# FDA recall Z-2986-2020

> **Sorin Group Italia S.r.l.** · Class II · device recall initiated 2020-07-29.

## Product

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.

## Reason for recall

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.

## 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, Sweden, UK, Spain, Italy, France, Belgium, Finland, Greece, Slovenia, Malta, Poland, Romania, Croatia, Hungary, Serbia, Australia, Israel, Georgia, Iran, Kuwait, Oman, Quatar, Singapore, Thailand, Taiwan, Russia, South Africa.

## Key facts

- **Recall number:** Z-2986-2020
- **Recalling firm:** Sorin Group Italia S.r.l.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-29
- **Report date:** 2020-09-30
- **Termination date:** 2021-05-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saluggia, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2986-2020

## Citation

> AI Analytics. FDA recall Z-2986-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2986-2020. Source: US FDA. Licensed CC0.

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