SJM™ C0205Recalls & reported problems
St. Jude Medical, Inc. · With EnCap Technology · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734007252), received between Mar 24, 2026 and Mar 24, 2026 — classified as 1 injury.
2 other recalls cover devices cleared under the same FDA submission (K963967); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (b)(6) 2024, A SJM PERICARDIAL PATCH WAS IMPLANTED IN THE PATIENT. ON (b)(6)2025, THE PATCH GOT EXPLANTED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24675763 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K963967. One submission often covers many models, so check the product and lot details in each record.
- Z-0531-2026 · Oct 9, 2025 · Open, ClassifiedSJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
- Z-0532-2026 · Oct 9, 2025 · Open, ClassifiedSJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Other PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE devices
- CryoPatch® SG Pulmonary Human Cardiac Branch Patch SGP020Artivion, Inc. · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2 recalls1 report
- Hemashield M002000195140Intervascular Sas · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1 recall2 reports
- 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.