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

Intra-Aortic Ballon Catheters (IABs)-Yamato Plus-r 30cc Iab recalled

Datascope is recalling Datascope Intra-Aortic Ballon Catheters (IABs)-Yamato Plus-r 30cc 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: 3000045349 3000051218 3000053318 3000055309 3000055310 3000055311 3000056703 3000057316 3000057317 3000057967 3000066213 3000066214 3000068109 3000068110 3000068111 3000069731 3000071412 3000072401 3000072402 3000073682 3000073816 3000073817 3000074887 3000083328 3000083329 3000087746 3000076462 3000078855 3000079319 3000079320 3000083326 3000080308 3000083327 3000087747 3000090530 3000090531 3000092773 3000096367 3000096368 3000095471 3000096369 3000096370 3000096371 3000096372 3000096373 3000096374 3000098749 3000098750 3000103503 3000103504 3000103505 3000103506 3000110580 3000110581 3000110582 3000110583 3000110584 3000113008 3000113009 3000113148 3000115015

Quantity recalled6111 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-2845-2020
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 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - 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 30cc Iab (Japan) Kit recalled?

Yes. Datascope recalled Intra-Aortic Ballon Catheters (IABs)-Yamato Plus-r 30cc Iab (Japan) Kit on 27 Jul 2020. The recall is Class II and its status is Ongoing. Recall number Z-2845-2020.

Why was it recalled?

Potential Endotoxin Contamination

Which lots are affected?

Kit Lot Number: 3000045349 3000051218 3000053318 3000055309 3000055310 3000055311 3000056703 3000057316 3000057317 3000057967 3000066213 3000066214 3000068109 3000068110 3000068111 3000069731 3000071412 3000072401 3000072402 3000073682 3000073816 3000073817 3000074887 3000083328 3000083329 3000087746 3000076462 3000078855 3000079319 3000079320 3000083326 3000080308 3000083327 3000087747 3000090530 3000090531 3000092773 3000096367 3000096368 3000095471 3000096369 3000096370 3000096371 3000096372 3000096373 3000096374 3000098749 3000098750 3000103503 3000103504 3000103505 3000103506 3000110580 3000110581 3000110582 3000110583 3000110584 3000113008 3000113009 3000113148 3000115015

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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