MANTA IPN928167Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00856279007321), received between Oct 7, 2024 and Feb 10, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Seal” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT "CASE DATE (B)(6)2024 - THE DOCTOR REPORTED THAT THE COLLAGEN HAD BECOME LODGED INSIDE VESSEL WHICH REQUIRED SURGICAL REPAIR". ADDITIONAL INFORMATION: "MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN CENTRAL ACCESS IN THE RIGHT CFA. VESSEL SIZE WAS 9MM WITH MILD CALCIFICATION AND NO REPORTED TORTUOSITY."

  Patient problems: Insufficient Information

  MAUDE report 21342080 ↗
• InjuryJan 3, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "PULSATILE BLEEDING POST DEPLOYMENT". ADDITIONAL INFORMATION: "DURING A PERIPHERAL VENTRICULAR ASSISTED DEVICE PVAD CORONARY INTERVENTION. MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN ACCESS IN THE RIGHT ACCESS AT MID FEMORAL HEAD. VESSEL SIZE WAS 8MM WITH NO REPORTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 3+1CM. 7000 HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. PROTAMINE WAS NOT GIVEN. SYSTOLIC BP WAS 160 AND ACT 297 MANTA WAS DEPLOYED SUCCESSFULLY BUT PULSATILE FLOW WAS PRESENT. DEPLOYMENT WAS CONFIRMED UNDER FLUORO AND PROXIMAL DISSECTION WAS NOTED AFTER IMAGING. PATIENT WAS REPORTED AS FINE POST PROCEDURE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21066697 ↗
• InjuryNov 1, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "PERIPHERAL VENTRICULAR ASSIST DEVICE INSERTION CASE. SIGNIFICANT CALCIUM IN THE RCFA AND ILIAC. MODERATE CALCIUM IN THE LEFT ILIAC PROXIMAL TO THE COMMON FEMORAL. PHYSICIAN STATED THERE WAS RESISTANCE ADVANCING THE PERIPHERAL VENTRICULAR ASSIST DEVICE SHEATH DUE TO MODERATE AMOUNT OF CALCIUM IN THE ILIAC ARTERY. NO ISSUES ADVANCING THE MANTA SHEATH. PHYSICIAN DEPLOYED MANTA PER IFU. CLAIMS THE TENSION PULLING THE MANTA BACK FELT 'DIFFERENT THAN USUAL, LIKE THE FOOTPLATE DID NOT CATCH'. SIGNIFICANT OOZING AT THE SITE. THE STAINLESS-STEEL LOCK WAS NOT SITTING ON THE VESSEL WALL PER THE ANGIO. MANUAL PRESSURE WAS HELD ON THE SITE FOR AN HOUR AND HALF. LATER, THE PATIENT WENT TO SURGERY AND HAD THE MANTA REMOVED BY INCISION AND REPAIR THE VESSEL. SURGEON STATED WHEN MANTA DEVICE WAS REMOVED, BLEEDING OCCURRED. PATIENT IS STABLE AND GOING HOME ON (B)(6) 2024." ADDITIONAL INFORMATION: "MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN LOWER ACCESS IN THE LEFT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 6MM WITH MODERATE TO SEVERE POSTERIOR CALCIFICATION. MEASURED DEPTH FOR THE MANTA WAS 3+1CM. THERE WAS NO REPORTED PATIENT HARM POST THE DEVICE ISSUE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20585750 ↗
• MalfunctionOct 7, 2024Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT "DR. HAD TROUBLE INSERTING THE BYPASS TUBE INTO THE SHEATH, HE EVENTUALLY GOT IT IN, BUT IT TOOK A LOT OF EFFORT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381656 ↗