CLASS II Device recall · Reported 24 Jul 2019 · FDA Enforcement Report
Sensation Plus recalled by Datascope
Datascope is recalling Sensation Plus, distributed in Florida. The recall was initiated on 28 May 2019 and the FDA has classified it as Class II.
Check your package
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-1966-2019
- FDA event ID
- 83022
- Recalling firm
- Datascope, Fairfield, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2019
- FDA classified
- 12 Jul 2019
- Reported
- 24 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 28 May 2019 | Recall initiated by company | |
| 12 Jul 2019 | Classified by FDA | +45 days |
| 24 Jul 2019 | 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
The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
Product as listed by the FDA
Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Where it was distributed
The products were distributed to the following US states: FL. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Estonia, France, Germany, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Netherlands, Poland, Russia, Saudi Arabia, Slovakia, Sweden, Switzerland, United Kingdom, Ukraine.
Questions about this recall
Is Sensation Plus recalled?
Yes. Datascope recalled Sensation Plus on 28 May 2019. The recall is Class II and its status is Terminated. Recall number Z-1966-2019.
Why was it recalled?
The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
Which lots are affected?
UDI Code: 10607567108063; Lot Codes: 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, 3000091828
Where was it sold?
The products were distributed to the following US states: FL. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Estonia, France, Germany, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Netherlands, Poland, Russia, Saudi Arabia, Slovakia, Sweden, Switzerland, United Kingdom, Ukraine.
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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Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |