> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# QS, MDR Violations at Datascope
- URL: https://www.fdaweb.com/qs-mdr-violations-at-datascope/
- Published: 2018-10-02T12:00:00.000Z
- Updated: 2026-09-15T00:35:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142488

A 3/19-6/11 FDA inspection at Datascope Corp., Fairfield, NJ, found Quality System regulation and Medical Device Reporting regulation violations in the firm’s manufacturing of the Sensation Plus 8Fr intra-aortic balloon catheter, Mega 7.5 Fr intra-aortic balloon catheter, Sensation Plus 7.5 Fr intra-aortic balloon catheter, and cardiopulmonary bypass tubing packs. A 9/11 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm621899.htm?ref=fdaweb.com) says specific violations were: 

- failing to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants;
- failing to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation;
- failing to submit a report to FDA no later than 30 days after the day that the firm received or otherwise became aware of information from any source reasonably suggesting that a device it markets may have caused or contributed to a death or serious injury;
- failing to submit a report to FDA no later than 30 days after receiving or otherwise becoming aware of information that a device the firm markets has malfunctioned and that device or a similar device that the firm markets would be likely to cause or contribute to a death or serious injury; and
- failing to adequately develop, maintain, and implement written Medical Device Reporting procedures.

Datascope was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each step, and a timetable for completion.