Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA device recall Z-1148-2023 · posted 2023-03-09 · Open, Classified
Recall details
- Recalling firm
- Datascope Corp.
- Reason for recall
- An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.
- Action taken
- On February 7, 2023, the firm notified customers of 4 issues affecting the IABP via an urgent Medical Device Correction letter, which included the present issue. Users were instructed to do the following: 1. If you experience an unexpected shutdown of Cardiosave IABP during therapy, or a frozen or black screen, use another IABP to continue therapy. Until an alternative IABP is located you may attempt to restart the IABP. If the IABP remains non-operational, immediately remove from the patient care environment for further product evaluation. 2. If your device remains inoperable, please contact your service representative to identify the cause and take the necessary actions required. The firm is developing a software correction to address the issue. Once available, a Datascope/Getinge service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- DSP
- Quantity affected
- 4793 (US); 4407 (OUS)
- Distribution
- Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK,
- Date initiated
- 2023-02-07
- Date posted
- 2023-03-09
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOSAVE Intra-Aortic Balloon Pump (K181122) | Datascope Corp. | 2018-05-31 |