DLP Cardioplegia Adapter with Pressure Port Provides access for a… — Class II medical device recall Z-2766-2017

Terminated recall by Medtronic Perfusion Systems, reported 2017-08-02, distributed nationwide. Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven diff

Recall number	`Z-2766-2017`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Medtronic Perfusion Systems, Brooklyn Park, MN, United States
Recall initiated	2017-06-22
Classified	2017-07-25
Reported by FDA	2017-08-02
Terminated	2020-07-22
Distributed	Nationwide (US)
Countries outside the US	AR, AT, AU, BE, BG, CA, DE, DK, ES, FR, GB, HR, HU, IE, IL, IT, JP, KW, LB, NG, NL, NO, NZ, PL, RO, SI, SV, TH, TR
Reason classes	sterility
UPC / GTIN / UDI-DI	`20613994900412`
Lot numbers	`2016031072`, `2016031509`, `2016050243`, `2016081219`, `2016100630`, `2016120083`, `2016120448`, `2017040113`
Model numbers	`15004`

Product

DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hours

Reason for recall

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2766-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.