Reported Aug 2, 2017 · Terminated
CS 100 Intra-Aortic Balloon Pump
Maquet Datascope Corp. - Cardiac Assist Division
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Datascope Corp - Cardiac Assist Division · 1300 Macarthur Blvd · Mahwah, NJ · 07430-2052
Is this the product you have?
- CS 100 Intra-Aortic Balloon Pump
- Lot codes and dates
0998-XX-3013-XX0998-UC-3013-XX
- Amount recalled
- 12,319 units total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Maquet Datascope Corp. - Cardiac Assist Division recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.