Agency classClass IIOur severity:High FDA (Devices)·Z-2836-2020·Announced 2020-09-02

Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 29,653 kits distributed worldwide.

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: The recall is classified as FDA Class II, and the hazard involves potential endotoxin contamination, which is a significant risk-of-harm factor for medical devices where injury has not yet been reported.

Plain-English summary

Datascope Corporation is recalling specific lots of Datascope Intra-Aortic Balloon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kits due to potential endotoxin contamination. The affected product is used for indications including acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure.

The recall involves 29,653 kits distributed worldwide, including in the United States and numerous international markets. The specific lot numbers affected are: 3000102215, 3000102248, 3000102249, 3000103405, 3000103406, 3000105261, 3000105262, 3000106963, 3000107331, 3000107332, 3000108589, 3000108881, 3000110520, 3000111682, 3000113810, 3000046748, 3000102329, and 3000103404.

Healthcare providers and patients should check their inventory and patient records for these specific lot numbers. If the product is found, it should be removed from use and returned to Datascope Corporation or the distributor for credit or replacement.

The recalled product

Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart…
Manufacturer: Datascope Corporation
Category: Medical Device — Cardiovascular
Hazard: endotoxin-contamination
Affected units: 29,653

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 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 17 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
MEGA Intra-Aortic Balloon Catheter Recalled for Undersized Dilator
FDA (Devices) · 2022-09-14
High
Undersized Dilator in Balloon Catheter Insertion Kit Recalled
FDA (Devices) · 2022-09-14
High
FDA Recalls Sensation Plus Catheter for Undersized Dilator Manufacturing Defect
FDA (Devices) · 2022-09-14
High
Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2020-09-02

Same hazard · endotoxin contamination