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

Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 40cc IAB (Japan) recalled

Datascope is recalling Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 40cc IAB (Japan), 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: 3000051381 3000053316 3000057969 3000062074 3000066987 3000062557 3000062558 3000066988 3000064524 3000066989 3000066990 3000067890 3000069733 3000074397 3000074398 3000077670 3000077671 3000078857 3000080306 3000080310 3000083334 3000083335 3000084272 3000084969 3000087490 3000087491 3000092779 3000092780 3000095470 3000096586 3000098053 3000098054 3000098055 3000098056 3000099590 3000099591 3000112273 3000107761 3000107762 3000112274

Quantity recalled3059 Kits

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-2842-2020
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)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01

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)-Trans-Ray 40cc IAB (Japan) recalled?

Yes. Datascope recalled Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 40cc IAB (Japan) on 27 Jul 2020. The recall is Class II and its status is Ongoing. Recall number Z-2842-2020.

Why was it recalled?

Potential Endotoxin Contamination

Which lots are affected?

Kit Lot Number: 3000051381 3000053316 3000057969 3000062074 3000066987 3000062557 3000062558 3000066988 3000064524 3000066989 3000066990 3000067890 3000069733 3000074397 3000074398 3000077670 3000077671 3000078857 3000080306 3000080310 3000083334 3000083335 3000084272 3000084969 3000087490 3000087491 3000092779 3000092780 3000095470 3000096586 3000098053 3000098054 3000098055 3000098056 3000099590 3000099591 3000112273 3000107761 3000107762 3000112274

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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