MANTA IPN923493Recalls & reported problems
Teleflex Incorporated · 18F MANTA Vascular Closure Device · Class 3 · Implant
All models of MANTA (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156109929), received between Feb 3, 2026 and Feb 3, 2026 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Other Device, hemostasis, vascular devices
- Perclose™ ProStyle™ 12773-03Abbott Vascular Inc. · Device, hemostasis, vascular8 deaths18,037 reports
- Perclose ProGlide™ 12673-03Abbott Vascular Inc. · DEVICE, HEMOSTASIS, VASCULAR13 deaths10,588 reports
- ANGIO-SEAL 610130Terumo Medical Corporation · Device, hemostasis, vascular3 deaths1,651 reports
- MYNXGRIP MX6721Cordis US Corp. · Device, hemostasis, vascular3 deaths1,361 reports
- MYNXGRIP MX5021Cordis US Corp. · Device, hemostasis, vascular2 recalls915 reports
- MANTA 2115Essential Medical, Inc. · Device, Hemostasis, Vascular14 deaths966 reports
- StarClose SE™ 14679-01Abbott Vascular Inc. · DEVICE, HEMOSTASIS, VASCULAR589 reports
- Cordis ExoSeal Vascular Closure Device EX500Cordis US Corp. · DEVICE, HEMOSTASIS, VASCULAR500 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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