CLASS II ONGOING Device recall · Reported 14 Sep 2022 · FDA Enforcement Report

Insertion Kit for use with Sensation Plus 8F recalled by Datascope

Datascope is recalling Insertion Kit for use with Sensation Plus 8F. The recall was initiated on 5 Aug 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCode information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567108599, 3000170709, 0884-00-0019-23; 10607567108599, 3000182611, 0884-00-0019-23; 10607567108599, 3000202083, 0884-00-0019-23

Quantity recalled10,427 units

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-1687-2022
FDA event ID: 90684
Recalling firm: Datascope, Fairfield, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 5 Aug 2022
FDA classified: 8 Sep 2022
Reported: 14 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

5 Aug 2022	Recall initiated by company
8 Sep 2022	Classified by FDA	+34 days
14 Sep 2022	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

Certain lots containing undersized dilator.

Product as listed by the FDA

Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter

Where it was distributed

Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

Questions about this recall

Is Insertion Kit for use with Sensation Plus 8F recalled?

Yes. Datascope recalled Insertion Kit for use with Sensation Plus 8F on 5 Aug 2022. The recall is Class II and its status is Ongoing. Recall number Z-1687-2022.

Why was it recalled?

Certain lots containing undersized dilator.

Which lots are affected?

Code information reads "UDI-DI, Lot No., Finished Goods Part No.": 10607567108599, 3000170709, 0884-00-0019-23; 10607567108599, 3000182611, 0884-00-0019-23; 10607567108599, 3000202083, 0884-00-0019-23

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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