Device recall: SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA

Class II FDA enforcement event 77810. Recall start date: 29 Jun 2017. Status in the FDA record: Terminated. Termination date: 12 Apr 2021.

Reason for recall, in the words of FDA

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

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

Sorin Group USA, Inc. started this device recall on 29 Jun 2017. The firm address in the FDA record is in Arvada, CO. FDA put the recall in Class II. FDA event 77810 has 16 product records. The first FDA enforcement report date is 9 Aug 2017. The record gives the status Terminated, with the termination date 12 Apr 2021.

FDA enforcement report The 16 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

Sorin Group USA, Inc., Arvada, CO.

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

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

Products

16 product records in the event.

FDA event 77810: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2783-2017	SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA	50 units	Class II	Terminated	9 Aug 2017
Z-2784-2017	SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA	98 units	Class II	Terminated	9 Aug 2017
Z-2785-2017	SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA	524 units	Class II	Terminated	9 Aug 2017
Z-2786-2017	SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA	52 units	Class II	Terminated	9 Aug 2017
Z-2787-2017	SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA	632 units	Class II	Terminated	9 Aug 2017
Z-2788-2017	SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA	733 units	Class II	Terminated	9 Aug 2017
Z-2789-2017	SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA	5 units	Class II	Terminated	9 Aug 2017
Z-2790-2017	SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA	32 units	Class II	Terminated	9 Aug 2017
Z-2791-2017	STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA	1 unit	Class II	Terminated	9 Aug 2017
Z-2792-2017	SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA	54 units	Class II	Terminated	9 Aug 2017
Z-2793-2017	SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA	8 units	Class II	Terminated	9 Aug 2017
Z-2794-2017	SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA	1 unit	Class II	Terminated	9 Aug 2017
Z-2795-2017	SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA	4 units	Class II	Terminated	9 Aug 2017
Z-2796-2017	NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE	1 unit	Class II	Terminated	9 Aug 2017
Z-2797-2017	NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE	1 unit	Class II	Terminated	9 Aug 2017
Z-2798-2017	NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE	1 unit	Class II	Terminated	9 Aug 2017

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 2017: 1,091
Share of these events in Class II: 93%
Product records in this event: 16Median of the firm: 1
Events of the firm on the register: 19

Other events of the firm

Other FDA enforcement events of Sorin Group USA, Inc.
Initiated	Product (first record)	Type	Class	Records
28 Sep 2017	FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a	Device	Class II	1
30 Jun 2017	STOCKERT Heater-Cooler System 3T, 230 V	Device	Class II	6
9 Jun 2017	Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are ind	Device	Class II	1
31 Oct 2016	Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M,	Device	Class II	1
29 Sep 2016	The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implant	Device	Class II	2
25 Aug 2016	Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S	Device	Class II	1
12 Aug 2016	Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae ar	Device	Class II	2
22 Jun 2016	AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) A	Device	Class II	1
25 Jan 2016	Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration	Device	Class II	1
19 Jan 2016	CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Produ	Device	Class III	1

Sorin Group USA, Inc.: all 19 events

Official channels

FDA enforcement report Z-2783-2017The 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 77810. https://recallregister.com/fda/ii/77810/. 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 77810?: The event has 16 product records. The first record gives this quantity: 50 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2017 have the same class?: 93% of the 1,091 device events that started in 2017 are in Class II.