MANTARecalls & reported problems across all models

We found 3 models of MANTA by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Nov 5, 2025 and Sep 16, 2026 — classified as 17 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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. 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

Most reported MANTA problems

MANTA models

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

• MANTA IPN930507

  Device, hemostasis, vascular
  18 reports
• MANTA IPN930509

  Device, hemostasis, vascular
  6 reports
• MANTA IPN923493

  Device, hemostasis, vascular
  1 report

Recent MANTA adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 3, 2026

  AT THE END OF A TRANSCATHETER AORTIC VALVE REPLACEMENT WITH EDWARDS 23 MM S3 ULTRA VIA PERCUTANEOUS RIGHT TRANSFEMORAL APPROACH. THE CARDIOLOGIST ASSISTED BY THE CATH LAB TECH WAS ATTACHING THE MANTA TO THE SHEATH, THE MANTA CLICKED IN PLACE, AND BLOOD SPRAYED FROM THE CONNECTION SITE ONTO THE TECH, EHS [(ENVIRONMENTAL, HEALTH, AND SAFETY)] PROTOCOLS FOLLOWED. THE CARDIOLOGIST WAS ABLE TO DEPLOY THE COLLAGEN AND SEAL WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245768 ↗
• 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 ↗

Other Teleflex Incorporated products

• ARROW1,494 models · 9,043 reports · 62 recalls
• RUSCH220 models · 436 reports · 130 recalls
• WECK97 models · 3,790 reports · 1 recall
• HUDSON RCI152 models · 1,461 reports · 7 recalls
• LANGSTON4 models · 15 reports · 5 recalls
• PLEUR-EVAC15 models · 146 reports · 1 recall
• LMA AIRWAY MANAGEMENT47 models · 139 reports
• UROLIFT13 models · 137 reports