TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Reported: May 20, 2020 Initiated: March 6, 2020 #Z-1951-2020
Product Description
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Reason for Recall
Failure to prime due to an assembly error
Details
- Recalling Firm
- Cardiac Assist, Inc
- Units Affected
- 38
- Distribution
- US Nationwide distributions.
- Location
- Pittsburgh, PA
Frequently Asked Questions
What product was recalled? ▼
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.. Recalled by Cardiac Assist, Inc. Units affected: 38.
Why was this product recalled? ▼
Failure to prime due to an assembly error
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2020. Severity: Moderate. Recall number: Z-1951-2020.
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