CLASS II ONGOING Device recall · Reported 2 Sep 2020 · FDA Enforcement Report

Intra-Aortic Ballon Catheters (IABs)-MEGA 30cc IAB recalled by Datascope

Datascope is recalling Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 30cc IAB, distributed nationwide in the US. The recall was initiated on 27 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesKit Lot Number: 3000047044 3000049910 3000055308 3000059274 3000064252 3000067462 3000071220 3000077343 3000084725 3000086853 3000087475 3000087971 3000096716 3000097647 3000100873 3000102114 3000109816 3000047042 3000047931 3000049913 3000055307 3000056433 3000059275 3000060230 3000062405 3000064251 3000067461 3000067855 3000071981 3000071219 3000071982 3000077342 3000080542 3000081080 3000084724 3000086852 3000087972 3000096715 3000090374 3000092556 3000097646 3000102113 3000106149 3000112151 3000114260 3000047043 3000049911 3000064746 3000067463 3000084473 3000097648 3000112153 3000047041 3000047932 3000049912 3000067856 3000071983 3000087476 3000096793 3000097649 3000112152

Quantity recalled1275 kits WW

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-2831-2020
FDA event ID: 85823
Recalling firm: Datascope, Fairfield, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 27 Jul 2020
FDA classified: 21 Aug 2020
Reported: 2 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

27 Jul 2020	Recall initiated by company
21 Aug 2020	Classified by FDA	+25 days
2 Sep 2020	Published in enforcement report	+12 days

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

Reason for recall

Potential Endotoxin Contamination

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Where it was distributed

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.

Nationwide

Questions about this recall

Is Intra-Aortic Ballon Catheters (IABs)-MEGA 30cc IAB recalled?

Yes. Datascope recalled Intra-Aortic Ballon Catheters (IABs)-MEGA 30cc IAB on 27 Jul 2020. The recall is Class II and its status is Ongoing. Recall number Z-2831-2020.

Why was it recalled?

Potential Endotoxin Contamination

Which lots are affected?

Kit Lot Number: 3000047044 3000049910 3000055308 3000059274 3000064252 3000067462 3000071220 3000077343 3000084725 3000086853 3000087475 3000087971 3000096716 3000097647 3000100873 3000102114 3000109816 3000047042 3000047931 3000049913 3000055307 3000056433 3000059275 3000060230 3000062405 3000064251 3000067461 3000067855 3000071981 3000071219 3000071982 3000077342 3000080542 3000081080 3000084724 3000086852 3000087972 3000096715 3000090374 3000092556 3000097646 3000102113 3000106149 3000112151 3000114260 3000047043 3000049911 3000064746 3000067463 3000084473 3000097648 3000112153 3000047041 3000047932 3000049912 3000067856 3000071983 3000087476 3000096793 3000097649 3000112152

Where was it sold?

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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