Device recall: Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087

Class II FDA enforcement event 82703. Recall start date: 18 Apr 2019. Status in the FDA record: Terminated. Termination date: 28 Jul 2025.

Reason for recall, in the words of FDA

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Class II, in the words of FDA

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

Maquet Cardiovascular, LLC started this device recall on 18 Apr 2019. The firm address in the FDA record is in Wayne, NJ. FDA put the recall in Class II. FDA event 82703 has 183 product records. The first FDA enforcement report date is 5 Jun 2019. The record gives the status Terminated, with the termination date 28 Jul 2025.

FDA enforcement report The 183 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide

Recalling firm

Maquet Cardiovascular, LLC, Wayne, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

183 product records in the event.

FDA event 82703: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1498-2019	Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087	N/A	Class II	Terminated	5 Jun 2019
Z-1499-2019	Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962	N/A	Class II	Terminated	5 Jun 2019
Z-1500-2019	Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539	N/A	Class II	Terminated	5 Jun 2019
Z-1501-2019	Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690	N/A	Class II	Terminated	5 Jun 2019
Z-1502-2019	Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346	N/A	Class II	Terminated	5 Jun 2019
Z-1503-2019	Maquet Getinge-BEQ-T-22800 Material: 701049506	N/A	Class II	Terminated	5 Jun 2019
Z-1504-2019	Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510	N/A	Class II	Terminated	5 Jun 2019
Z-1505-2019	Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994	N/A	Class II	Terminated	5 Jun 2019
Z-1506-2019	Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060	N/A	Class II	Terminated	5 Jun 2019
Z-1507-2019	Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228	N/A	Class II	Terminated	5 Jun 2019
Z-1508-2019	Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253	N/A	Class II	Terminated	5 Jun 2019
Z-1509-2019	Maquet Getinge-BEQ-TOP 22701 Material: 701050790	N/A	Class II	Terminated	5 Jun 2019
Z-1510-2019	Maquet Getinge-BEQ-TOP 4901 Material: 701050839	N/A	Class II	Terminated	5 Jun 2019
Z-1511-2019	Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859	N/A	Class II	Terminated	5 Jun 2019
Z-1512-2019	Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966	N/A	Class II	Terminated	5 Jun 2019
Z-1513-2019	Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975	N/A	Class II	Terminated	5 Jun 2019
Z-1514-2019	Maquet Getinge-BEQ-TOP 15705 Material: 701051122	N/A	Class II	Terminated	5 Jun 2019
Z-1515-2019	Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179	N/A	Class II	Terminated	5 Jun 2019
Z-1516-2019	Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515	N/A	Class II	Terminated	5 Jun 2019
Z-1517-2019	Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791	N/A	Class II	Terminated	5 Jun 2019
Z-1518-2019	Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285	N/A	Class II	Terminated	5 Jun 2019
Z-1519-2019	Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287	N/A	Class II	Terminated	5 Jun 2019
Z-1520-2019	Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324	N/A	Class II	Terminated	5 Jun 2019
Z-1521-2019	Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461	N/A	Class II	Terminated	5 Jun 2019
Z-1522-2019	Maquet Getinge-BO-TOP 30300 Material:701052623	N/A	Class II	Terminated	5 Jun 2019
Z-1523-2019	Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843	N/A	Class II	Terminated	5 Jun 2019
Z-1524-2019	Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319	N/A	Class II	Terminated	5 Jun 2019
Z-1525-2019	Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361	N/A	Class II	Terminated	5 Jun 2019
Z-1526-2019	Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486	N/A	Class II	Terminated	5 Jun 2019
Z-1527-2019	Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752	N/A	Class II	Terminated	5 Jun 2019
Z-1528-2019	Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754	N/A	Class II	Terminated	5 Jun 2019
Z-1529-2019	Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845	N/A	Class II	Terminated	5 Jun 2019
Z-1530-2019	Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906	N/A	Class II	Terminated	5 Jun 2019
Z-1531-2019	Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150	N/A	Class II	Terminated	5 Jun 2019
Z-1532-2019	Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295	N/A	Class II	Terminated	5 Jun 2019
Z-1533-2019	Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438	N/A	Class II	Terminated	5 Jun 2019
Z-1534-2019	Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776	N/A	Class II	Terminated	5 Jun 2019
Z-1535-2019	Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874	N/A	Class II	Terminated	5 Jun 2019
Z-1536-2019	Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912	N/A	Class II	Terminated	5 Jun 2019
Z-1537-2019	Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142	N/A	Class II	Terminated	5 Jun 2019
Z-1538-2019	Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372	N/A	Class II	Terminated	5 Jun 2019
Z-1539-2019	Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388	N/A	Class II	Terminated	5 Jun 2019
Z-1540-2019	Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601	N/A	Class II	Terminated	5 Jun 2019
Z-1541-2019	Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY Material:	N/A	Class II	Terminated	5 Jun 2019
Z-1542-2019	Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862	N/A	Class II	Terminated	5 Jun 2019
Z-1543-2019	Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866	N/A	Class II	Terminated	5 Jun 2019
Z-1544-2019	Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993	N/A	Class II	Terminated	5 Jun 2019
Z-1545-2019	Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995	N/A	Class II	Terminated	5 Jun 2019
Z-1546-2019	Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041	N/A	Class II	Terminated	5 Jun 2019
Z-1547-2019	Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368	N/A	Class II	Terminated	5 Jun 2019
Z-1548-2019	Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310	N/A	Class II	Terminated	5 Jun 2019
Z-1549-2019	Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473	N/A	Class II	Terminated	5 Jun 2019
Z-1550-2019	Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613	N/A	Class II	Terminated	5 Jun 2019
Z-1551-2019	Maquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899	N/A	Class II	Terminated	5 Jun 2019
Z-1552-2019	Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071	N/A	Class II	Terminated	5 Jun 2019
Z-1553-2019	Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149	N/A	Class II	Terminated	5 Jun 2019
Z-1554-2019	Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255	N/A	Class II	Terminated	5 Jun 2019
Z-1555-2019	Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505	N/A	Class II	Terminated	5 Jun 2019
Z-1556-2019	Maquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560	N/A	Class II	Terminated	5 Jun 2019
Z-1557-2019	Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590	N/A	Class II	Terminated	5 Jun 2019

The table shows 60 of 183 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 183Median of the firm: 1
Events of the firm on the register: 32

Other events of the firm

Other FDA enforcement events of Maquet Cardiovascular, LLC
Initiated	Product (first record)	Type	Class	Records
2 Jun 2026	The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use	Device	Class II	1
15 Aug 2025	Heartstring III Proximal Seal System. Intravascular anastomosis occluder.	Device	Class II	3
6 Aug 2025	Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Har	Device	Class II	1
20 Mar 2025	The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended len	Device	Class II	1
10 Mar 2025	Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2)	Device	Class II	1
9 Dec 2024	VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive	Device	Class I	2
16 Oct 2024	Acrobat-i Positioner. Model Number C-XP-5000Z	Device	Class II	3
20 Sep 2024	VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500	Device	Class I	1
31 May 2024	The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Leng	Device	Class II	2
17 May 2024	The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Numbe	Device	Class II	2

Maquet Cardiovascular, LLC: all 32 events

Official channels

FDA enforcement report Z-1498-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 82703. https://recallregister.com/fda/ii/82703/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide
What quantity of product is in FDA event 82703?: The event has 183 product records. The first record gives this quantity: N/A
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.