MANTA IPN930509Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10841156111359), received between Dec 1, 2025 and Sep 2, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 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.

• InjurySep 2, 2026Malposition of Device

  Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50555490 ↗
• MalfunctionMay 5, 2026Material Puncture/Hole; Physical Resistance/Sticking

  IT WAS REPORTED THAT, "THE FIRST 14F MANTA DEVICE WAS PARTIALLY INSERTED INTO THE SHEATH, AT WHICH POINT RESISTANCE WAS ENCOUNTERED. IT WAS OBSERVED THAT THE FOOTPLATE WAS EXPOSED OUTSIDE OF THE BYPASS TUBE. A SECOND 14F MANTA DEVICE WAS SUBSEQUENTLY OPENED, AND THE OPERATOR UTILIZED THE EXISTING FIRST MANTA SHEATH FOR INSERTION. THE SAME ISSUE OCCURRED, WITH RESISTANCE ENCOUNTERED DURING INSERTION AND THE FOOTPLATE AGAIN OBSERVED TO BE EXPOSED OUTSIDE OF THE BYPASS TUBE. THE ENTIRE MANTA SYSTEM WAS THEN REMOVED FROM THE GUIDEWIRE, AT WHICH TIME A HOLE WAS IDENTIFIED IN THE FIRST MANTA SHEATH. A THIRD 14F MANTA DEVICE WAS OPENED AND SUCCESSFULLY DEPLOYED WITHOUT FURTHER ISSUE." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083258 ↗
• InjuryFeb 26, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THE IMPELLA SHEATH WAS REMOVED AND THE DEPTH WAS MEASURED WITH A 14 FR DEPTH LOCATOR THAT MEASURED "7". THE MANTA SHEATH AND INTRODUCER WAS PREPPED AND THE MANTA SHEATH WAS ADVANCED WITH NO RESISTANCE. THE FIRST MANTA DEVICE WAS REMOVED UNDEPLOYED AS RESISTANCE WAS EXPERIENCED. A SECOND MANTA SHEATH WAS ADVANCED MEETING NO RESISTANCE AND WAS ADVANCED OVER THE WIRE AND DEPLOYED AT 8. POST MANTA DEPLOYMENT, THE PATIENT HAD NO PEDAL PULSES FOUND VIA DOPPLER. ACCESS WAS ACHIEVED CONTRALATERAL. A PIGTAIL CATHETER WAS ADVANCED AND ANGIO WAS TAKEN WHICH SHOWED OCCLUSION PROXIMAL TO CFA. THE PATIENT WAS THEN SENT TO SURGERY. PER THE SURGEON OPERATIVE REPORT, "A SUTURE WAS IDENTIFIED ALONG WITH A COLLAGEN PLUG AND FOOTPLATE WITHIN THE VESSEL. THIS WAS REMOVED. A FOGARTY CATHETER WAS THEN ATTEMPTED TO PERFORM EMBOLECTOMY HOWEVER WE HAD DIFFICULTIES PASSING THE CATHETER PROXIMALLY. THE ARTERIOTOMY WAS THEN EXTENDED WITH A POTTS SCISSORS. A RUBBER PLUG WAS IDENTIFIED MORE PROXIMALLY IN THE COMMON FEMORAL ARTERY AND THIS WAS REMOVED." THE "RUBBER PLUG" WAS SENT TO PATHOLOGY. THE PATIENT RECEIVED 2 UNITS OF BLOOD ON (B)(6). 1 UNIT ON (B)(6) AND 1 UNIT ON (B)(6). THIS WAS T

  Patient problems: Obstruction/Occlusion

  MAUDE report 24452503 ↗
• MalfunctionFeb 20, 2026Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT " THE MAIN ISSUE WAS THE BYPASS TUBE. IT WAS VERY DIFFICULT TO ADVANCE INTO THE VALVE OF THE SHEATH, IT WOULD NOT GO AT ALL. THE PHYSICIAN LEFT THE EXISTING SHEATH IN THE BODY AND PULLED A NEW CLOSURE UNIT AND DEPLOYED THAT INTO THE EXISTING SHEATH WITH MUCH BETTER EASE. IT WAS NOT SMOOTH BUT EASIER THAN THE FIRST CLOSURE UNIT. THERE WAS NO HARM TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400225 ↗
• MalfunctionDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: "CONTINUED BLEEDING FROM SITE POST PROCEDURE. ANGIOGRAM REVEALED NO EXTRAVASATION. 8.0 X 40MM PERIPHERAL BALLOON INFLATED ACROSS ACCESS SITE AND PROXIMAL(ILLIAC), WITH NO EFFECT ON THE BLEEDING. PHYSICIAN BELIEVES THAT MANTA LIKELY DEPLOYED CORRECTLY, AND THAT THE BLEEDING WAS POSSIBLY FROM INCIDENTAL VENOUS DAMAGE INSTEAD." ADDITIONAL INFORMATION: "OPERATING INTERVENTIONAL CARDIOLOGIST STATED THAT: THE ARTERY WAS INTACT, AND THE MANTA DEVICE WAS POSITIONED CORRECTLY IN THE VESSEL. THE IC REPORTED THAT THE BLEEDING WAS VENOUS WHICH COULD HAVE OCCURRED DURING INITIAL ACCESS. THE MANTA DEVICE WAS NEVER EXPLANTED AND THE SURGICAL CUTDOWN WAS TO REPAIR THE FEMORAL VEIN. THE IC REPORTED THAT THE MANTA DEPLOYMENT WAS NOT CONTRIBUTORY TO DAMAGED VESSEL THAT RESULTED IN THE SURGICAL CUT DOWN. AFTER THE SURGICAL PROCEDURE, IT WAS REPORTED THAT THE PATIENT IS DOING WELL, AND NO HEALTH CONSEQUENCES OCCURRED FROM THIS EVENT."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23714178 ↗
• MalfunctionDec 1, 2025Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT "77YO FEMALE TAVR, RCFA 6.0, NO TORTUOSITY, PVD MILD WITH NO CA++ NOTED. THE 8 FRENCH DEPTH LOCATOR WAS USED; THE MEASUREMENT CAME BACK 5 MILLIMETERS TIMES 2 AND 5 +1 WAS WRITTEN ON THE BOARD. THE DEPTH LOCATOR WAS REMOVED, AND THE 14 FRENCH TAVR SHEATH WAS INSERTED. DOCTOR T. REMOVED THE 14 FRENCH SHEATH AND PREPARED 14 FRENCH MANTA SYSTEM (SHEATH INTRODUCER AND SHEATH) WAS INSERTED OVER A SS WIRE TO THE HUB AND THE INTRODUCER WAS REMOVED. THE BYPASS TUBE WENT THROUGH THE HEMOSTATIC VALVE WITHOUT ISSUE AND USING SMALL PUSHES HE ADVANCED THE CLOSURE DEVICE TO THE LOCKING PART OF THE MANTA SHEATH. DOCTOR T. ATTEMPTED SEVERAL TIMES TO GET THE DEVICE TO LOCK BY PRESSING FORCEFULLY, ROCKING FROM SIDE TO SIDE, AND EVEN REMOVING THE DEVICE PARTIALLY AND REINSERTING IT WITHOUT SUCCESS. THE DECISION WAS MADE TO TRY A NEW DEVICE INSTEAD OF REMOVING THE SHEATH AND STARTING OVER A NEW 14 FRENCH MANTA WAS OPENED AND DROPPED ON THE STERILE FIELD IT WAS LOADED ON THE WIRE AND ADVANCED TO THE HEMOSTATIC VALVE. WITH LITTLE EFFORT THERE WERE TWO CLICKS AS THE DEVICE LOCKED AND MANTA DEVICE WAS DEPLOYED WITHOUT ISSUE SEALING THE GROIN. POST PROCEDURE ANGIOGRAPHY CONFIRMED THE GR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679849 ↗