FDA Medical Device Recalls (openFDA)
Datascope Corporation: LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
- Recall number
- Z-2568-2014
- Recalling firm
- Datascope Corporation
- Product
- LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
- Status
- Terminated
- Initiated
- 2014-08-11
- Posted
- 2014-09-03
- Terminated
- 2015-02-05
- Reason
- During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.
- Root cause
- Labeling False and Misleading
- Action
- Maquet Inc.is sued an Urgent Medical Device Recall Letter/ Fax Back Form dated August 11, 2014. Customers are asked to quarantine the affected product and upon return they will be provided with an exchanged unaffected product. The attached form should be completed an returned to Maquet Inc. Questions can be directed to Maquet Technical Support at (888) 627-8383 - Press option "3" followed by option "1" Monday through Friday between the hours of 8 am and 5 pm (EST).
- Quantity
- one unit
- Distribution
- US Distribution to TX.
- Lot, serial or model codes
- Part Number - 0684-00-0480-01U
- 510(k) numbers
- ["K041281"]
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 1000222374
- Firm city
- Fairfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28