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Biotronik BioEnvelope
Elutia Med LLC · Model 440578 · UDI-DI 04035479160548
FTM
Prescription
10
510(k) clearances
11,622
Adverse events (48 deaths)
76
Recalls
89
Facilities
Description
The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.