Impra® ePTFE Cardiovascular Patch 100P15006Recalls & reported problems
Bard Peripheral Vascular, Inc. · Impra® ePTFE Cardiovascular Patch 100 mm x 150 mm, Regular wall · Class 2 · Implant
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741041457), received between Feb 13, 2018 and Jun 29, 2022 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (14 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material14
- Nonstandard Device14
- Difficult to Open or Remove Packaging Material12
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Patient Involvement2
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14849538 ↗MalfunctionJun 28, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14840480 ↗MalfunctionJun 28, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14840472 ↗MalfunctionJun 28, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14840363 ↗MalfunctionJun 28, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14840070 ↗MalfunctionJun 27, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14826572 ↗MalfunctionJun 27, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14826509 ↗MalfunctionJun 27, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14826156 ↗MalfunctionJun 27, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14826152 ↗MalfunctionJun 27, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14826075 ↗MalfunctionJun 27, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14826069 ↗MalfunctionJun 27, 2022Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material; Nonstandard Device; Difficult to Open or Remove Packaging Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, THE PATCHES ALLEGEDLY HAD A DEPOSIT APPEARANCE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14825897 ↗MalfunctionFeb 13, 2018Nonstandard Device; Device Contamination with Chemical or Other Material; Nonstandard Device; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATERIAL WAS ALLEGEDLY DISCOVERED ON THE CARDIOVASCULAR PATCH UPON OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7268634 ↗MalfunctionFeb 13, 2018Nonstandard Device; Device Contamination with Chemical or Other Material; Nonstandard Device; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATERIAL WAS ALLEGEDLY DISCOVERED ON THE CARDIOVASCULAR PATCH UPON OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7268619 ↗
Other PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE devices
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- CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch SGPH00Artivion, Inc. · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 recall0 reports
- SJM™ C0510St. Jude Medical, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- SJM™ C0914St. Jude Medical, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- Supple Peri-Guard PC0814SNSynovis Life Technologies, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- Peri-Guard PC0404NSynovis Life Technologies, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE1 recall0 reports
- Bard® PTFE Felt Pledgets 007963Bard Peripheral Vascular, Inc. · PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE37 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.