CLASS I Device recall · Reported 2 Aug 2017 · FDA Enforcement Report

CS 100i Intra-Aortic Balloon Pump recalled by Maquet Datascope Corp

Maquet Datascope Corp - Cardiac Assist Division is recalling CS 100i Intra-Aortic Balloon Pump, distributed nationwide in the US. The recall was initiated on 16 Jun 2017 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes0998-UC-0446HXX 0998-UC-0479HXX

Quantity recalled12,319 units total

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-2736-2017
FDA event ID: 77566
Recalling firm: Maquet Datascope Corp - Cardiac Assist Division, Mahwah, NJ
Classification: Class I
Status: Terminated
Recall initiated: 16 Jun 2017
FDA classified: 27 Jul 2017
Reported: 2 Aug 2017
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

16 Jun 2017	Recall initiated by company
27 Jul 2017	Classified by FDA	+41 days
2 Aug 2017	Published in enforcement report	+6 days

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

Reason for recall

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

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

CS 100i Intra-Aortic Balloon Pump

Where it was distributed

Worldwide Distribution - (in over 100 countries) US (Nationwide)

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

0998-UC-0446HXX 0998-UC-0479HXX

Where was it sold?

Worldwide Distribution - (in over 100 countries) US (Nationwide)

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 77566

This product is part of a recall event; the main page for the event is CS 300 Intra-Aortic Balloon Pump recalled by Maquet Datascope Corp.

Reported	Class	Recall	Company	Reason	Where
2 Aug 2017	CLASS I	CS 300 Intra-Aortic Balloon Pump recalled by Maquet Datascope Corp	Maquet Datascope Corp - Cardiac Assist Division	Device Malfunction	Nationwide
2 Aug 2017	CLASS I	CS 100 Intra-Aortic Balloon Pump recalled by Maquet Datascope Corp	Maquet Datascope Corp - Cardiac Assist Division	Device Malfunction	Nationwide

More recalls from Maquet Datascope Corp - Cardiac Assist Division

All 14

Reported	Class	Recall	Company	Reason	Where
7 Nov 2018Device	CLASS I	Cardiosave Rescue IABP recalled by Maquet Datascope Corp	Maquet Datascope Corp - Cardiac Assist Division	Other	Nationwide
7 Nov 2018Device	CLASS I	Cardiosave Hybrid IABP recalled by Maquet Datascope Corp	Maquet Datascope Corp - Cardiac Assist Division	Other	Nationwide
6 Jun 2018Device	CLASS I	Cardiosave Hybrid Intra-Aortic Balloon Pump (Iabp) recalled	Maquet Datascope Corp - Cardiac Assist Division	Other	49 states
13 Sep 2017Device	CLASS I	CS 300 Intra-Aortic Balloon Pump recalled by Maquet Datascope Corp	Maquet Datascope Corp - Cardiac Assist Division	Device Malfunction	Nationwide
13 Sep 2017Device	CLASS I	CS 100i Intra-Aortic Balloon Pump recalled by Maquet Datascope Corp	Maquet Datascope Corp - Cardiac Assist Division	Device Malfunction	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide