Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Summary
The FDA issued a Class II for Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , M by Datascope Corp.. Reason: There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement vo.
Details
Source
Device Recall
External ID
Z-1279-2023
Action Date
2023-03-29
Status
Ongoing
Category
device
Product Description
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Lot/Code Info: Serial Numbers: MH353075E2 MH353057E2 MH353067E2 MH353077E2 MH356112G2 MH353056E2 MH356111G2 MH356119G2 MH353065E2 MH356117G2
Quantity Affected: 10
Reason for Recall
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Distribution
Distribution list not yet provided.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-28
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 128 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-1279-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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