Tampa, FL, United States
Cardiocommand Inc. recalls
2 recalls recorded since 2018, most recently on 24 June 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 24 June 2019
- Terminated
- 1 April 2021
- Reason
- There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.
- Distribution
- United States - AR, NM, PA, TX, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1976-2019
- TAPSYSTEM Model 2A, REF 8002A
Terminated Class III Medical devices
- Recall started
- 10 May 2019
- Terminated
- 12 April 2021
- Reason
- Possible corrosion of the battery contact(s).
- Distribution
- US Nationwide distribution in the states of CT, VW, OH, IL, DE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1773-2019
- CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm -
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.