE BRANCH NOT APPRECIATED DURING U/S. COLLAGEN WAS PUSHED IN THE VESSEL CAUSING OCCLUSION OF CFA. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017760 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "DR. (B)(6) DEPLOYED A 18F MANTA PER IFU SPECKS POST TVAR. DURING THE PROCEDURE THERE WAS A NOTED ISSUE WITH THE VALVE, A SECOND ONE NEEDED TO BE USED. WHEN AN ANGIOGRAM WAS TAKEN, WE NOTICED A LARGE BLUSH. A COVERED STENT WAS NEEDED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Extravasation

  MAUDE report 23987601 ↗
• InjuryJan 7, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT: "CUSTOMER REPORTED A POST TAVR MANTA CLOSURE PATIENT FROM (B)(6) 2025 RETURNED TO THE ER. WITH A COLD LEG ON (B)(6) 2025. INITIAL CLOSURE WAS SUCCESSFUL AND DISCHARGED (B)(6) 2025 WITH SITE IN GOOD CONDITION WITH NO EVIDENCE OF VASCULAR ISSUES. CUSTOMER REPORTED THAT THE MANTA FOOT PLATE HAD MIGRATED. OPEN PROCEDURE DONE TO REMOVE THE FOREIGN BODY FROM THE RIGHT POPLITEAL. CT SCAN DEMONSTRATES NO CALCIUM OR STENOSIS AT THE ACCESS SITE. PATIENT DISCHARGED ON (B)(6) 2025 IN GOOD CONDITION."

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 23987513 ↗
• InjuryDec 29, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT: "DURING A TAVR PROCEDURE, BLEEDING NOTED FOLLOWING A MANTA DEPLOYMENT. POST ANGIOGRAM REVEALED MANTA DEPLOYED IN THE TISSUE TRACT. SURGICAL REMOVAL OF MANTA CONFIRMED THE DEVICE WAS NOT IN THE VESSEL. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23904473 ↗
• InjuryDec 24, 2025Break; Break

  IT WAS REPORTED THAT: "DID A AAA CASE WITH DR (B)(6), DURING CLOSURE TWO MANTA'S WERE DEPLOYED. THE 14 FR MANTA WAS DEPLOYED ON THE LEFT SIDE WITH NO INCIDENT. DURING THE DEPLOYMENT OF THE 18FR MANTA ON THE RIGHT-SIDE DR (B)(6) PULLED TO TENSION AND THE SUTURE BROKE. DR (B)(6) PREFORMED A SURGICAL CUTDOWN TO CLOSE THE GROIN HE WAS ABLE REPAIR ARTERY AND PT HAD GOOD DISTAL PULSES AFTER REPAIR." .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886821 ↗
• InjuryDec 23, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT: "CONTINUED BLEEDING FROM ACCESS SITE POST MANTA DEVICE DEPLOYMENT. ANGIOGRAM REVEALED EXTRAVASATION FROM THE ACCESS SITE. 2 OVERLAPPING COVERED STENTS WE PLACED ACROSS THE ACCESS SITE AND MANUAL PRESSURE WAS HELD FOR 30 MINUTES POST PROCEDURE".

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23876975 ↗
• InjuryDec 3, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT "DOCTOR DEPLOYED MANTA IN A VESSEL WITH MILD POSTERIOR CALCIUM THAT WAS 7MM IN SIZE. THE FOOT PLATE CAUGHT ON THE CALCIUM AND DEPLOYED THE COLLAGEN INSIDE THE FEMORAL ARTERY". ADDITIONAL INFORMATION RECEIVED STATES THAT A SURGICAL CUTDOWN WAS PERFORMED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708444 ↗
• InjuryDec 3, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "AFTER THE TAVR PROCEDURE THE PHYSICIAN WENT TO DEPLOY MANTA, AND PERFORMED DEPLOYMENT STEPS PROPERLY, THE DEVICE WAS DEPLOYED AND NO BLOOD WAS PRESENT AT THE SKIN LEVEL. A DSA WAS TAKEN TO SHOW THERE WAS A PARTIAL BLOCKAGE OF THE VESSEL , WITH LIMITED FLOW DISTALLY. IT WAS THE OPINION OF THE VASCULAR SURGEON TO CUT DOWN. THE CARDIOLOGIST WAS UNABLE TO TRY AND REMEDY THE SITUATION WITH ANY OTHER STEPS. A CUT DOWN WAS PERFORMED AND WHEN THE VS WAS PERFORMING THE CUT DOWN, DOPPLER PULSES WERE PRESENT DISTAL TO THE MANTA. THE MANTA WAS EXPLANTED. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 23704810 ↗
• InjuryDec 3, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT "DURING A CABG REPAIR W/ 20F CANNULATION THROUGH THE RIGHT CFA, WITH A VESSELS SIZE OF 8+MM, THE MANTA WAS DEPLOYED IN VESSE. A SURGICAL CUT DOWN WAS PERFORMED TO COMPLETE THE PROCEDURE AND THE PATIENT WAS REPORTED AS FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704451 ↗
• MalfunctionNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: " DURING A TAVR PROCEDURE ULTRASOUND AND MICROPUNCTURE WERE UTILIZED TO GAIN CENTRAL ACCESS IN THE LEFT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 6.5MM WITH NO REPORTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 2+1CM. POST DEPLOYMENT, DISSECTION AT MANTA SITE- BALLOONED TO RESTORE FLOW. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Vascular Dissection

  MAUDE report 23476271 ↗
• MalfunctionNov 5, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "DURING A TAVR PROCEDURE, MICROPUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN LOWER ACCESS IN THE RIGHT COMMON F EMORAL ARTERY. VESSEL SIZE WAS 7.5MM WITH NO REPORTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 2.5CM +1. THERE WAS NO BLOOD FLOW POST DEPLOYMENT. BALLOONED FEMORAL ARTERY WITH 7 X 40 BALLOON WITH FLOW RESTORED. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 23475921 ↗