TigerPaw Pro Left Atrial Appendage Closure Device 35mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10607567510996), received between Feb 19, 2021 and Mar 12, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Noise, Audible” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE TIGERPAW PRO (TPP) CLIP, A LOUD "CRACKLING" NOISE WAS HEARD. FOLLOWING DEPLOYMENT, BLEEDING WAS OBSERVED AT THE DISTAL, POSTERIOR END OF THE LEFT ATRIAL APPENDAGE (LAA). THE PHYSICIAN USED PLEDGETED STITCHES TO STOP THE BLEEDING. A SEPARATE REPORT HAS BEEN SUBMITTED FOR THE "CRACKLING" NOISE UNDER MFG REPORT NUMBER 2248146-2021-00107.

  Patient problems: Laceration(s)

  MAUDE report 11477968 ↗
• InjuryFeb 19, 2021Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE TIGERPAW PRO (TPP) CLIP, A LOUD "CRACKLING" NOISE WAS HEARD. FOLLOWING DEPLOYMENT, BLEEDING WAS OBSERVED AT THE DISTAL, POSTERIOR END OF THE LEFT ATRIAL APPENDAGE (LAA). THE PHYSICIAN USED PLEDGETED STITCHES TO STOP THE BLEEDING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Injury

  MAUDE report 11353712 ↗
• InjuryFeb 19, 2021Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE TIGERPAW PRO (TPP) CLIP, A LOUD "CRACKLING" NOISE WAS HEARD. FOLLOWING DEPLOYMENT, BLEEDING WAS OBSERVED AT THE DISTAL, POSTERIOR END OF THE LEFT ATRIAL APPENDAGE (LAA). THE PATIENT WAS PUT ON ON-PUMP CORONARY ARTERY BYPASS. THE PHYSICIAN NOTED THAT THE PATIENT HAD A LOW EJECTION FRACTION (EF) AND REQUIRED FOUR PLEDGETED STITCHES TO REPAIR THE TEAR. THE PHYSICIAN BELIEVES THE DISTAL TIPS OF THE TPP CAN/ARE CRUSHING THE DISTAL END OF THE LAA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Injury

  MAUDE report 11352817 ↗
• MalfunctionFeb 19, 2021Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE TIGERPAW PRO (TPP) CLIP, THE PHYSICIAN HEARD THE HANDLE/ TRIGGER MAKE A "GRINDING" NOISE. FOLLOWING VISUAL CONFIRMATION, IT WAS DETERMINED THAT NO BLEEDING / TEAR HAS OCCURRED AND ALL TPP CONNECTOR BARBS WERE CORRECTLY CONNECTED. THE PHYSICIAN CONTINUED AND COMPLETED THE OFF-PUMP CORONARY ARTERY BYPASS (OPCAB) PROCEDURE WITH NO COMPLICATIONS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11351954 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THE TIGERPAW PRO (TPP), THE PHYSICIAN SUCCESSFULLY DEPLOYED THE DEVICE. FOLLOWING DEPLOYMENT, IT WAS DETERMINED THAT THERE WAS BLEEDING FROM THE LEFT ATRIAL APPENDAGE (LAA) ADJACENT TO THE CLIP. THE PHYSICIAN ADDRESSED THE BLEEDING/ TEAR WITH PLEDGETED SUTURE AND COMPLETED THE OFF-PUMP CORONARY ARTERY BYPASS (OPCAB) PROCEDURE WITH NO COMPLICATIONS. PRODUCT WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Injury

  MAUDE report 11351032 ↗