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

Intra-Aortic Ballon Catheters (IABs)-Yamato Plus-r 35cc Iab recalled

Datascope is recalling Datascope Intra-Aortic Ballon Catheters (IABs)-Yamato Plus-r 35cc Iab (Japan) Kit, 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: 3000079504 3000051211 3000051213 3000051214 3000051215 3000051216 3000051217 3000055314 3000056699 3000057319 3000057968 3000058129 3000062638 3000064726 3000068107 3000068108 3000071286 3000072715 3000072716 3000087745 3000090529 3000090660 3000092776 3000076631 3000077754 3000077755 3000080370 3000080371 3000080372 3000080373 3000080374 3000080375 3000080369 3000083330 3000084963 3000084964 3000092777 3000092778 3000095472 3000096375 3000096377 3000096378 3000098752 3000099588 3000099589

Quantity recalled3542 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-2846-2020
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)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - 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)-Yamato Plus-r 35cc Iab (Japan) Kit recalled?

Yes. Datascope recalled Intra-Aortic Ballon Catheters (IABs)-Yamato Plus-r 35cc Iab (Japan) Kit on 27 Jul 2020. The recall is Class II and its status is Ongoing. Recall number Z-2846-2020.

Why was it recalled?

Potential Endotoxin Contamination

Which lots are affected?

Kit Lot Number: 3000079504 3000051211 3000051213 3000051214 3000051215 3000051216 3000051217 3000055314 3000056699 3000057319 3000057968 3000058129 3000062638 3000064726 3000068107 3000068108 3000071286 3000072715 3000072716 3000087745 3000090529 3000090660 3000092776 3000076631 3000077754 3000077755 3000080370 3000080371 3000080372 3000080373 3000080374 3000080375 3000080369 3000083330 3000084963 3000084964 3000092777 3000092778 3000095472 3000096375 3000096377 3000096378 3000098752 3000099588 3000099589

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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