Food, drugs, devices › Datascope Corporation

Device recall: BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430

FDA enforcement event 79873 · Class II · initiated 19 Oct 2017 · status Terminated · terminated 24 Apr 2020

DeviceVoluntary: Firm initiated28 product recordsFairfield, NJ

FDA enforcement event 79873 is a device recall by Datascope Corporation of Fairfield, NJ, initiated 19 Oct 2017 and classified Class II, with 28 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 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 24 Apr 2020. 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

"The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow."

Distribution

"Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1706-2018	BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430	6	Class II	Terminated	16 May 2018
Z-1707-2018	Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513	1	Class II	Terminated	16 May 2018
Z-1708-2018	Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504	3	Class II	Terminated	16 May 2018
Z-1709-2018	BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01	18	Class II	Terminated	16 May 2018
Z-1710-2018	BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752	3	Class II	Terminated	16 May 2018
Z-1711-2018	BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899	4	Class II	Terminated	16 May 2018
Z-1712-2018	BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179	1	Class II	Terminated	16 May 2018
Z-1713-2018	BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486	10	Class II	Terminated	16 May 2018
Z-1714-2018	BEQ-TOP 22701, Catalog No. 701050790	4	Class II	Terminated	16 May 2018
Z-1715-2018	BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295	9	Class II	Terminated	16 May 2018
Z-1716-2018	BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845	22	Class II	Terminated	16 May 2018
Z-1717-2018	BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01	4	Class II	Terminated	16 May 2018
Z-1718-2018	BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02	10	Class II	Terminated	16 May 2018
Z-1719-2018	BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368	9	Class II	Terminated	16 May 2018
Z-1720-2018	BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02	7	Class II	Terminated	16 May 2018
Z-1721-2018	BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622	9	Class II	Terminated	16 May 2018
Z-1722-2018	BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434	40	Class II	Terminated	16 May 2018
Z-1723-2018	BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370	10	Class II	Terminated	16 May 2018
Z-1724-2018	BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461	18	Class II	Terminated	16 May 2018
Z-1725-2018	NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01	3	Class II	Terminated	16 May 2018
Z-1726-2018	BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253	4	Class II	Terminated	16 May 2018
Z-1727-2018	ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604	4	Class II	Terminated	16 May 2018
Z-1728-2018	BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513	1	Class II	Terminated	16 May 2018
Z-1729-2018	BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504	3	Class II	Terminated	16 May 2018
Z-1730-2018	BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867	18	Class II	Terminated	16 May 2018
Z-1731-2018	BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874	11	Class II	Terminated	16 May 2018
Z-1732-2018	BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966	4	Class II	Terminated	16 May 2018
Z-1733-2018	BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078	2	Class II	Terminated	16 May 2018

Context

93%of 2017 device events are Class II1,091 events that year

28product 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
27 Jul 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-	Device	Class II	17
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
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: "The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow."

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: "Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 24 Apr 2020. "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.