Food, drugs, devices › Datascope Corporation

Device recall: Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-

FDA enforcement event 85823 · Class II · initiated 27 Jul 2020 · status Ongoing

DeviceVoluntary: Firm initiated17 product recordsFairfield, NJ

FDA enforcement event 85823 is a device recall by Datascope Corporation of Fairfield, NJ, initiated 27 Jul 2020 and classified Class II, with 17 product records.

FDA defines Class II as 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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Datascope Corporation has 14 enforcement events on this register, with a median of 3 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Datascope Corporation, Fairfield, NJ.

Reason for recall

"Potential Endotoxin Contamination"

Distribution

"Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2831-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.	1275 kits WW	Class II	Ongoing	2 Sep 2020
Z-2832-2020	Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery…	16104 WW	Class II	Ongoing	2 Sep 2020
Z-2833-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of…	31529 WW	Class II	Ongoing	2 Sep 2020
Z-2834-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.	13335 WW	Class II	Ongoing	2 Sep 2020
Z-2835-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.	32855 kits	Class II	Ongoing	2 Sep 2020
Z-2836-2020	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 Failure.	29653 kits WW	Class II	Ongoing	2 Sep 2020
Z-2837-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.	69278 kits	Class II	Ongoing	2 Sep 2020
Z-2838-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.	1746 kits WW	Class II	Ongoing	2 Sep 2020
Z-2839-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery…	54816 Kits WW	Class II	Ongoing	2 Sep 2020
Z-2840-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10	116652 Kits WW	Class II	Ongoing	2 Sep 2020
Z-2841-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.	2550 Kits	Class II	Ongoing	2 Sep 2020
Z-2842-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01	3059 Kits	Class II	Ongoing	2 Sep 2020
Z-2843-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.	12032 Kits	Class II	Ongoing	2 Sep 2020
Z-2844-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.	11555 Kits	Class II	Ongoing	2 Sep 2020
Z-2845-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.	6111 Kits	Class II	Ongoing	2 Sep 2020
Z-2846-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.	3542 Kits	Class II	Ongoing	2 Sep 2020
Z-2847-2020	Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.	3055 Kits	Class II	Ongoing	2 Sep 2020

Context

93%of 2020 device events are Class II916 events that year

17product records in this eventfirm median: 3

14events on this register for the firm

Other enforcement events for Datascope Corporation

Initiated	Product (first record)	Type	Class	Records
5 Aug 2022	LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.	Device	Class II	1
5 Aug 2022	MEGA 8Fr 50cc Intra-Aortic Balloon Catheter	Device	Class II	3
20 Nov 2019	Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous in	Device	Class II	3
28 May 2019	Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: Th	Device	Class II	1
21 Feb 2018	Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used	Device	Class II	3
19 Oct 2017	BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430	Device	Class II	28
27 Jul 2017	Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet	Device	Class II	3
12 Apr 2017	SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00	Device	Class II	1
16 Feb 2017	Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline	Device	Class II	1
13 May 2016	MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Ca	Device	Class II	1

All 14 events for Datascope Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Potential Endotoxin Contamination"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong…"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.