MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Summary
The FDA issued a Class II for MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32 by Datascope Corp.. Reason: The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle..
Details
Source
Device Recall
External ID
Z-1462-2023
Action Date
2023-05-03
Status
Ongoing
Category
device
Product Description
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Lot/Code Info: UDI-DI: 10607567111117; Serial Numbers: CB343612K1 CB351306D2 CB360094J2 CB351302D2 CB343613K1 CB359782J2 CB359780J2 CB320625E0 CH207880C5 CB359783J2 CB328500J0 CB356765G2 CB356763G2 CB314092J9 CB355433F2 CB355432F2 CB351305D2 CB311676I9 CB355435F2 CB319727D0 CB319726D0 CB342653J1 CB307113G9 CB360092J2 CH245699K6 CB307117G9 CB360095J2 CB351303D2 CB320623E0 CB320621E0 CB320620E0 CB311677I9 CB314093J9 CB356761G2 CB351307D2 CB329943K0 CB360093J2 CB307111G9 CB343611K1 CB307114G9 CB320624E0 CB351301D2 CB359781J2 CB351304D2 CB356762G2 CB355434F2 CB322068F0 CB342652J1 CB311675I9 CB320622E0 CB355431F2 CB314094J9 CB307112G9 CB307119G9
Quantity Affected: 54 units
Reason for Recall
The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
Distribution
International distribution in the country of Brazil.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-04
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Datascope Corp. has 58 FDA actions in our database, including 58 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Datascope Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Datascope Corp. have FDA actions?
Datascope Corp. has 58 FDA actions in our database, including 58 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1462-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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