Reported Mar 11, 2026 · Ongoing
CS300 IABP. Software Version CS300 IABP C.01.
Datascope Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Datascope Corp. · 1300 Macarthur Blvd · Mahwah, NJ · 07430-2052
Is this the product you have?
- CS300 IABP. Software Version CS300 IABP C.01.
- Lot codes and dates
- All Model No; All UDI; All Serial No.
- Amount recalled
- 10,897 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- GA
Why it was recalled
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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