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

Intra-Aortic Ballon Catheters (IABs)-Sensation 34cc IAB Kit recalled

Datascope is recalling Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 34cc IAB 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: 3000045657 3000047164 3000048708 3000049477 3000050927 3000051753 3000051754 3000052790 3000053815 3000053816 3000056436 3000058893 3000059906 3000063263 3000064521 3000065233 3000066677 3000067689 3000071413 3000072399 3000074269 3000075922 3000077813 3000080874 3000081078 3000083096 3000084472 3000084787 3000086850 3000087366 3000088618 3000089991 3000090768 3000094337 3000097300 3000098247 3000099929 3000102977 3000106755 3000110208 3000111136 3000058894 3000070665 3000073189 3000077203 3000080875 3000084690 3000086792 3000089348 3000094338 3000103213 3000110209 3000045656 3000047710 3000048709 3000049478 3000050926 3000051752 3000052791 3000053817 3000056437 3000059907 3000061290 3000061291 3000064520 3000065234 3000065987 3000066678 3000067690 3000068924 3000069876 3000071218 3000071977 3000071978 3000073188 3000074270 3000076924 3000077812 3000080877 3000081077 3000083095 3000086851 3000087367 3000088617 3000090767 3000092537 3000094336 3000097301 3000098248 3000099928 3000102978 3000106754 3000110207 3000111137 3000046410 3000083097 3000111135 3000103214 3000110210 3000111192

Quantity recalled13335 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-2834-2020
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)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. 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)-Sensation 34cc IAB Kit recalled?

Yes. Datascope recalled Intra-Aortic Ballon Catheters (IABs)-Sensation 34cc IAB Kit on 27 Jul 2020. The recall is Class II and its status is Ongoing. Recall number Z-2834-2020.

Why was it recalled?

Potential Endotoxin Contamination

Which lots are affected?

Kit Lot Number: 3000045657 3000047164 3000048708 3000049477 3000050927 3000051753 3000051754 3000052790 3000053815 3000053816 3000056436 3000058893 3000059906 3000063263 3000064521 3000065233 3000066677 3000067689 3000071413 3000072399 3000074269 3000075922 3000077813 3000080874 3000081078 3000083096 3000084472 3000084787 3000086850 3000087366 3000088618 3000089991 3000090768 3000094337 3000097300 3000098247 3000099929 3000102977 3000106755 3000110208 3000111136 3000058894 3000070665 3000073189 3000077203 3000080875 3000084690 3000086792 3000089348 3000094338 3000103213 3000110209 3000045656 3000047710 3000048709 3000049478 3000050926 3000051752 3000052791 3000053817 3000056437 3000059907 3000061290 3000061291 3000064520 3000065234 3000065987 3000066678 3000067690 3000068924 3000069876 3000071218 3000071977 3000071978 3000073188 3000074270 3000076924 3000077812 3000080877 3000081077 3000083095 3000086851 3000087367 3000088617 3000090767 3000092537 3000094336 3000097301 3000098248 3000099928 3000102978 3000106754 3000110207 3000111137 3000046410 3000083097 3000111135 3000103214 3000110210 3000111192

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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