CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report

Intra-Aortic Balloon Catheter Mega 40cc recalled by Datascope

Datascope is recalling Intra-Aortic Balloon Catheter Mega 40cc, distributed nationwide in the US. The recall was initiated on 21 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes0684 00 0295 01U and 0684 00 0295 02U

Quantity recalled2714

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1383-2018
FDA event ID: 79646
Recalling firm: Datascope, Fairfield, NJ
Classification: Class II
Status: Terminated
Recall initiated: 21 Feb 2018
FDA classified: 16 Apr 2018
Reported: 25 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Feb 2018	Recall initiated by company
16 Apr 2018	Classified by FDA	+54 days
25 Apr 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.

Product as listed by the FDA

Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Is Intra-Aortic Balloon Catheter Mega 40cc recalled?

Yes. Datascope recalled Intra-Aortic Balloon Catheter Mega 40cc on 21 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1383-2018.

Why was it recalled?

The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.

Which lots are affected?

0684 00 0295 01U and 0684 00 0295 02U

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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