Agency classClass IIOur severity:High FDA (Devices)·Z-1686-2022·Announced 2022-09-14

FDA Recalls Sensation Plus Catheter for Undersized Dilator Manufacturing Defect

Datascope Corporation recalls certain lots of Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheters due to undersized dilators. The manufacturing defect affects approximately 10,427 units distributed internationally and awaiting U.S. distribution.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a manufacturing defect in a critical cardiac device. The undersized dilator may impair proper catheter function. Without reported adverse events in the source, this meets the criteria for High severity as a risk-of-harm product where injury has not been reported.

Plain-English summary

Datascope Corporation is recalling certain lots of the Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter. The recalled units contain an undersized dilator, a manufacturing defect affecting approximately 10,427 units. The Sensation Plus catheter is used to provide mechanical circulatory support in cardiac patients.

The undersized dilator may impair the proper insertion and function of the catheter during clinical use.

The affected units have been distributed to 24 countries internationally and additional units are awaiting domestic distribution in the United States. Specific lot numbers and UDI codes identifying the affected products are available in the FDA recall documentation. Healthcare providers and facilities should immediately discontinue use of the affected lots and contact Datascope Corporation for replacement units or further instructions.

The recalled product

Product: Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Manufacturer: Datascope Corporation
Category: Medical Device — Cardiac Support / Intra-Aortic Balloon Catheter
Hazard: manufacturing-defect
undersized-dilator
Affected units: 10,427

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 (20)

Code information reads "UDI-DI
Lot No.
Finished Goods Part No.": 10607567108605
3000168086
0684-00-0576-01
10607567108605
3000217952
10607567109633
3000166607
0684-00-0576-01U
3000169722
3000172352
3000172353
3000176574
3000176633
3000185680
3000196023
3000199196
3000199197
3000199198

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Datascope Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Datascope Corporation

See all →

High
LINEAR Intra-Aortic Balloon Catheter Recalled for Incorrect Volume Labeling
FDA (Devices) · 2022-11-02
High
Undersized Dilator in Balloon Catheter Insertion Kit Recalled
FDA (Devices) · 2022-09-14
High
MEGA Intra-Aortic Balloon Catheter Recalled for Undersized Dilator
FDA (Devices) · 2022-09-14
High
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2020-09-02
High
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2020-09-02

Same hazard · manufacturing defect