# FDA 483 - Medtronic CryoCath LP - October 31, 2024

Source: https://www.keypedia.com/records/483/medtronic-cryocath-lp/e2f41494-1555-4e1d-ba72-6a03083c16f3

> FDA 483 for Medtronic CryoCath LP on October 31, 2024. Product: Device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic CryoCath LP
- Inspection Date: 2024-10-31
- Product Type: Device
- Office Name: Foreign - CBER (Non-Bioresearch Monitoring)
- Summary: The FDA conducted an inspection of Medtronic CryoCath LP, a medical device manufacturer located in Montreal, from October 28 to October 31, 2024. The inspection revealed significant compliance issues, primarily concerning the labeling and identification of medical devices. Specifically, the firm failed to establish adequate procedures to identify finished medical devices labeled as "Sterile" that had not undergone the sterilization process. This oversight was observed in multiple pallets of the Class III PulseSelect Pulsed Field Ablation (PFA) Loop Catheter, which were incorrectly labeled as "Sterile" despite not being sterilized. These devices were not properly marked as "Non-Sterile," posing a risk of distributing non-sterilized products to the U.S. market.

The observations were documented under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. This section mandates that any objectionable conditions observed during inspections be reported to the firm to ensure compliance with FDA regulations. Medtronic CryoCath LP has acknowledged the issue and promised corrective actions to address the labeling and identification deficiencies. The FDA expects the firm to conduct internal audits to identify and rectify any violations of quality system requirements to prevent future occurrences.

## Related Documents

- [483 - 2024-10-31](https://www.keypedia.com/records/483/medtronic-cryocath-lp/5ab99a11-3857-47eb-9fec-e77ae07e0e59)

## Related Officers

- [Felix J. Marrero](https://www.keypedia.com/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.keypedia.com/companies/medtronic-cryocath-lp/af24154a-74f4-435d-beb2-17ce271d1f9b

Office: https://www.keypedia.com/offices/foreign-cber-non-bioresearch-monitoring/8aeaff30-6a57-4624-8035-36c6180197c7