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CanGaroo Envelope
Elutia Med LLC · Model CMCV-009-XLG · UDI-DI 00859389005072
FTM
Prescription
10
510(k) clearances
11,622
Adverse events (48 deaths)
76
Recalls
89
Facilities
Description
The CanGaroo® Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo® Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo® Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
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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