Device recall: Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage…
Class II FDA enforcement event 86161. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
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 Italia S.r.l. started this device recall on 29 Jul 2020. The firm address in the FDA record is in Saluggia. FDA put the recall in Class II. FDA event 86161 has 5 product records. The first FDA enforcement report date is 30 Sep 2020. The record gives the status Terminated, with the termination date 17 May 2021.
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 . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution including in the states of CA, FL, ID, ME, MN, MO, MS, NC, SD, OH, OR, PA, SD, TN, TX, VA, WA, WI and the countries of Canada, Japan, Germany, Netherland, Switzerland,…
Recalling firm
Sorin Group Italia S.r.l., Saluggia, N/A, Italy.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2984-2020 | Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. | 77 kits | Class II | Terminated | 30 Sep 2020 |
| Z-2985-2020 | Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. | 94 kits | Class II | Terminated | 30 Sep 2020 |
| Z-2986-2020 | Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. | 102 kits | Class II | Terminated | 30 Sep 2020 |
| Z-2987-2020 | Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. | 225 kits | Class II | Terminated | 30 Sep 2020 |
| Z-2988-2020 | Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. | 498 units (component in kits 1-4) | Class II | Terminated | 30 Sep 2020 |
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 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 5Median of the firm: 5
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Nov 2013 | ORCHESTRA/ORCHESTRA PLUS Programmer Event 67013 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2984-2020The 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.
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Cite this page
Recall Register. FDA enforcement event 86161. https://recallregister.com/fda/ii/86161/. Source: openFDA enforcement reports. Data through .
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:
US Nationwide distribution including in the states of CA, FL, ID, ME, MN, MO, MS, NC, SD, OH, OR, PA, SD, TN, TX, VA, WA, WI and the countries of Canada, Japan, Germany, Netherland, Switzerland,…
- What quantity of product is in FDA event 86161?
- The event has 5 product records. The first record gives this quantity:
77 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.