FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
- Recall number
- Z-1375-2016
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
- Status
- Terminated
- Initiated
- 2016-03-15
- Posted
- not on file
- Terminated
- 2016-08-22
- Reason
- Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve dimensional values on the labels of this lot incorrectly indicate a 50 curve, rather than the correct 86 curve
- Root cause
- Software design
- Action
- The consignee was provided verbal and written notification of the field action on March 15, 2016. There was a total of one (1) consignee, an OEM customer in the USA, who received 25 units. Written notification included product identification information, instruction to immediately quarantine any devices and discontinue distribution, and instructions to initiate a product recall in accordance with their company's established policies for customers to whom they shipped the affected Merit product. An email notification was sent to the Merit sales representative of the affected account. The sales representative was provided a Customer Response Form applicable to their account. The sales representative was instructed to assist the account with the completion of the Customer Response Form and the return of the affected units back to the Merit Field Assurance Department.
- Quantity
- 25
- Distribution
- Distributed to one customer in the US.
- Lot, serial or model codes
- Lot Q823423, Exp 7/31/2018
- 510(k) numbers
- ["K011727"]
- PMA numbers
- not on file
- Product code
- DRC
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- 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