Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1966-2019·Announced 2019-07-24

Datascope Intra-Aortic Balloon Catheter Recalled for Reversed Date Labels

Datascope is recalling 471 Sensation Plus Intra-Aortic Balloon Catheters because the outer cartons displayed the manufacture and expiry dates in reverse.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error (reversed dates) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Datascope Corporation is recalling 471 units of the Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01. The recall was initiated because the outer cartons were labeled with the manufacture date and the expiry date reversed. This labeling error resulted in the product appearing to be expired before it was manufactured.

The affected products were distributed to Florida in the United States and to 22 foreign countries, including Australia, Austria, Belgium, Estonia, France, Germany, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, the Netherlands, Poland, Russia, Saudi Arabia, Slovakia, Sweden, Switzerland, the United Kingdom, and Ukraine. The recall covers specific lot codes: 3000082472, 3000084069, 3000085231, 3000086994, 3000087688, 3000091205, 3000091206, and 3000091828.

Healthcare providers and facilities should check their inventory for the specific part number and lot codes listed above. If the product is found, it should be removed from use and returned to Datascope Corporation in accordance with their instructions. This recall is classified as Class II by the FDA.

The recalled product

Product: 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…
Manufacturer: Datascope Corporation
Category: Medical Device — Cardiac Assist Device
Hazard: mis-labeling
Affected units: 471

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

UDI Code: 10607567108063
Lot Codes: 3000082472
3000084069
3000085231
3000086994
3000087688
3000091205
3000091206
3000091828

Distribution

Distributed in 1 state:

Same manufacturer · Datascope Corporation

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Same hazard · mis labeling